| Sagent Pharmaceuticals |
25021082902 |
Fomepizole Injection (1.5gm/1.5ml, 1.5ml, 1x1.5ml) |
Generic |
FDA |
2023-12-11 |
985.0000 |
Competitive pricing to match competition. Pricing methodology to price in market higher than the 2nd market leader. |
None |
6739 |
None |
None |
None |
None |
None |
None |
None |
None |
| Sandoz Inc. |
00781215832 |
PIRFENIDONE 267MG 270HGC BO US |
Generic |
FDA |
2023-01-09 |
9130.5700 |
This launch is specific to the U.S. Sandoz Inc. is contracting within the wholesaler and/or specialty pharmacy space. The WAC is priced lower than the WAC of the reference product. |
None |
100000 |
None |
None |
None |
None |
None |
None |
According to Cortellis data from July 2021, IPF is rare disease, with an estimated prevalence of 44,000 to 135,000 cases and an incidence of 21,000 new cases per year in the U.S.
Source: https://insights.decisionresourcesgroup.com/disease/idiopathic-pulmonary-fibrosis.
Acquisition date and acquisition price not applicable; Sandoz Inc. did not acquire the product.
Sandoz Inc. provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Sandoz Inc. does not waive any rights that may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Sandoz Inc. or any of its affiliates now or in the future. Sandoz Inc., on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all Sandoz Inc.’s related information herein is confidential and proprietary commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that your company or organization maintain the confidentiality of this submission and of all Sandoz Inc.’s related information herein to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that your company or organization notify us of the request and afford us the opportunity to submit objections to disclosure. |
None |
| Sandoz Inc. |
00781402822 |
CHLORPROMAZINE 100MG/ML 240ML |
Generic |
FDA |
2023-03-31 |
2160.0000 |
This launch is specific to the U.S. Sandoz Inc. is contracting within the wholesaler and/or specialty pharmacy space. The WAC is priced equal to the previous manufacturer. |
None |
139710 |
None |
None |
2022-12-14 |
1400000.0000 |
None |
Sandoz Inc. provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Sandoz Inc. does not waive any rights that may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Sandoz Inc. or any of its affiliates now or in the future. Sandoz Inc., on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all Sandoz Inc.’s related information herein is confidential and proprietary commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that your company or organization maintain the confidentiality of this submission and of all Sandoz Inc.’s related information herein to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that your company or organization notify us of the request and afford us the opportunity to submit objections to disclosure. |
Chlorpromazine Oral Soultion is indicated for the treatment of multiple conditions including but not limited to the following: the management of manifestations of psychotic disorders, the treatment of schizophrenia, to control nausea and vomiting.
For relief of restlessness and apprehension before surgery, for acute intermittent porphyria, as an adjunct in the treatment of tetanus.
To control the manifestations of the manic type of manic-depressive illness, for relief of intractable hiccups, for the treatment of severe behavioral problems in children (1 to 12 years of age) marked by combativeness and/or explosive hyperexcitable behavior (out of proportion to immediate provocations), and in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability and poor frustration tolerance. There is an estimated 139,710 patients treated with Chlorpromazine Oral Solution in the United States. Source: DailyMEd, FDA label Sandoz Inc. provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Sandoz Inc. does not waive any rights that may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Sandoz Inc. or any of its affiliates now or in the future. Sandoz Inc., on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all Sandoz Inc.’s related information herein is confidential and proprietary commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that your company or organization maintain the confidentiality of this submission and of all Sandoz Inc.’s related information herein to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that your company or organization notify us of the request and afford us the opportunity to submit objections to disclosure. |
None |
| Sandoz Inc. |
61314032764 |
Adalimumab 40MG/0.4ML 2LISY BI US |
Generic |
FDA |
2023-07-05 |
1315.3000 |
Sandoz’s marketing plan for the introduction of Hyrimoz will focus on educating health care professionals (HCPs) and patients (consumers) about the benefit of biosimilars and the approved use of Hyrimoz. Sandoz does not plan to do any direct-to-consumer media advertisements on TV, in magazines, radio, billboards or blogs. Consumer engagement will include our patient website, patient education brochures and emails for those patients that opt into communications and enroll in patient support. Sandoz will offer a patient transition program to patients that transition from Humira to Hyrimoz. HCP engagement will include the HCP website, printed resources, email blasts and other digital resources in line with the Hyrimoz prescribing information. We will provide samples to physician offices but will not provide gifts or sponsor continuing education programs for HCPs. The WAC is priced lower than the WAC of the reference product. |
None |
33782 |
None |
None |
None |
None |
None |
None |
Hyrimoz is a tumor necrosis factor (TNF) blocker indicated for 9 disease states :
1. Rheumatoid Arthritis (RA): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA.
2. Juvenile Idiopathic Arthritis (JIA): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older.
3. Psoriatic Arthritis (PsA): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA.
4. Ankylosing Spondylitis (AS): reducing signs and symptoms in adult patients with active AS.
5. Crohn’s Disease (CD): treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.
6. Ulcerative Colitis (UC): treatment of moderately to severely active ulcerative colitis in adults and pediatric patients 5 years of age and older. Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers.
7. Plaque Psoriasis (Ps): treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.
8. Hidradenitis Suppurativa (HS): treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older.
9. Uveitis (UV): treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. There are an estimated 475,350 patients that could be treated with Hyrimoz in the United States. Source: Label from USFDA (Drugs@FDA). Link: label (fda.gov)
Acquisition date and acquisition price not applicable; Sandoz Inc. did not acquire the product. Sandoz Inc. provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Sandoz Inc. does not waive any rights that may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Sandoz Inc. or any of its affiliates now or in the future. Sandoz Inc., on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all Sandoz Inc.’s related information herein is confidential and proprietary commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that your company or organization maintain the confidentiality of this submission and of all Sandoz Inc.’s related information herein to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that your company or organization notify us of the request and afford us the opportunity to submit objections to disclosure. |
None |
| Sandoz Inc. |
61314032720 |
Adalimumab 40MG/0.4ML 2LISY PE BI US |
Generic |
FDA |
2023-07-05 |
1315.3000 |
Sandoz’s marketing plan for the introduction of Hyrimoz will focus on educating health care professionals (HCPs) and patients (consumers) about the benefit of biosimilars and the approved use of Hyrimoz. Sandoz does not plan to do any direct-to-consumer media advertisements on TV, in magazines, radio, billboards or blogs. Consumer engagement will include our patient website, patient education brochures and emails for those patients that opt into communications and enroll in patient support. Sandoz will offer a patient transition program to patients that transition from Humira to Hyrimoz. HCP engagement will include the HCP website, printed resources, email blasts and other digital resources in line with the Hyrimoz prescribing information. We will provide samples to physician offices but will not provide gifts or sponsor continuing education programs for HCPs. The WAC is priced lower than the WAC of the reference product. |
None |
376201 |
None |
None |
None |
None |
None |
None |
Hyrimoz is a tumor necrosis factor (TNF) blocker indicated for 9 disease states :
1. Rheumatoid Arthritis (RA): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA.
2. Juvenile Idiopathic Arthritis (JIA): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older.
3. Psoriatic Arthritis (PsA): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA.
4. Ankylosing Spondylitis (AS): reducing signs and symptoms in adult patients with active AS.
5. Crohn’s Disease (CD): treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.
6. Ulcerative Colitis (UC): treatment of moderately to severely active ulcerative colitis in adults and pediatric patients 5 years of age and older. Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers.
7. Plaque Psoriasis (Ps): treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.
8. Hidradenitis Suppurativa (HS): treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older.
9. Uveitis (UV): treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. There are an estimated 475,350 patients that could be treated with Hyrimoz in the United States. Source: Label from USFDA (Drugs@FDA). Link: label (fda.gov)
Acquisition date and acquisition price not applicable; Sandoz Inc. did not acquire the product. Sandoz Inc. provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Sandoz Inc. does not waive any rights that may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Sandoz Inc. or any of its affiliates now or in the future. Sandoz Inc., on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all Sandoz Inc.’s related information herein is confidential and proprietary commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that your company or organization maintain the confidentiality of this submission and of all Sandoz Inc.’s related information herein to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that your company or organization notify us of the request and afford us the opportunity to submit objections to disclosure. |
None |
| Sandoz Inc. |
61314050964 |
HYRIMOZ 10MG/0.1ML 2LISY BI US |
Generic |
FDA |
2023-07-05 |
6576.4900 |
Sandoz’s marketing plan for the introduction of Hyrimoz will focus on educating health care professionals (HCPs) and patients (consumers) about the benefit of biosimilars and the approved use of Hyrimoz. Sandoz does not plan to do any direct-to-consumer media advertisements on TV, in magazines, radio, billboards or blogs. Consumer engagement will include our patient website, patient education brochures and emails for those patients that opt into communications and enroll in patient support. Sandoz will offer a patient transition program to patients that transition from Humira to Hyrimoz. HCP engagement will include the HCP website, printed resources, email blasts and other digital resources in line with the Hyrimoz prescribing information. We will provide samples to physician offices but will not provide gifts or sponsor continuing education programs for HCPs. The WAC is priced lower than the WAC of the reference product. |
None |
202 |
None |
None |
None |
None |
None |
None |
Hyrimoz is a tumor necrosis factor (TNF) blocker indicated for 9 disease states :
1. Rheumatoid Arthritis (RA): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA.
2. Juvenile Idiopathic Arthritis (JIA): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older.
3. Psoriatic Arthritis (PsA): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA.
4. Ankylosing Spondylitis (AS): reducing signs and symptoms in adult patients with active AS.
5. Crohn’s Disease (CD): treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.
6. Ulcerative Colitis (UC): treatment of moderately to severely active ulcerative colitis in adults and pediatric patients 5 years of age and older. Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers.
7. Plaque Psoriasis (Ps): treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.
8. Hidradenitis Suppurativa (HS): treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older.
9. Uveitis (UV): treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. There are an estimated 475,350 patients that could be treated with Hyrimoz in the United States. Source: Label from USFDA (Drugs@FDA). Link: label (fda.gov)
Acquisition date and acquisition price not applicable; Sandoz Inc. did not acquire the product. Sandoz Inc. provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Sandoz Inc. does not waive any rights that may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Sandoz Inc. or any of its affiliates now or in the future. Sandoz Inc., on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all Sandoz Inc.’s related information herein is confidential and proprietary commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that your company or organization maintain the confidentiality of this submission and of all Sandoz Inc.’s related information herein to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that your company or organization notify us of the request and afford us the opportunity to submit objections to disclosure. |
None |
| Sandoz Inc. |
61314047664 |
HYRIMOZ 20MG/0.2ML 2LISY BI US |
Generic |
FDA |
2023-07-05 |
6576.4900 |
Sandoz’s marketing plan for the introduction of Hyrimoz will focus on educating health care professionals (HCPs) and patients (consumers) about the benefit of biosimilars and the approved use of Hyrimoz. Sandoz does not plan to do any direct-to-consumer media advertisements on TV, in magazines, radio, billboards or blogs. Consumer engagement will include our patient website, patient education brochures and emails for those patients that opt into communications and enroll in patient support. Sandoz will offer a patient transition program to patients that transition from Humira to Hyrimoz. HCP engagement will include the HCP website, printed resources, email blasts and other digital resources in line with the Hyrimoz prescribing information. We will provide samples to physician offices but will not provide gifts or sponsor continuing education programs for HCPs. The WAC is priced lower than the WAC of the reference product. |
None |
2630 |
None |
None |
None |
None |
None |
None |
Hyrimoz is a tumor necrosis factor (TNF) blocker indicated for 9 disease states :
1. Rheumatoid Arthritis (RA): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA.
2. Juvenile Idiopathic Arthritis (JIA): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older.
3. Psoriatic Arthritis (PsA): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA.
4. Ankylosing Spondylitis (AS): reducing signs and symptoms in adult patients with active AS.
5. Crohn’s Disease (CD): treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.
6. Ulcerative Colitis (UC): treatment of moderately to severely active ulcerative colitis in adults and pediatric patients 5 years of age and older. Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers.
7. Plaque Psoriasis (Ps): treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.
8. Hidradenitis Suppurativa (HS): treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older.
9. Uveitis (UV): treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. There are an estimated 475,350 patients that could be treated with Hyrimoz in the United States. Source: Label from USFDA (Drugs@FDA). Link: label (fda.gov)
Acquisition date and acquisition price not applicable; Sandoz Inc. did not acquire the product. Sandoz Inc. provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Sandoz Inc. does not waive any rights that may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Sandoz Inc. or any of its affiliates now or in the future. Sandoz Inc., on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all Sandoz Inc.’s related information herein is confidential and proprietary commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that your company or organization maintain the confidentiality of this submission and of all Sandoz Inc.’s related information herein to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that your company or organization notify us of the request and afford us the opportunity to submit objections to disclosure. |
None |
| Sandoz Inc. |
61314047364 |
HYRIMOZ 40MG/0.4ML 2LISY BI US |
Generic |
FDA |
2023-07-05 |
6576.4900 |
Sandoz’s marketing plan for the introduction of Hyrimoz will focus on educating health care professionals (HCPs) and patients (consumers) about the benefit of biosimilars and the approved use of Hyrimoz. Sandoz does not plan to do any direct-to-consumer media advertisements on TV, in magazines, radio, billboards or blogs. Consumer engagement will include our patient website, patient education brochures and emails for those patients that opt into communications and enroll in patient support. Sandoz will offer a patient transition program to patients that transition from Humira to Hyrimoz. HCP engagement will include the HCP website, printed resources, email blasts and other digital resources in line with the Hyrimoz prescribing information. We will provide samples to physician offices but will not provide gifts or sponsor continuing education programs for HCPs. The WAC is priced lower than the WAC of the reference product. |
None |
33782 |
None |
None |
None |
None |
None |
None |
Hyrimoz is a tumor necrosis factor (TNF) blocker indicated for 9 disease states :
1. Rheumatoid Arthritis (RA): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA.
2. Juvenile Idiopathic Arthritis (JIA): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older.
3. Psoriatic Arthritis (PsA): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA.
4. Ankylosing Spondylitis (AS): reducing signs and symptoms in adult patients with active AS.
5. Crohn’s Disease (CD): treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.
6. Ulcerative Colitis (UC): treatment of moderately to severely active ulcerative colitis in adults and pediatric patients 5 years of age and older. Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers.
7. Plaque Psoriasis (Ps): treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.
8. Hidradenitis Suppurativa (HS): treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older.
9. Uveitis (UV): treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. There are an estimated 475,350 patients that could be treated with Hyrimoz in the United States. Source: Label from USFDA (Drugs@FDA). Link: label (fda.gov)
Acquisition date and acquisition price not applicable; Sandoz Inc. did not acquire the product. Sandoz Inc. provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Sandoz Inc. does not waive any rights that may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Sandoz Inc. or any of its affiliates now or in the future. Sandoz Inc., on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all Sandoz Inc.’s related information herein is confidential and proprietary commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that your company or organization maintain the confidentiality of this submission and of all Sandoz Inc.’s related information herein to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that your company or organization notify us of the request and afford us the opportunity to submit objections to disclosure. |
None |
| Sandoz Inc. |
61314047320 |
HYRIMOZ 40MG/0.4ML 2LISY PE BI US |
Generic |
FDA |
2023-07-05 |
6576.4900 |
Sandoz’s marketing plan for the introduction of Hyrimoz will focus on educating health care professionals (HCPs) and patients (consumers) about the benefit of biosimilars and the approved use of Hyrimoz. Sandoz does not plan to do any direct-to-consumer media advertisements on TV, in magazines, radio, billboards or blogs. Consumer engagement will include our patient website, patient education brochures and emails for those patients that opt into communications and enroll in patient support. Sandoz will offer a patient transition program to patients that transition from Humira to Hyrimoz. HCP engagement will include the HCP website, printed resources, email blasts and other digital resources in line with the Hyrimoz prescribing information. We will provide samples to physician offices but will not provide gifts or sponsor continuing education programs for HCPs. The WAC is priced lower than the WAC of the reference product. |
None |
376201 |
None |
None |
None |
None |
None |
None |
Hyrimoz is a tumor necrosis factor (TNF) blocker indicated for 9 disease states :
1. Rheumatoid Arthritis (RA): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA.
2. Juvenile Idiopathic Arthritis (JIA): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older.
3. Psoriatic Arthritis (PsA): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA.
4. Ankylosing Spondylitis (AS): reducing signs and symptoms in adult patients with active AS.
5. Crohn’s Disease (CD): treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.
6. Ulcerative Colitis (UC): treatment of moderately to severely active ulcerative colitis in adults and pediatric patients 5 years of age and older. Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers.
7. Plaque Psoriasis (Ps): treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.
8. Hidradenitis Suppurativa (HS): treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older.
9. Uveitis (UV): treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. There are an estimated 475,350 patients that could be treated with Hyrimoz in the United States. Source: Label from USFDA (Drugs@FDA). Link: label (fda.gov)
Acquisition date and acquisition price not applicable; Sandoz Inc. did not acquire the product. Sandoz Inc. provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Sandoz Inc. does not waive any rights that may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Sandoz Inc. or any of its affiliates now or in the future. Sandoz Inc., on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all Sandoz Inc.’s related information herein is confidential and proprietary commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that your company or organization maintain the confidentiality of this submission and of all Sandoz Inc.’s related information herein to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that your company or organization notify us of the request and afford us the opportunity to submit objections to disclosure. |
None |
| Sandoz Inc. |
61314051736 |
HYRIMOZ 80+40MG 3 KIT PE BI US |
Generic |
FDA |
2023-07-05 |
13153.0100 |
Sandoz’s marketing plan for the introduction of Hyrimoz will focus on educating health care professionals (HCPs) and patients (consumers) about the benefit of biosimilars and the approved use of Hyrimoz. Sandoz does not plan to do any direct-to-consumer media advertisements on TV, in magazines, radio, billboards or blogs. Consumer engagement will include our patient website, patient education brochures and emails for those patients that opt into communications and enroll in patient support. Sandoz will offer a patient transition program to patients that transition from Humira to Hyrimoz. HCP engagement will include the HCP website, printed resources, email blasts and other digital resources in line with the Hyrimoz prescribing information. We will provide samples to physician offices but will not provide gifts or sponsor continuing education programs for HCPs. The WAC is priced lower than the WAC of the reference product. |
None |
14213 |
None |
None |
None |
None |
None |
None |
Hyrimoz is a tumor necrosis factor (TNF) blocker indicated for 9 disease states :
1. Rheumatoid Arthritis (RA): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA.
2. Juvenile Idiopathic Arthritis (JIA): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older.
3. Psoriatic Arthritis (PsA): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA.
4. Ankylosing Spondylitis (AS): reducing signs and symptoms in adult patients with active AS.
5. Crohn’s Disease (CD): treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.
6. Ulcerative Colitis (UC): treatment of moderately to severely active ulcerative colitis in adults and pediatric patients 5 years of age and older. Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers.
7. Plaque Psoriasis (Ps): treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.
8. Hidradenitis Suppurativa (HS): treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older.
9. Uveitis (UV): treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. There are an estimated 475,350 patients that could be treated with Hyrimoz in the United States. Source: Label from USFDA (Drugs@FDA). Link: label (fda.gov)
Acquisition date and acquisition price not applicable; Sandoz Inc. did not acquire the product. Sandoz Inc. provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Sandoz Inc. does not waive any rights that may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Sandoz Inc. or any of its affiliates now or in the future. Sandoz Inc., on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all Sandoz Inc.’s related information herein is confidential and proprietary commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that your company or organization maintain the confidentiality of this submission and of all Sandoz Inc.’s related information herein to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that your company or organization notify us of the request and afford us the opportunity to submit objections to disclosure. |
None |
| Sandoz Inc. |
61314045420 |
HYRIMOZ 80MG/0.8ML 2LISY PE BI US |
Generic |
FDA |
2023-07-05 |
13153.0100 |
Sandoz’s marketing plan for the introduction of Hyrimoz will focus on educating health care professionals (HCPs) and patients (consumers) about the benefit of biosimilars and the approved use of Hyrimoz. Sandoz does not plan to do any direct-to-consumer media advertisements on TV, in magazines, radio, billboards or blogs. Consumer engagement will include our patient website, patient education brochures and emails for those patients that opt into communications and enroll in patient support. Sandoz will offer a patient transition program to patients that transition from Humira to Hyrimoz. HCP engagement will include the HCP website, printed resources, email blasts and other digital resources in line with the Hyrimoz prescribing information. We will provide samples to physician offices but will not provide gifts or sponsor continuing education programs for HCPs. The WAC is priced lower than the WAC of the reference product. |
None |
12896 |
None |
None |
None |
None |
None |
None |
Hyrimoz is a tumor necrosis factor (TNF) blocker indicated for 9 disease states :
1. Rheumatoid Arthritis (RA): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA.
2. Juvenile Idiopathic Arthritis (JIA): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older.
3. Psoriatic Arthritis (PsA): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA.
4. Ankylosing Spondylitis (AS): reducing signs and symptoms in adult patients with active AS.
5. Crohn’s Disease (CD): treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.
6. Ulcerative Colitis (UC): treatment of moderately to severely active ulcerative colitis in adults and pediatric patients 5 years of age and older. Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers.
7. Plaque Psoriasis (Ps): treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.
8. Hidradenitis Suppurativa (HS): treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older.
9. Uveitis (UV): treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. There are an estimated 475,350 patients that could be treated with Hyrimoz in the United States. Source: Label from USFDA (Drugs@FDA). Link: label (fda.gov)
Acquisition date and acquisition price not applicable; Sandoz Inc. did not acquire the product. Sandoz Inc. provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Sandoz Inc. does not waive any rights that may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Sandoz Inc. or any of its affiliates now or in the future. Sandoz Inc., on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all Sandoz Inc.’s related information herein is confidential and proprietary commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that your company or organization maintain the confidentiality of this submission and of all Sandoz Inc.’s related information herein to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that your company or organization notify us of the request and afford us the opportunity to submit objections to disclosure. |
None |
| Sandoz Inc. |
61314045468 |
HYRIMOZ 80MG/0.8ML 3LISY BI US |
Generic |
FDA |
2023-07-05 |
19729.5400 |
Sandoz’s marketing plan for the introduction of Hyrimoz will focus on educating health care professionals (HCPs) and patients (consumers) about the benefit of biosimilars and the approved use of Hyrimoz. Sandoz does not plan to do any direct-to-consumer media advertisements on TV, in magazines, radio, billboards or blogs. Consumer engagement will include our patient website, patient education brochures and emails for those patients that opt into communications and enroll in patient support. Sandoz will offer a patient transition program to patients that transition from Humira to Hyrimoz. HCP engagement will include the HCP website, printed resources, email blasts and other digital resources in line with the Hyrimoz prescribing information. We will provide samples to physician offices but will not provide gifts or sponsor continuing education programs for HCPs. The WAC is priced lower than the WAC of the reference product. |
None |
273 |
None |
None |
None |
None |
None |
None |
Hyrimoz is a tumor necrosis factor (TNF) blocker indicated for 9 disease states :
1. Rheumatoid Arthritis (RA): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA.
2. Juvenile Idiopathic Arthritis (JIA): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older.
3. Psoriatic Arthritis (PsA): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA.
4. Ankylosing Spondylitis (AS): reducing signs and symptoms in adult patients with active AS.
5. Crohn’s Disease (CD): treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.
6. Ulcerative Colitis (UC): treatment of moderately to severely active ulcerative colitis in adults and pediatric patients 5 years of age and older. Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers.
7. Plaque Psoriasis (Ps): treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.
8. Hidradenitis Suppurativa (HS): treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older.
9. Uveitis (UV): treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. There are an estimated 475,350 patients that could be treated with Hyrimoz in the United States. Source: Label from USFDA (Drugs@FDA). Link: label (fda.gov)
Acquisition date and acquisition price not applicable; Sandoz Inc. did not acquire the product. Sandoz Inc. provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Sandoz Inc. does not waive any rights that may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Sandoz Inc. or any of its affiliates now or in the future. Sandoz Inc., on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all Sandoz Inc.’s related information herein is confidential and proprietary commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that your company or organization maintain the confidentiality of this submission and of all Sandoz Inc.’s related information herein to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that your company or organization notify us of the request and afford us the opportunity to submit objections to disclosure. |
None |
| Sandoz Inc. |
61314045436 |
HYRIMOZ 80MG/0.8ML 3LISY PE BI US |
Generic |
FDA |
2023-07-05 |
19729.5400 |
Sandoz’s marketing plan for the introduction of Hyrimoz will focus on educating health care professionals (HCPs) and patients (consumers) about the benefit of biosimilars and the approved use of Hyrimoz. Sandoz does not plan to do any direct-to-consumer media advertisements on TV, in magazines, radio, billboards or blogs. Consumer engagement will include our patient website, patient education brochures and emails for those patients that opt into communications and enroll in patient support. Sandoz will offer a patient transition program to patients that transition from Humira to Hyrimoz. HCP engagement will include the HCP website, printed resources, email blasts and other digital resources in line with the Hyrimoz prescribing information. We will provide samples to physician offices but will not provide gifts or sponsor continuing education programs for HCPs. The WAC is priced lower than the WAC of the reference product. |
None |
34745 |
None |
None |
None |
None |
None |
None |
Hyrimoz is a tumor necrosis factor (TNF) blocker indicated for 9 disease states :
1. Rheumatoid Arthritis (RA): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA.
2. Juvenile Idiopathic Arthritis (JIA): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older.
3. Psoriatic Arthritis (PsA): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA.
4. Ankylosing Spondylitis (AS): reducing signs and symptoms in adult patients with active AS.
5. Crohn’s Disease (CD): treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.
6. Ulcerative Colitis (UC): treatment of moderately to severely active ulcerative colitis in adults and pediatric patients 5 years of age and older. Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers.
7. Plaque Psoriasis (Ps): treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.
8. Hidradenitis Suppurativa (HS): treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older.
9. Uveitis (UV): treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. There are an estimated 475,350 patients that could be treated with Hyrimoz in the United States. Source: Label from USFDA (Drugs@FDA). Link: label (fda.gov)
Acquisition date and acquisition price not applicable; Sandoz Inc. did not acquire the product. Sandoz Inc. provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Sandoz Inc. does not waive any rights that may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Sandoz Inc. or any of its affiliates now or in the future. Sandoz Inc., on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all Sandoz Inc.’s related information herein is confidential and proprietary commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that your company or organization maintain the confidentiality of this submission and of all Sandoz Inc.’s related information herein to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that your company or organization notify us of the request and afford us the opportunity to submit objections to disclosure. |
None |
| Sandoz Inc. |
61314053164 |
HYRIOZ 80+40MG 2KIT MP BI US |
Generic |
FDA |
2023-07-05 |
9864.7600 |
Sandoz’s marketing plan for the introduction of Hyrimoz will focus on educating health care professionals (HCPs) and patients (consumers) about the benefit of biosimilars and the approved use of Hyrimoz. Sandoz does not plan to do any direct-to-consumer media advertisements on TV, in magazines, radio, billboards or blogs. Consumer engagement will include our patient website, patient education brochures and emails for those patients that opt into communications and enroll in patient support. Sandoz will offer a patient transition program to patients that transition from Humira to Hyrimoz. HCP engagement will include the HCP website, printed resources, email blasts and other digital resources in line with the Hyrimoz prescribing information. We will provide samples to physician offices but will not provide gifts or sponsor continuing education programs for HCPs. The WAC is priced lower than the WAC of the reference product. |
None |
407 |
None |
None |
None |
None |
None |
None |
Hyrimoz is a tumor necrosis factor (TNF) blocker indicated for 9 disease states :
1. Rheumatoid Arthritis (RA): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA.
2. Juvenile Idiopathic Arthritis (JIA): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older.
3. Psoriatic Arthritis (PsA): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA.
4. Ankylosing Spondylitis (AS): reducing signs and symptoms in adult patients with active AS.
5. Crohn’s Disease (CD): treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.
6. Ulcerative Colitis (UC): treatment of moderately to severely active ulcerative colitis in adults and pediatric patients 5 years of age and older. Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers.
7. Plaque Psoriasis (Ps): treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.
8. Hidradenitis Suppurativa (HS): treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older.
9. Uveitis (UV): treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. There are an estimated 475,350 patients that could be treated with Hyrimoz in the United States. Source: Label from USFDA (Drugs@FDA). Link: label (fda.gov)
Acquisition date and acquisition price not applicable; Sandoz Inc. did not acquire the product. Sandoz Inc. provides this report consistent with its understanding and interpretation of California SB 17 Chapter 603 Chapter 9 § 127681 and its provisions. In providing this report, Sandoz Inc. does not waive any rights that may have at law or in equity with respect to the applicability, interpretation, or application of California SB 17 Chapter 603 Chapter 9 § 127681 as it may relate to Sandoz Inc. or any of its affiliates now or in the future. Sandoz Inc., on behalf of itself and affiliates, expressly reserves all such rights. We believe that this submission and of all Sandoz Inc.’s related information herein is confidential and proprietary commercial or financial information not subject to disclosure, including under the California Public Records Act (Government Code Section 6250 et seq.) and applicable laws pertaining to trade secrets. We request that your company or organization maintain the confidentiality of this submission and of all Sandoz Inc.’s related information herein to the maximum extent permitted by law. When any of this information is requested, whether under the California Public Records Act (Government Code Section 6250 et seq.) or otherwise, we request that your company or organization notify us of the request and afford us the opportunity to submit objections to disclosure. |
None |
| Sanofi |
71104098101 |
ALTUVIIIO™, efanesoctocog alfa, [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl], 1000 IU nominally, Single Dose Vial in a Kit |
Brand |
FDA |
2023-03-27 |
5.1100 |
In the US, marketing initiatives are expected to include print and digital media, engagement at scientific meetings attended by HCPs most likely to manage patients with hemophilia A patients, materials to be used by sales representatives to educate about hemophilia A and to share information on ALTUVIIIO with HCPs, and materials to educate patients about hemophilia A and ALTUVIIIO. Direct to Consumer (DTC) outreach for ALTUVIIIO will include printed materials, search, website, email, and online ad placements. DTC initiatives are not expected to include any TV, radio or national magazine advertising.
Ex-US, marketing initiatives are expected to include print and digital media, engagement at scientific meetings attended by HCPs most likely to manage patients with Hemophilia A, materials to be used by sales representatives to share information on ALTUVIIIO with HCPs
At Sanofi, we work passionately to prevent, treat, and cure illness and disease, understand and solve health care needs of people across the world, and transform the practice of medicine. Sanofi has a longstanding commitment to promote health care systems that make our treatments accessible and affordable to patients in need.
Sanofi understands and shares concerns about the affordability of medicines for patients while also recognizing that we are only one of many stakeholders in the health care system. In order to maintain an environment that will continue to bring new health care solutions to patients, we must encourage a transition to a value-driven health care system that provides incentives for the highest-quality care. This evolution will enable both affordable access to treatment and continued investment in medical innovation. Sanofi is committed to helping address this challenge. While many factors, including decisions affecting patient out-of-pocket spending and insurance coverage, are controlled by other stakeholders in the health care system, we believe we have a responsibility to be a leader in solving issues of patient access and system viability. For our part, we price our medicines according to their value, while contributing to broader solutions that improve patient outcomes and support affordability within the U.S. health care system.
When we set the price of a new medicine, we hold ourselves to a rigorous and structured process that includes consultation with external stakeholders and considers a holistic assessment of value through clinical, economic and societal lens; similar treatment options, affordability and unique factors specific to the medicine at time of launch (i.e., longer-term outcome studies, sophisticated patient support tools, etc.). |
None |
25000 |
1 |
1 |
None |
None |
None |
None |
Hemophilia A, also called factor VIII (8) deficiency or classic hemophilia, is a genetic disorder caused by missing or defective factor VIII (FVIII), a clotting protein. Although it is passed down from parents to children, about 1/3 of cases found have no previous family history. Hemophilia is an inherited bleeding disorder primarily affecting males—but females can also have hemophilia. Patients are classified as mild, moderate, or severe hemophilia. More than half of people diagnosed with hemophilia A have the severe form. Hemophilia A is four times as common as hemophilia B. Hemophilia affects all races and ethnic groups.
ALTUVIIIO is approved for the treatment of Hemophilia A patients regardless of gender, age, or disease severity, and it is indicated for use for prophylaxis, on-demand, and perioperative use. Currently, there are an estimated 25,000 patients in the US with hemophilia A across all severity levels, including men and women with the rare blood disorder. Approximately 13,000 are treated and have the potential to be prescribed ALTUVIIIO. |
None |
| Sanofi |
71104098201 |
ALTUVIIIO™, efanesoctocog alfa, [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl], 2000 IU nominally, Single Dose Vial in a Kit |
Brand |
FDA |
2023-03-27 |
5.1100 |
In the US, marketing initiatives are expected to include print and digital media, engagement at scientific meetings attended by HCPs most likely to manage patients with hemophilia A patients, materials to be used by sales representatives to educate about hemophilia A and to share information on ALTUVIIIO with HCPs, and materials to educate patients about hemophilia A and ALTUVIIIO. Direct to Consumer (DTC) outreach for ALTUVIIIO will include printed materials, search, website, email, and online ad placements. DTC initiatives are not expected to include any TV, radio or national magazine advertising.
Ex-US, marketing initiatives are expected to include print and digital media, engagement at scientific meetings attended by HCPs most likely to manage patients with Hemophilia A, materials to be used by sales representatives to share information on ALTUVIIIO with HCPs
At Sanofi, we work passionately to prevent, treat, and cure illness and disease, understand and solve health care needs of people across the world, and transform the practice of medicine. Sanofi has a longstanding commitment to promote health care systems that make our treatments accessible and affordable to patients in need.
Sanofi understands and shares concerns about the affordability of medicines for patients while also recognizing that we are only one of many stakeholders in the health care system. In order to maintain an environment that will continue to bring new health care solutions to patients, we must encourage a transition to a value-driven health care system that provides incentives for the highest-quality care. This evolution will enable both affordable access to treatment and continued investment in medical innovation. Sanofi is committed to helping address this challenge. While many factors, including decisions affecting patient out-of-pocket spending and insurance coverage, are controlled by other stakeholders in the health care system, we believe we have a responsibility to be a leader in solving issues of patient access and system viability. For our part, we price our medicines according to their value, while contributing to broader solutions that improve patient outcomes and support affordability within the U.S. health care system.
When we set the price of a new medicine, we hold ourselves to a rigorous and structured process that includes consultation with external stakeholders and considers a holistic assessment of value through clinical, economic and societal lens; similar treatment options, affordability and unique factors specific to the medicine at time of launch (i.e., longer-term outcome studies, sophisticated patient support tools, etc.). |
None |
25000 |
1 |
1 |
None |
None |
None |
None |
Hemophilia A, also called factor VIII (8) deficiency or classic hemophilia, is a genetic disorder caused by missing or defective factor VIII (FVIII), a clotting protein. Although it is passed down from parents to children, about 1/3 of cases found have no previous family history. Hemophilia is an inherited bleeding disorder primarily affecting males—but females can also have hemophilia. Patients are classified as mild, moderate, or severe hemophilia. More than half of people diagnosed with hemophilia A have the severe form. Hemophilia A is four times as common as hemophilia B. Hemophilia affects all races and ethnic groups.
ALTUVIIIO is approved for the treatment of Hemophilia A patients regardless of gender, age, or disease severity, and it is indicated for use for prophylaxis, on-demand, and perioperative use. Currently, there are an estimated 25,000 patients in the US with hemophilia A across all severity levels, including men and women with the rare blood disorder. Approximately 13,000 are treated and have the potential to be prescribed ALTUVIIIO. |
None |
| Sanofi |
71104097801 |
ALTUVIIIO™, efanesoctocog alfa, [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl], 250 IU nominally, Single Dose Vial in a Kit |
Brand |
FDA |
2023-03-27 |
5.1100 |
In the US, marketing initiatives are expected to include print and digital media, engagement at scientific meetings attended by HCPs most likely to manage patients with hemophilia A patients, materials to be used by sales representatives to educate about hemophilia A and to share information on ALTUVIIIO with HCPs, and materials to educate patients about hemophilia A and ALTUVIIIO. Direct to Consumer (DTC) outreach for ALTUVIIIO will include printed materials, search, website, email, and online ad placements. DTC initiatives are not expected to include any TV, radio or national magazine advertising.
Ex-US, marketing initiatives are expected to include print and digital media, engagement at scientific meetings attended by HCPs most likely to manage patients with Hemophilia A, materials to be used by sales representatives to share information on ALTUVIIIO with HCPs
At Sanofi, we work passionately to prevent, treat, and cure illness and disease, understand and solve health care needs of people across the world, and transform the practice of medicine. Sanofi has a longstanding commitment to promote health care systems that make our treatments accessible and affordable to patients in need.
Sanofi understands and shares concerns about the affordability of medicines for patients while also recognizing that we are only one of many stakeholders in the health care system. In order to maintain an environment that will continue to bring new health care solutions to patients, we must encourage a transition to a value-driven health care system that provides incentives for the highest-quality care. This evolution will enable both affordable access to treatment and continued investment in medical innovation. Sanofi is committed to helping address this challenge. While many factors, including decisions affecting patient out-of-pocket spending and insurance coverage, are controlled by other stakeholders in the health care system, we believe we have a responsibility to be a leader in solving issues of patient access and system viability. For our part, we price our medicines according to their value, while contributing to broader solutions that improve patient outcomes and support affordability within the U.S. health care system.
When we set the price of a new medicine, we hold ourselves to a rigorous and structured process that includes consultation with external stakeholders and considers a holistic assessment of value through clinical, economic and societal lens; similar treatment options, affordability and unique factors specific to the medicine at time of launch (i.e., longer-term outcome studies, sophisticated patient support tools, etc.). |
None |
25000 |
1 |
1 |
None |
None |
None |
None |
Hemophilia A, also called factor VIII (8) deficiency or classic hemophilia, is a genetic disorder caused by missing or defective factor VIII (FVIII), a clotting protein. Although it is passed down from parents to children, about 1/3 of cases found have no previous family history. Hemophilia is an inherited bleeding disorder primarily affecting males—but females can also have hemophilia. Patients are classified as mild, moderate, or severe hemophilia. More than half of people diagnosed with hemophilia A have the severe form. Hemophilia A is four times as common as hemophilia B. Hemophilia affects all races and ethnic groups.
ALTUVIIIO is approved for the treatment of Hemophilia A patients regardless of gender, age, or disease severity, and it is indicated for use for prophylaxis, on-demand, and perioperative use. Currently, there are an estimated 25,000 patients in the US with hemophilia A across all severity levels, including men and women with the rare blood disorder. Approximately 13,000 are treated and have the potential to be prescribed ALTUVIIIO. |
None |
| Sanofi |
71104098301 |
ALTUVIIIO™, efanesoctocog alfa, [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl], 3000 IU nominally, Single Dose Vial in a Kit |
Brand |
FDA |
2023-03-27 |
5.1100 |
In the US, marketing initiatives are expected to include print and digital media, engagement at scientific meetings attended by HCPs most likely to manage patients with hemophilia A patients, materials to be used by sales representatives to educate about hemophilia A and to share information on ALTUVIIIO with HCPs, and materials to educate patients about hemophilia A and ALTUVIIIO. Direct to Consumer (DTC) outreach for ALTUVIIIO will include printed materials, search, website, email, and online ad placements. DTC initiatives are not expected to include any TV, radio or national magazine advertising.
Ex-US, marketing initiatives are expected to include print and digital media, engagement at scientific meetings attended by HCPs most likely to manage patients with Hemophilia A, materials to be used by sales representatives to share information on ALTUVIIIO with HCPs
At Sanofi, we work passionately to prevent, treat, and cure illness and disease, understand and solve health care needs of people across the world, and transform the practice of medicine. Sanofi has a longstanding commitment to promote health care systems that make our treatments accessible and affordable to patients in need.
Sanofi understands and shares concerns about the affordability of medicines for patients while also recognizing that we are only one of many stakeholders in the health care system. In order to maintain an environment that will continue to bring new health care solutions to patients, we must encourage a transition to a value-driven health care system that provides incentives for the highest-quality care. This evolution will enable both affordable access to treatment and continued investment in medical innovation. Sanofi is committed to helping address this challenge. While many factors, including decisions affecting patient out-of-pocket spending and insurance coverage, are controlled by other stakeholders in the health care system, we believe we have a responsibility to be a leader in solving issues of patient access and system viability. For our part, we price our medicines according to their value, while contributing to broader solutions that improve patient outcomes and support affordability within the U.S. health care system.
When we set the price of a new medicine, we hold ourselves to a rigorous and structured process that includes consultation with external stakeholders and considers a holistic assessment of value through clinical, economic and societal lens; similar treatment options, affordability and unique factors specific to the medicine at time of launch (i.e., longer-term outcome studies, sophisticated patient support tools, etc.). |
None |
25000 |
1 |
1 |
None |
None |
None |
None |
Hemophilia A, also called factor VIII (8) deficiency or classic hemophilia, is a genetic disorder caused by missing or defective factor VIII (FVIII), a clotting protein. Although it is passed down from parents to children, about 1/3 of cases found have no previous family history. Hemophilia is an inherited bleeding disorder primarily affecting males—but females can also have hemophilia. Patients are classified as mild, moderate, or severe hemophilia. More than half of people diagnosed with hemophilia A have the severe form. Hemophilia A is four times as common as hemophilia B. Hemophilia affects all races and ethnic groups.
ALTUVIIIO is approved for the treatment of Hemophilia A patients regardless of gender, age, or disease severity, and it is indicated for use for prophylaxis, on-demand, and perioperative use. Currently, there are an estimated 25,000 patients in the US with hemophilia A across all severity levels, including men and women with the rare blood disorder. Approximately 13,000 are treated and have the potential to be prescribed ALTUVIIIO. |
None |
| Sanofi |
71104098401 |
ALTUVIIIO™, efanesoctocog alfa, [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl], 4000 IU nominally, Single Dose Vial in a Kit |
Brand |
FDA |
2023-03-27 |
5.1100 |
In the US, marketing initiatives are expected to include print and digital media, engagement at scientific meetings attended by HCPs most likely to manage patients with hemophilia A patients, materials to be used by sales representatives to educate about hemophilia A and to share information on ALTUVIIIO with HCPs, and materials to educate patients about hemophilia A and ALTUVIIIO. Direct to Consumer (DTC) outreach for ALTUVIIIO will include printed materials, search, website, email, and online ad placements. DTC initiatives are not expected to include any TV, radio or national magazine advertising.
Ex-US, marketing initiatives are expected to include print and digital media, engagement at scientific meetings attended by HCPs most likely to manage patients with Hemophilia A, materials to be used by sales representatives to share information on ALTUVIIIO with HCPs
At Sanofi, we work passionately to prevent, treat, and cure illness and disease, understand and solve health care needs of people across the world, and transform the practice of medicine. Sanofi has a longstanding commitment to promote health care systems that make our treatments accessible and affordable to patients in need.
Sanofi understands and shares concerns about the affordability of medicines for patients while also recognizing that we are only one of many stakeholders in the health care system. In order to maintain an environment that will continue to bring new health care solutions to patients, we must encourage a transition to a value-driven health care system that provides incentives for the highest-quality care. This evolution will enable both affordable access to treatment and continued investment in medical innovation. Sanofi is committed to helping address this challenge. While many factors, including decisions affecting patient out-of-pocket spending and insurance coverage, are controlled by other stakeholders in the health care system, we believe we have a responsibility to be a leader in solving issues of patient access and system viability. For our part, we price our medicines according to their value, while contributing to broader solutions that improve patient outcomes and support affordability within the U.S. health care system.
When we set the price of a new medicine, we hold ourselves to a rigorous and structured process that includes consultation with external stakeholders and considers a holistic assessment of value through clinical, economic and societal lens; similar treatment options, affordability and unique factors specific to the medicine at time of launch (i.e., longer-term outcome studies, sophisticated patient support tools, etc.). |
None |
25000 |
1 |
1 |
None |
None |
None |
None |
Hemophilia A, also called factor VIII (8) deficiency or classic hemophilia, is a genetic disorder caused by missing or defective factor VIII (FVIII), a clotting protein. Although it is passed down from parents to children, about 1/3 of cases found have no previous family history. Hemophilia is an inherited bleeding disorder primarily affecting males—but females can also have hemophilia. Patients are classified as mild, moderate, or severe hemophilia. More than half of people diagnosed with hemophilia A have the severe form. Hemophilia A is four times as common as hemophilia B. Hemophilia affects all races and ethnic groups.
ALTUVIIIO is approved for the treatment of Hemophilia A patients regardless of gender, age, or disease severity, and it is indicated for use for prophylaxis, on-demand, and perioperative use. Currently, there are an estimated 25,000 patients in the US with hemophilia A across all severity levels, including men and women with the rare blood disorder. Approximately 13,000 are treated and have the potential to be prescribed ALTUVIIIO. |
None |
| Sanofi |
71104097901 |
ALTUVIIIO™, efanesoctocog alfa, [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl], 500 IU nominally, Single Dose Vial in a Kit |
Brand |
FDA |
2023-03-27 |
5.1100 |
In the US, marketing initiatives are expected to include print and digital media, engagement at scientific meetings attended by HCPs most likely to manage patients with hemophilia A patients, materials to be used by sales representatives to educate about hemophilia A and to share information on ALTUVIIIO with HCPs, and materials to educate patients about hemophilia A and ALTUVIIIO. Direct to Consumer (DTC) outreach for ALTUVIIIO will include printed materials, search, website, email, and online ad placements. DTC initiatives are not expected to include any TV, radio or national magazine advertising.
Ex-US, marketing initiatives are expected to include print and digital media, engagement at scientific meetings attended by HCPs most likely to manage patients with Hemophilia A, materials to be used by sales representatives to share information on ALTUVIIIO with HCPs
At Sanofi, we work passionately to prevent, treat, and cure illness and disease, understand and solve health care needs of people across the world, and transform the practice of medicine. Sanofi has a longstanding commitment to promote health care systems that make our treatments accessible and affordable to patients in need.
Sanofi understands and shares concerns about the affordability of medicines for patients while also recognizing that we are only one of many stakeholders in the health care system. In order to maintain an environment that will continue to bring new health care solutions to patients, we must encourage a transition to a value-driven health care system that provides incentives for the highest-quality care. This evolution will enable both affordable access to treatment and continued investment in medical innovation. Sanofi is committed to helping address this challenge. While many factors, including decisions affecting patient out-of-pocket spending and insurance coverage, are controlled by other stakeholders in the health care system, we believe we have a responsibility to be a leader in solving issues of patient access and system viability. For our part, we price our medicines according to their value, while contributing to broader solutions that improve patient outcomes and support affordability within the U.S. health care system.
When we set the price of a new medicine, we hold ourselves to a rigorous and structured process that includes consultation with external stakeholders and considers a holistic assessment of value through clinical, economic and societal lens; similar treatment options, affordability and unique factors specific to the medicine at time of launch (i.e., longer-term outcome studies, sophisticated patient support tools, etc.). |
None |
25000 |
1 |
1 |
None |
None |
None |
None |
Hemophilia A, also called factor VIII (8) deficiency or classic hemophilia, is a genetic disorder caused by missing or defective factor VIII (FVIII), a clotting protein. Although it is passed down from parents to children, about 1/3 of cases found have no previous family history. Hemophilia is an inherited bleeding disorder primarily affecting males—but females can also have hemophilia. Patients are classified as mild, moderate, or severe hemophilia. More than half of people diagnosed with hemophilia A have the severe form. Hemophilia A is four times as common as hemophilia B. Hemophilia affects all races and ethnic groups.
ALTUVIIIO is approved for the treatment of Hemophilia A patients regardless of gender, age, or disease severity, and it is indicated for use for prophylaxis, on-demand, and perioperative use. Currently, there are an estimated 25,000 patients in the US with hemophilia A across all severity levels, including men and women with the rare blood disorder. Approximately 13,000 are treated and have the potential to be prescribed ALTUVIIIO. |
None |
| Sarepta Therapeutics Inc |
60923050110 |
Delandistrogene Moxeparvovec 10 Vial 100 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923050211 |
Delandistrogene Moxeparvovec 11 Vial 110 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923050312 |
Delandistrogene Moxeparvovec 12 Vial 120 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923050413 |
Delandistrogene Moxeparvovec 13 Vial 130 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923050514 |
Delandistrogene Moxeparvovec 14 Vial 140 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923050615 |
Delandistrogene Moxeparvovec 15 Vial 150 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923050716 |
Delandistrogene Moxeparvovec 16 Vial 160 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923050817 |
Delandistrogene Moxeparvovec 17 Vial 170 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923050918 |
Delandistrogene Moxeparvovec 18 Vial 180 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923051019 |
Delandistrogene Moxeparvovec 19 Vial 190 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923051120 |
Delandistrogene Moxeparvovec 20 Vial 200 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923051221 |
Delandistrogene Moxeparvovec 21 Vial 210 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923051322 |
Delandistrogene Moxeparvovec 22 Vial 220 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923051423 |
Delandistrogene Moxeparvovec 23 Vial 230 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923051524 |
Delandistrogene Moxeparvovec 24 Vial 240 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923051625 |
Delandistrogene Moxeparvovec 25 Vial 250 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923051726 |
Delandistrogene Moxeparvovec 26 Vial 260 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923051827 |
Delandistrogene Moxeparvovec 27 Vial 270 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923051928 |
Delandistrogene Moxeparvovec 28 Vial 280 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923052029 |
Delandistrogene Moxeparvovec 29 Vial 290 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923052130 |
Delandistrogene Moxeparvovec 30 Vial 300 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923052231 |
Delandistrogene Moxeparvovec 31 Vial 310 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923052332 |
Delandistrogene Moxeparvovec 32 Vial 320 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923052433 |
Delandistrogene Moxeparvovec 33 Vial 330 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923052534 |
Delandistrogene Moxeparvovec 34 Vial 340 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923052635 |
Delandistrogene Moxeparvovec 35 Vial 350 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923052736 |
Delandistrogene Moxeparvovec 36 Vial 360 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923052837 |
Delandistrogene Moxeparvovec 37 Vial 370 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923052938 |
Delandistrogene Moxeparvovec 38 Vial 380 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923053039 |
Delandistrogene Moxeparvovec 39 Vial 390 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923053140 |
Delandistrogene Moxeparvovec 40 Vial 400 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923053241 |
Delandistrogene Moxeparvovec 41 Vial 410 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923053342 |
Delandistrogene Moxeparvovec 42 Vial 420 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923053443 |
Delandistrogene Moxeparvovec 43 Vial 430 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923053544 |
Delandistrogene Moxeparvovec 44 Vial 440 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923053645 |
Delandistrogene Moxeparvovec 45 Vial 450 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923053746 |
Delandistrogene Moxeparvovec 46 Vial 460 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923053847 |
Delandistrogene Moxeparvovec 47 Vial 470 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923053948 |
Delandistrogene Moxeparvovec 48 Vial 480 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923054049 |
Delandistrogene Moxeparvovec 49 Vial 490 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923054150 |
Delandistrogene Moxeparvovec 50 Vial 500 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923054251 |
Delandistrogene Moxeparvovec 51 Vial 510 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923054352 |
Delandistrogene Moxeparvovec 52 Vial 520 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923054453 |
Delandistrogene Moxeparvovec 53 Vial 530 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923054554 |
Delandistrogene Moxeparvovec 54 Vial 540 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923054655 |
Delandistrogene Moxeparvovec 55 Vial 550 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923054756 |
Delandistrogene Moxeparvovec 56 Vial 560 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923054857 |
Delandistrogene Moxeparvovec 57 Vial 570 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923054958 |
Delandistrogene Moxeparvovec 58 Vial 580 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923055059 |
Delandistrogene Moxeparvovec 59 Vial 590 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923055160 |
Delandistrogene Moxeparvovec 60 Vial 600 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923055261 |
Delandistrogene Moxeparvovec 61 Vial 610 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923055362 |
Delandistrogene Moxeparvovec 62 Vial 620 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923055463 |
Delandistrogene Moxeparvovec 63 Vial 630 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923055564 |
Delandistrogene Moxeparvovec 64 Vial 640 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923055665 |
Delandistrogene Moxeparvovec 65 Vial 650 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923055766 |
Delandistrogene Moxeparvovec 66 Vial 660 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923055867 |
Delandistrogene Moxeparvovec 67 Vial 670 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923055968 |
Delandistrogene Moxeparvovec 68 Vial 680 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923056069 |
Delandistrogene Moxeparvovec 69 Vial 690 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Sarepta Therapeutics Inc |
60923056170 |
Delandistrogene Moxeparvovec 70 Vial 700 ML Kit |
Brand |
FDA |
2023-06-22 |
3200000.0000 |
Sarepta is committed to responsibly pricing our ground breaking gene therapy, and more information can be found in the following assessment: https://www.tandfonline.com/doi/full/10.1080/20016689.2023.2216518
With regards to marketing and pricing plans beyond the assessment, Sarepta is limiting further response to information that is not in the public domain or publicly available. |
None |
1 |
None |
1 |
None |
None |
None |
None |
Response to "Estimated Number of Patients": Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. (Source: National Institutes of Health, Genetics Home Reference, Duchenne and Becker muscular dystrophy, available at https://ghr.nlm.nih.gov/condition/duchenne-and-becker-muscular-dystrophy; accessed December 2019.) Patients with a 45 mutation represent 8 percent of those with Duchenne. (Source: Aartsma-Rus A, Fokkema I, Verschuuren J, et al. Hum Mutat. 2009;30:293-299.) Elevidys is not an acquired product |
None |
| Shorla Oncology |
81927011106 |
NELARABINE (NELARABINE) 250MG/50ML (5MG/ML) 6 x 50 ML VIAL |
Generic |
FDA |
2023-05-16 |
3960.0000 |
Nelarabine is a generic physician administered oncology product. Shorla Oncology will be marketing the product to pharmacists and oncologists and will be pricing the product at parity to the market/competitors |
None |
555 |
None |
1 |
None |
None |
None |
None |
None |
None |
| Shorla Oncology |
81927020401 |
JYLAMVO ORAL SOLUTION 1 BOTTLE 60 ML 120 MG |
Brand |
FDA |
2023-12-18 |
876.4700 |
Jylamvo is a branded oral liquid formulation of methtrexate for adult patients with rheumatoid and oncologic diseases who have difficulty swallowing pills. It will be marketed as an alternative to compounding, pill splitting and pill crushing. Shorla Oncology will be marketing the product to pharmacists, rheumatologists and oncologists through a virtual sales team. |
None |
29900 |
None |
None |
None |
None |
None |
None |
None |
None |
| Slayback Pharma LLC |
71225014001 |
Baclofen Oral Suspension, 25mg/5mL, 250 mL in one bottle in one carton. |
Generic |
FDA |
2023-06-28 |
1361.2300 |
None |
1 |
2600 |
None |
None |
None |
None |
None |
None |
This is a newly approved drug in production. The first lots should be ready for market in the coming days or within two weeks. This was not an acquired drug. The total number of monthly patients has been estimated as we are not sure as to the amount of sales we will have the first year and competition is strong as there are more that 100 manufacturers with labeled Baclofen vying for market share. |
None |
| Somerset Pharma LLC |
70069072820 |
Calcium Gluconate Injection USP, 10,000 mg/100 mL |
Generic |
FDA |
2023-10-20 |
1078.2000 |
None |
1 |
75527 |
None |
None |
None |
None |
None |
None |
This product is being marketed in the generic, multisource space. This product was not acquired and was developed in house. |
None |
| Somerset Pharma LLC |
70069072725 |
Calcium Gluconate Injection, USP 5,000mg/50mL |
Generic |
FDA |
2023-10-20 |
673.5000 |
None |
1 |
61790 |
None |
None |
None |
None |
None |
None |
This product is being marketed in the generic, multisource space. This product was not acquired and was developed in house. |
None |
| SpringWorks Therapeutics |
82448005018 |
OGSIVEO (Nirogacestat) 50mg tablets, 180-ct bottle |
Brand |
FDA |
2023-12-04 |
29000.0000 |
Desmoid tumors are a rare, devastating disease, with a potentially significant burden of illness on patients. OGSIVEOTM (nirogacestat) is the first and only FDA-approved treatment indicated for adult patients with progressing desmoid tumors who require systemic treatment. Patients afflicted with desmoid tumors often have significant unmet need. OGSIVEO will be marketed to appropriate healthcare professionals in both community oncology and sarcoma centers of excellence in the U.S., as well as adult patients in the U.S. with desmoid tumors. General marketing efforts will be focused on highlighting the approved indication, efficacy, safety and value that OGSIVEO may deliver to appropriate patients in need. Specific marketing plans used to launch the drug in the U.S. include, without limitation, use of print and digital media, patient and HCP websites, opt in email communications, media advertisements to both healthcare providers and patients on platforms such as social media and other web-based mediums, professional detailing to healthcare providers, and conference events, seminars and speaker programs. Patient support programs will also be offered to facilitate access to OGSIVEO for eligible patients who have been prescribed OGSIVEO, but these programs are not considered marketing or promotional activities.
With respect to its pricing plans for OGSIVEO in the U.S., SpringWorks conducted extensive qualitative and quantitative market research and analysis of several factors, including unmet medical need, disease severity, and patient burden of illness in this orphan population. Additionally, SpringWorks assessed current market pricing for comparable orphan rare disease and oncology drugs, which included broad-based physician, payer and population health decision maker feedback. Additional financial and non-financial factors were considered in establishing the wholesale acquisition cost for OGSIVEO, including: the unique clinical value that OGSIVEO offers as the first and only FDA-approved gamma secretase inhibitor indicated for adult patients with progressing desmoid tumors who require systemic treatment; the safety and efficacy profile of the drug; patient access considerations, including the development and implementation of the SpringWorks CareConnections patient support program to support U.S. patients on their treatment journey with OGSIVEO; preclinical and ongoing clinical trials for the drug; anticipated discounts and other fees to be negotiated with supply chain partners, including wholesalers, specialty pharmacies, and group purchasing organizations; anticipated discounts, rebates and fees to various government programs; manufacturing and marketing costs; and past and ongoing investments in R&D (including resources, infrastructure and organization) to both support and build on the existing portfolio and develop new and innovative therapies for other rare indications.
SpringWorks does not currently market or sell OGSIVEO outside the U.S. |
None |
1311 |
1 |
1 |
2017-08-18 |
232500000.0000 |
None |
In August 2017, SpringWorks entered into a license agreement with Pfizer, pursuant to which we acquired exclusive (including as to Pfizer) worldwide sublicensable rights to research, develop and manufacture nirogacestat for the treatment, diagnosis and prevention of all diseases and commercialize nirogacestat for the treatment, diagnosis and prevention of all diseases other than Alzheimer’s disease, breast cancer and prostate cancer. Pursuant to the license agreement, SpringWorks is required to pay Pfizer up to an aggregate of $232.5 million upon achievement of certain commercial milestone events, and will pay Pfizer tiered royalties on sales of nirogacestat at percentages ranging from the mid-single digits to the low 20s, that may be subject to deductions for expiration of valid claims, amounts due under third-party licenses and generic competition. |
None |
None |
| Stemline Therapeutics |
72187010203 |
ORDERDU 345 MG tablet, 30 ct |
Brand |
FDA |
2023-02-03 |
21369.0000 |
When pricing Ordersu, Stemline considered a variety of factors, including the benefit to the patients, patient assistance programs, reinvestment to support lifecycle development of the compound, as well as development of new therapies, supply chain and other factors. Orserdu is the first oral estrogen receptor antagonist (commonly referred to as a SERD) and the first FDA approved therapy for appropriate mBC patients with ESR1 mutations. |
None |
13000 |
None |
1 |
2020-07-23 |
30000000.0000 |
None |
Stemline's parent company, the Menarini Group, licensed Ordersdu from Radius Health, Inc. with an upfront payment of $30 million and potential additional payments of up to $320 million based on the successful achievement of future development and sales milestones. Menarini Group will make tiered, low to mid-teen percentage royalty payments to Radius Health, Inc. on global net sales. |
In reference to Estimated Patients: While the overall incidence of ESR1 mutations is uncertain and reported only from small patient cohorts, it is estimated to affect ~13,000 patients with mBC in the US. We do not anticipate that Orserdu will be prescribed for that entire patient population. Orserdu is the first oral estrogen receptor antagonist (commonly referred to as a SERD) and the first FDA approved therapy for appropriate mBC patients with ESR1 mutations. Orserdu is an estrogen receptor agonist (commonly referred to as a SERD) indicated for the treatment of postmenopausal women or adult men with ER+/HER2- , ESR1 mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. Orserdu is the first FDA approved therapy for these patients. In 2022, the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) Program estimated that there would be 287,850 new cases of breast cancer diagnosed in the United States (US) (Siegel 2022). Approximately 6% of women have mBC at the time of their initial diagnosis and 20% to 40% of women initially diagnosed with localized or regional breast cancers will develop metastatic disease (SEER 2022; Vera-Llonch 2011). Approximately 68% of breast cancers diagnosed in women are ER/PR-positive and HER2- negative (SEER Cancer Stat Facts: Female Breast Cancer Subtypes. National Cancer Institute. Cyclin dependent kinase 4/6 (CDK4/6) inhibitors, combined with either an aromatase inhibitor or fulvestrant has since become the mainstay for first-line management of postmenopausal women with ER/PR-positive, HER2-negative mBC (Finn 2016b; Hortobagyi 2018; Goetz 2017; Tripathy 2018; Burstein 2021; NCCN v2.2023). However, tumors eventually develop endocrine resistance, often through the development of an estrogen receptor 1 gene (ESR1) mutation. Development of an acquired mutation in ESR1 is one of the key mechanisms of endocrine therapy resistance. The prevalence of ESR1 mutations in patients depends on prior duration and setting of endocrine therapy. ESR1 mutations have been reported in up to 39% of patients with ER/PR-positive, HER2 negative advanced or mBC who have received prior treatment with an aromatase inhibitor in the metastatic setting (Reinert 2017). |
None |
| Stemline Therapeutics |
72187010103 |
ORSERDU 86 MG tablets, 30 ct |
Brand |
FDA |
2023-02-03 |
7123.0000 |
When pricing Ordersu, Stemline considered a variety of factors, including the benefit to the patients, patient assistance programs, reinvestment to support lifecycle development of the compound, as well as development of new therapies, supply chain and other factors. Orserdu is the first oral estrogen receptor antagonist (commonly referred to as a SERD) and the first FDA approved therapy for appropriate mBC patients with ESR1 mutations. |
None |
13000 |
None |
1 |
2020-07-23 |
30000000.0000 |
None |
Stemline's parent company, the Menarini Group, licensed Ordersdu from Radius Health, Inc. with an upfront payment of $30 million and potential additional payments of up to $320 million based on the successful achievement of future development and sales milestones. Menarini Group will make tiered, low to mid-teen percentage royalty payments to Radius Health, Inc. on global net sales. |
In reference to Estimated Patients: While the overall incidence of ESR1 mutations is uncertain and reported only from small patient cohorts, it is estimated to affect ~13,000 patients with mBC in the US. We do not anticipate that Orserdu will be prescribed for that entire patient population. Orserdu is the first oral estrogen receptor antagonist (commonly referred to as a SERD) and the first FDA approved therapy for appropriate mBC patients with ESR1 mutations. Orserdu is an estrogen receptor agonist (commonly referred to as a SERD) indicated for the treatment of postmenopausal women or adult men with ER+/HER2- , ESR1 mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. Orserdu is the first FDA approved therapy for these patients. In 2022, the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) Program estimated that there would be 287,850 new cases of breast cancer diagnosed in the United States (US) (Siegel 2022). Approximately 6% of women have mBC at the time of their initial diagnosis and 20% to 40% of women initially diagnosed with localized or regional breast cancers will develop metastatic disease (SEER 2022; Vera-Llonch 2011). Approximately 68% of breast cancers diagnosed in women are ER/PR-positive and HER2- negative (SEER Cancer Stat Facts: Female Breast Cancer Subtypes. National Cancer Institute. Cyclin dependent kinase 4/6 (CDK4/6) inhibitors, combined with either an aromatase inhibitor or fulvestrant has since become the mainstay for first-line management of postmenopausal women with ER/PR-positive, HER2-negative mBC (Finn 2016b; Hortobagyi 2018; Goetz 2017; Tripathy 2018; Burstein 2021; NCCN v2.2023). However, tumors eventually develop endocrine resistance, often through the development of an estrogen receptor 1 gene (ESR1) mutation. Development of an acquired mutation in ESR1 is one of the key mechanisms of endocrine therapy resistance. The prevalence of ESR1 mutations in patients depends on prior duration and setting of endocrine therapy. ESR1 mutations have been reported in up to 39% of patients with ER/PR-positive, HER2 negative advanced or mBC who have received prior treatment with an aromatase inhibitor in the metastatic setting (Reinert 2017). |
None |
| SUN PHARMACEUTICALS |
63304004327 |
Lenalidomide Caps 10Mg 28ct |
Generic |
FDA |
2023-03-20 |
20157.3600 |
None |
1 |
235000 |
None |
None |
None |
None |
None |
None |
None |
None |
| SUN PHARMACEUTICALS |
63304004422 |
Lenalidomide Caps 15Mg 21ct |
Generic |
FDA |
2023-03-20 |
15118.0400 |
None |
1 |
235000 |
None |
None |
None |
None |
None |
None |
None |
None |
| SUN PHARMACEUTICALS |
63304004127 |
Lenalidomide Caps 2.5Mg 28ct |
Generic |
FDA |
2023-03-20 |
20157.3600 |
None |
1 |
235000 |
None |
None |
None |
None |
None |
None |
None |
None |
| SUN PHARMACEUTICALS |
63304004522 |
Lenalidomide Caps 20Mg 21ct |
Generic |
FDA |
2023-03-20 |
15118.0400 |
None |
1 |
235000 |
None |
None |
None |
None |
None |
None |
None |
None |
| SUN PHARMACEUTICALS |
63304004622 |
Lenalidomide Caps 25Mg 21ct |
Generic |
FDA |
2023-03-20 |
15118.0400 |
None |
1 |
235000 |
None |
None |
None |
None |
None |
None |
None |
None |
| SUN PHARMACEUTICALS |
63304004227 |
Lenalidomide Caps 5Mg 28ct |
Generic |
FDA |
2023-03-20 |
20157.3600 |
None |
1 |
235000 |
None |
None |
None |
None |
None |
None |
None |
None |
| SUN PHARMACEUTICALS |
57664004688 |
LISDEXAMFETAMINE DIMESYLATE CAPSULE 10mg |
Generic |
FDA |
2023-08-24 |
527.6000 |
As this is a generic pharmaceutical product, Sun does not engage in marketing activities typically attendant to branded products. There are no direct-to-customer marketing activities of any kind, and no promotion of the product to physicians or other healthcare providers. Sun utilized appropriate pricing planning based on current and predicted market conditions. We have discussions with potential customers to determine and agree upon pricing since there are multiple generic competitors within the market for this product. |
None |
1600000 |
None |
None |
None |
None |
None |
None |
None |
None |
| SUN PHARMACEUTICALS |
57664004788 |
LISDEXAMFETAMINE DIMESYLATE CAPSULE 20mg |
Generic |
FDA |
2023-08-24 |
527.6000 |
As this is a generic pharmaceutical product, Sun does not engage in marketing activities typically attendant to branded products. There are no direct-to-customer marketing activities of any kind, and no promotion of the product to physicians or other healthcare providers. Sun utilized appropriate pricing planning based on current and predicted market conditions. We have discussions with potential customers to determine and agree upon pricing since there are multiple generic competitors within the market for this product. |
None |
1600000 |
None |
None |
None |
None |
None |
None |
None |
None |
| SUN PHARMACEUTICALS |
57664004888 |
LISDEXAMFETAMINE DIMESYLATE CAPSULE 30mg |
Generic |
FDA |
2023-08-24 |
527.6000 |
As this is a generic pharmaceutical product, Sun does not engage in marketing activities typically attendant to branded products. There are no direct-to-customer marketing activities of any kind, and no promotion of the product to physicians or other healthcare providers. Sun utilized appropriate pricing planning based on current and predicted market conditions. We have discussions with potential customers to determine and agree upon pricing since there are multiple generic competitors within the market for this product. |
None |
1600000 |
None |
None |
None |
None |
None |
None |
None |
None |
| SUN PHARMACEUTICALS |
57664004988 |
LISDEXAMFETAMINE DIMESYLATE CAPSULE 40mg |
Generic |
FDA |
2023-08-24 |
527.6000 |
As this is a generic pharmaceutical product, Sun does not engage in marketing activities typically attendant to branded products. There are no direct-to-customer marketing activities of any kind, and no promotion of the product to physicians or other healthcare providers. Sun utilized appropriate pricing planning based on current and predicted market conditions. We have discussions with potential customers to determine and agree upon pricing since there are multiple generic competitors within the market for this product. |
None |
1600000 |
None |
None |
None |
None |
None |
None |
None |
None |
| SUN PHARMACEUTICALS |
57664005088 |
LISDEXAMFETAMINE DIMESYLATE CAPSULE 50mg |
Generic |
FDA |
2023-08-24 |
527.6000 |
As this is a generic pharmaceutical product, Sun does not engage in marketing activities typically attendant to branded products. There are no direct-to-customer marketing activities of any kind, and no promotion of the product to physicians or other healthcare providers. Sun utilized appropriate pricing planning based on current and predicted market conditions. We have discussions with potential customers to determine and agree upon pricing since there are multiple generic competitors within the market for this product. |
None |
1600000 |
None |
None |
None |
None |
None |
None |
None |
None |
| SUN PHARMACEUTICALS |
57664005188 |
LISDEXAMFETAMINE DIMESYLATE CAPSULE 60mg |
Generic |
FDA |
2023-08-24 |
527.6000 |
As this is a generic pharmaceutical product, Sun does not engage in marketing activities typically attendant to branded products. There are no direct-to-customer marketing activities of any kind, and no promotion of the product to physicians or other healthcare providers. Sun utilized appropriate pricing planning based on current and predicted market conditions. We have discussions with potential customers to determine and agree upon pricing since there are multiple generic competitors within the market for this product. |
None |
1600000 |
None |
None |
None |
None |
None |
None |
None |
None |
| SUN PHARMACEUTICALS |
57664005288 |
LISDEXAMFETAMINE DIMESYLATE CAPSULE 70mg |
Generic |
FDA |
2023-08-24 |
527.6000 |
As this is a generic pharmaceutical product, Sun does not engage in marketing activities typically attendant to branded products. There are no direct-to-customer marketing activities of any kind, and no promotion of the product to physicians or other healthcare providers. Sun utilized appropriate pricing planning based on current and predicted market conditions. We have discussions with potential customers to determine and agree upon pricing since there are multiple generic competitors within the market for this product. |
None |
1600000 |
None |
None |
None |
None |
None |
None |
None |
None |
| SUN PHARMACEUTICALS |
57664008388 |
LISDEXAMFETAMINE DIMESYLATE TAB CHEW 10mg |
Generic |
FDA |
2023-08-24 |
1107.9500 |
As this is a generic pharmaceutical product, Sun does not engage in marketing activities typically attendant to branded products. There are no direct-to-customer marketing activities of any kind, and no promotion of the product to physicians or other healthcare providers. Sun utilized appropriate pricing planning based on current and predicted market conditions. We have discussions with potential customers to determine and agree upon pricing since there are multiple generic competitors within the market for this product. |
None |
1600000 |
None |
None |
None |
None |
None |
None |
None |
None |
| SUN PHARMACEUTICALS |
57664008488 |
LISDEXAMFETAMINE DIMESYLATE TAB CHEW 20mg |
Generic |
FDA |
2023-08-24 |
1107.9500 |
As this is a generic pharmaceutical product, Sun does not engage in marketing activities typically attendant to branded products. There are no direct-to-customer marketing activities of any kind, and no promotion of the product to physicians or other healthcare providers. Sun utilized appropriate pricing planning based on current and predicted market conditions. We have discussions with potential customers to determine and agree upon pricing since there are multiple generic competitors within the market for this product. |
None |
1600000 |
None |
None |
None |
None |
None |
None |
None |
None |
| SUN PHARMACEUTICALS |
57664008588 |
LISDEXAMFETAMINE DIMESYLATE TAB CHEW 30mg |
Generic |
FDA |
2023-08-24 |
1107.9500 |
As this is a generic pharmaceutical product, Sun does not engage in marketing activities typically attendant to branded products. There are no direct-to-customer marketing activities of any kind, and no promotion of the product to physicians or other healthcare providers. Sun utilized appropriate pricing planning based on current and predicted market conditions. We have discussions with potential customers to determine and agree upon pricing since there are multiple generic competitors within the market for this product. |
None |
1600000 |
None |
None |
None |
None |
None |
None |
None |
None |
| SUN PHARMACEUTICALS |
57664008688 |
LISDEXAMFETAMINE DIMESYLATE TAB CHEW 40mg |
Generic |
FDA |
2023-08-24 |
1107.9500 |
As this is a generic pharmaceutical product, Sun does not engage in marketing activities typically attendant to branded products. There are no direct-to-customer marketing activities of any kind, and no promotion of the product to physicians or other healthcare providers. Sun utilized appropriate pricing planning based on current and predicted market conditions. We have discussions with potential customers to determine and agree upon pricing since there are multiple generic competitors within the market for this product. |
None |
1600000 |
None |
None |
None |
None |
None |
None |
None |
None |
| SUN PHARMACEUTICALS |
57664008788 |
LISDEXAMFETAMINE DIMESYLATE TAB CHEW 50mg |
Generic |
FDA |
2023-08-24 |
1107.9500 |
As this is a generic pharmaceutical product, Sun does not engage in marketing activities typically attendant to branded products. There are no direct-to-customer marketing activities of any kind, and no promotion of the product to physicians or other healthcare providers. Sun utilized appropriate pricing planning based on current and predicted market conditions. We have discussions with potential customers to determine and agree upon pricing since there are multiple generic competitors within the market for this product. |
None |
1600000 |
None |
None |
None |
None |
None |
None |
None |
None |
| SUN PHARMACEUTICALS |
57664008888 |
LISDEXAMFETAMINE DIMESYLATE TAB CHEW 60mg |
Generic |
FDA |
2023-08-24 |
1107.9500 |
As this is a generic pharmaceutical product, Sun does not engage in marketing activities typically attendant to branded products. There are no direct-to-customer marketing activities of any kind, and no promotion of the product to physicians or other healthcare providers. Sun utilized appropriate pricing planning based on current and predicted market conditions. We have discussions with potential customers to determine and agree upon pricing since there are multiple generic competitors within the market for this product. |
None |
1600000 |
None |
None |
None |
None |
None |
None |
None |
None |
| SUN PHARMACEUTICALS |
63304011613 |
Pazopanib Tablets 200mg 120ct |
Generic |
FDA |
2023-10-19 |
15021.1700 |
Pricing plan: Brand WAC minus 11%. As this is a generic pharmaceutical product, Sun does not engage in marketing activities typically attendant to branded products. There are no direct-to-customer marketing activities of any kind, and no promotion of the product to physicians or other healthcare providers. Sun utilized appropriate pricing planning based on current and predicted market conditions. We have discussions with potential customers to determine and agree upon pricing since there are multiple generic competitors within the market for this product. |
None |
628355 |
None |
None |
None |
None |
None |
None |
None |
None |