| Sagent Pharmaceuticals |
25021032401 |
Isoproterenol Hydrochloride Injection (0.2mg/ml, 1ml, 10x1ml) |
2025-03-14 |
1250.0000 |
Product is an off-patent generic injectable with multiple competitors. Plan is to be market competitive |
None |
28400 |
None |
None |
None |
None |
None |
None |
None |
None |
| Sagent Pharmaceuticals |
25021032405 |
Isoproterenol Hydrochloride Injection (0.2mg/ml, 5ml, 10x5ml) |
2025-03-18 |
1400.0000 |
Product is an off-patent generic injectable with multiple competitors. Plan is to be market competitive |
None |
86000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Sagent Pharmaceuticals |
25021032302 |
Procainamide Hydrochloride Injection (500mg/ml, 2ml, 10x2ml) |
2025-03-27 |
4500.0000 |
Product is an off-patent generic injectable with multiple competitors. Plan is to be market competitive |
None |
48140 |
None |
None |
None |
None |
None |
None |
None |
None |
| Sandoz Inc. |
61314032520 |
ADALIMUMAB 80MG/0.8ML 2LISY PE BI V1 US |
2025-01-15 |
2630.6000 |
Sandoz’s marketing plan for the introduction of Adalimumab will focus on educating health care professionals (HCPs) and patients (consumers) about the benefit of biosimilars and the approved use of Adalimumab. 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 Adalimumab. HCP engagement will include the HCP website, printed resources, email blasts and other digital resources in line with the Hyrimoz prescribing information. There is no additional marketing spend for this product and none planned for this product family. |
None |
519999 |
None |
None |
None |
None |
None |
None |
Adalimumab 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. Source: Label from USFDA (Drugs@FDA). Link below 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. |
00781352720 |
Edaravone 30MG/100ML 2LIBA US |
2025-01-30 |
1145.1800 |
Sandoz Inc. is contracting within the wholesaler and/or specialty pharmacy space. This is a generic drug and there is no actual or planned direct-to-consumer marketing or advertising for this product. The WAC is priced lower than the WAC of the reference product. |
None |
63 |
None |
None |
None |
None |
None |
None |
Amyotrophic Lateral Sclerosis (ALS): ALS is a progressive neurodegenerative disease that affects motor neurons in the brain and spinal cord, causing muscle weakness, severe disability, and eventually death. The condition affects approximately 15,000–21,000 people in the United States, according to the ALS Association. The average life expectancy of a person with ALS is about 2-5 years from the time of diagnosis, although some people can live with the disease for more than 5 years. Approximately 5000 people in the United States are diagnosed with ALS each year. There is an estimated 63 patients treated with Edaravone IV in the United States. Source : IQVIA, PIL (Drugs@FDA), Company Website
Acquistion date and Acquistion price not applicable as Sandoz did not acquire this 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. |
61314065494 |
PYZCHIVA 130MG/26ML 26ML LIVI US |
2025-02-24 |
1564.7800 |
Sandoz’s marketing plan for the introduction of Pyzchiva will focus on educating health care professionals (HCPs) and patients (consumers) about the benefit of biosimilars and the approved use of Pyzchiva. 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. HCP engagement will include the HCP website, printed resources, email blasts and other digital resources in line with the Pyzchiva prescribing information. The WAC is priced lower than the WAC of the reference product. |
None |
26019 |
None |
None |
None |
None |
None |
None |
Pychiva is a human interleukin-12 and -23 antagonist indicated for a numer of treatment in Adults with:
1. Moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy
2. Active psoriatic arthritis (PsA)
3. Moderately to severely active Crohn’s disease (CD)
4. Moderately to severely active ulcerative colitis
B. Pediatric patients 6 years and older with :
1. Moderate to severe plaque psoriasis, who are candidates for phototherapy or systemic therapy
2. Active psoriatic arthritis (PsA)
There is an estimated 140,685 patients treated with Pychiva in the United States.
Source: Label (Drug@FDA, USFDA)
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. |
61314065101 |
PYZCHIVA 45MG/0.5ML 0.5ML LISY US |
2025-02-24 |
2915.1500 |
Sandoz’s marketing plan for the introduction of Pyzchiva will focus on educating health care professionals (HCPs) and patients (consumers) about the benefit of biosimilars and the approved use of Pyzchiva. 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. HCP engagement will include the HCP website, printed resources, email blasts and other digital resources in line with the Pyzchiva prescribing information. The WAC is priced lower than the WAC of the reference product. |
None |
17096 |
None |
None |
None |
None |
None |
None |
Pychiva is a human interleukin-12 and -23 antagonist indicated for a numer of treatment in Adults with:
1. Moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy
2. Active psoriatic arthritis (PsA)
3. Moderately to severely active Crohn’s disease (CD)
4. Moderately to severely active ulcerative colitis
B. Pediatric patients 6 years and older with :
1. Moderate to severe plaque psoriasis, who are candidates for phototherapy or systemic therapy
2. Active psoriatic arthritis (PsA)
There is an estimated 140,685 patients treated with Pychiva in the United States.
Source: Label (Drug@FDA, USFDA)
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. |
61314065201 |
PYZCHIVA 90MG/1ML 1ML LISY US |
2025-02-24 |
5830.2900 |
Sandoz’s marketing plan for the introduction of Pyzchiva will focus on educating health care professionals (HCPs) and patients (consumers) about the benefit of biosimilars and the approved use of Pyzchiva. 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. HCP engagement will include the HCP website, printed resources, email blasts and other digital resources in line with the Pyzchiva prescribing information. The WAC is priced lower than the WAC of the reference product. |
None |
97570 |
None |
None |
None |
None |
None |
None |
Pychiva is a human interleukin-12 and -23 antagonist indicated for a numer of treatment in Adults with:
1. Moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy
2. Active psoriatic arthritis (PsA)
3. Moderately to severely active Crohn’s disease (CD)
4. Moderately to severely active ulcerative colitis
B. Pediatric patients 6 years and older with :
1. Moderate to severe plaque psoriasis, who are candidates for phototherapy or systemic therapy
2. Active psoriatic arthritis (PsA)
There is an estimated 140,685 patients treated with Pychiva in the United States.
Source: Label (Drug@FDA, USFDA)
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 |
| Solubiomix LLC |
73308043530 |
Ultramicrosize Griseofulvin, 165 mg, tablet, 30 count |
2025-03-03 |
992.1100 |
Sold through independent pharmacies |
None |
226 |
None |
None |
None |
None |
None |
None |
None |
None |
| SpringWorks Therapeutics |
82448013042 |
Gomekli (mirdametinib) 1mg Capsules, 42-ct bottle |
2025-02-18 |
8662.5000 |
Neurofibromatosis type 1 (NF1) is an incurable genetic condition affecting approximately 1 in 2500 newborns worldwide that is caused by a pathogenic variant in the NF1 tumor suppressor gene. Peripheral nerve sheath tumors called plexiform neurofibromas (PNs) are a common clinical manifestation of NF1. GOMEKLI (mirdametinib) is the first and only FDA-approved treatment for both adults and children 2 years of age and older with NF1 who have symptomatic PNs not amenable to complete resection. Despite advancements in NF1-PN treatment, unmet needs remain, and patients are in need of more options. GOMEKLI will be marketed to appropriate healthcare professionals in community neurology and oncology centers and NF1 centers of excellence in the U.S., as well as to appropriate patients in the U.S. with NF1-PNs. General marketing efforts will be focused on highlighting the approved indication, efficacy, safety and value that GOMEKLI 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, patients, payers and population health decision makers, on platforms such as social media and other web-based mediums, professional detailing to healthcare providers, payers, and conference events, seminars and speaker programs. Patient support programs will also be offered to facilitate access to GOMEKLI for eligible patients who have been prescribed GOMEKLI, but these programs are not considered marketing or promotional activities.
With respect to its pricing plans for GOMEKLI 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. Major financial and non-financial factors that influenced the decision to set the price of the drug at a level that exceeds the Medicare Part D threshold included: the unique clinical value that GOMEKLI offers as the first and only FDA-approved treatment for both adults and children 2 years of age and older with NF1 who have symptomatic PNs not amenable to complete resection; 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 GOMEKLI; preclinical and ongoing clinical trials for the drug; anticipated discounts and other fees to be negotiated with supply chain partners, including wholesalers, specialty pharmacies, PBMs 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 GOMEKLI outside the U.S. |
None |
4587 |
None |
1 |
2017-08-18 |
229800000.0000 |
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, manufacture and commercialize mirdametinib for the treatment of all diseases. Pursuant to the license agreement, SpringWorks is required to pay Pfizer up to an aggregate of $229.8 million upon achievement of certain commercial milestone events, and will pay Pfizer tiered royalties on sales of mirdametinib 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 |
| SpringWorks Therapeutics |
82448013442 |
Gomekli (mirdametinib) 1mg tablets, 42-ct bottle |
2025-02-18 |
8662.5000 |
Neurofibromatosis type 1 (NF1) is an incurable genetic condition affecting approximately 1 in 2500 newborns worldwide that is caused by a pathogenic variant in the NF1 tumor suppressor gene. Peripheral nerve sheath tumors called plexiform neurofibromas (PNs) are a common clinical manifestation of NF1. GOMEKLI (mirdametinib) is the first and only FDA-approved treatment for both adults and children 2 years of age and older with NF1 who have symptomatic PNs not amenable to complete resection. Despite advancements in NF1-PN treatment, unmet needs remain, and patients are in need of more options. GOMEKLI will be marketed to appropriate healthcare professionals in community neurology and oncology centers and NF1 centers of excellence in the U.S., as well as to appropriate patients in the U.S. with NF1-PNs. General marketing efforts will be focused on highlighting the approved indication, efficacy, safety and value that GOMEKLI 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, patients, payers and population health decision makers, on platforms such as social media and other web-based mediums, professional detailing to healthcare providers, payers, and conference events, seminars and speaker programs. Patient support programs will also be offered to facilitate access to GOMEKLI for eligible patients who have been prescribed GOMEKLI, but these programs are not considered marketing or promotional activities.
With respect to its pricing plans for GOMEKLI 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. Major financial and non-financial factors that influenced the decision to set the price of the drug at a level that exceeds the Medicare Part D threshold included: the unique clinical value that GOMEKLI offers as the first and only FDA-approved treatment for both adults and children 2 years of age and older with NF1 who have symptomatic PNs not amenable to complete resection; 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 GOMEKLI; preclinical and ongoing clinical trials for the drug; anticipated discounts and other fees to be negotiated with supply chain partners, including wholesalers, specialty pharmacies, PBMs 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 GOMEKLI outside the U.S. |
None |
4587 |
None |
1 |
2017-08-18 |
229800000.0000 |
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, manufacture and commercialize mirdametinib for the treatment of all diseases. Pursuant to the license agreement, SpringWorks is required to pay Pfizer up to an aggregate of $229.8 million upon achievement of certain commercial milestone events, and will pay Pfizer tiered royalties on sales of mirdametinib 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 |
| SpringWorks Therapeutics |
82448013484 |
Gomekli (mirdametinib) 1mg tablets, 84-ct bottle |
2025-02-18 |
17325.0000 |
Neurofibromatosis type 1 (NF1) is an incurable genetic condition affecting approximately 1 in 2500 newborns worldwide that is caused by a pathogenic variant in the NF1 tumor suppressor gene. Peripheral nerve sheath tumors called plexiform neurofibromas (PNs) are a common clinical manifestation of NF1. GOMEKLI (mirdametinib) is the first and only FDA-approved treatment for both adults and children 2 years of age and older with NF1 who have symptomatic PNs not amenable to complete resection. Despite advancements in NF1-PN treatment, unmet needs remain, and patients are in need of more options. GOMEKLI will be marketed to appropriate healthcare professionals in community neurology and oncology centers and NF1 centers of excellence in the U.S., as well as to appropriate patients in the U.S. with NF1-PNs. General marketing efforts will be focused on highlighting the approved indication, efficacy, safety and value that GOMEKLI 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, patients, payers and population health decision makers, on platforms such as social media and other web-based mediums, professional detailing to healthcare providers, payers, and conference events, seminars and speaker programs. Patient support programs will also be offered to facilitate access to GOMEKLI for eligible patients who have been prescribed GOMEKLI, but these programs are not considered marketing or promotional activities.
With respect to its pricing plans for GOMEKLI 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. Major financial and non-financial factors that influenced the decision to set the price of the drug at a level that exceeds the Medicare Part D threshold included: the unique clinical value that GOMEKLI offers as the first and only FDA-approved treatment for both adults and children 2 years of age and older with NF1 who have symptomatic PNs not amenable to complete resection; 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 GOMEKLI; preclinical and ongoing clinical trials for the drug; anticipated discounts and other fees to be negotiated with supply chain partners, including wholesalers, specialty pharmacies, PBMs 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 GOMEKLI outside the U.S. |
None |
4587 |
None |
1 |
2017-08-18 |
229800000.0000 |
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, manufacture and commercialize mirdametinib for the treatment of all diseases. Pursuant to the license agreement, SpringWorks is required to pay Pfizer up to an aggregate of $229.8 million upon achievement of certain commercial milestone events, and will pay Pfizer tiered royalties on sales of mirdametinib 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 |
| SpringWorks Therapeutics |
82448026042 |
Gomekli (mirdametinib) 2mg Capsules, 42-ct bottle |
2025-02-18 |
17325.0000 |
Neurofibromatosis type 1 (NF1) is an incurable genetic condition affecting approximately 1 in 2500 newborns worldwide that is caused by a pathogenic variant in the NF1 tumor suppressor gene. Peripheral nerve sheath tumors called plexiform neurofibromas (PNs) are a common clinical manifestation of NF1. GOMEKLI (mirdametinib) is the first and only FDA-approved treatment for both adults and children 2 years of age and older with NF1 who have symptomatic PNs not amenable to complete resection. Despite advancements in NF1-PN treatment, unmet needs remain, and patients are in need of more options. GOMEKLI will be marketed to appropriate healthcare professionals in community neurology and oncology centers and NF1 centers of excellence in the U.S., as well as to appropriate patients in the U.S. with NF1-PNs. General marketing efforts will be focused on highlighting the approved indication, efficacy, safety and value that GOMEKLI 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, patients, payers and population health decision makers, on platforms such as social media and other web-based mediums, professional detailing to healthcare providers, payers, and conference events, seminars and speaker programs. Patient support programs will also be offered to facilitate access to GOMEKLI for eligible patients who have been prescribed GOMEKLI, but these programs are not considered marketing or promotional activities.
With respect to its pricing plans for GOMEKLI 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. Major financial and non-financial factors that influenced the decision to set the price of the drug at a level that exceeds the Medicare Part D threshold included: the unique clinical value that GOMEKLI offers as the first and only FDA-approved treatment for both adults and children 2 years of age and older with NF1 who have symptomatic PNs not amenable to complete resection; 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 GOMEKLI; preclinical and ongoing clinical trials for the drug; anticipated discounts and other fees to be negotiated with supply chain partners, including wholesalers, specialty pharmacies, PBMs 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 GOMEKLI outside the U.S. |
None |
4587 |
None |
1 |
2017-08-18 |
229800000.0000 |
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, manufacture and commercialize mirdametinib for the treatment of all diseases. Pursuant to the license agreement, SpringWorks is required to pay Pfizer up to an aggregate of $229.8 million upon achievement of certain commercial milestone events, and will pay Pfizer tiered royalties on sales of mirdametinib 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 |
| SpringWorks Therapeutics |
82448026084 |
Gomekli (mirdametinib) 2mg Capsules, 84-ct bottle |
2025-02-18 |
34650.0000 |
Neurofibromatosis type 1 (NF1) is an incurable genetic condition affecting approximately 1 in 2500 newborns worldwide that is caused by a pathogenic variant in the NF1 tumor suppressor gene. Peripheral nerve sheath tumors called plexiform neurofibromas (PNs) are a common clinical manifestation of NF1. GOMEKLI (mirdametinib) is the first and only FDA-approved treatment for both adults and children 2 years of age and older with NF1 who have symptomatic PNs not amenable to complete resection. Despite advancements in NF1-PN treatment, unmet needs remain, and patients are in need of more options. GOMEKLI will be marketed to appropriate healthcare professionals in community neurology and oncology centers and NF1 centers of excellence in the U.S., as well as to appropriate patients in the U.S. with NF1-PNs. General marketing efforts will be focused on highlighting the approved indication, efficacy, safety and value that GOMEKLI 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, patients, payers and population health decision makers, on platforms such as social media and other web-based mediums, professional detailing to healthcare providers, payers, and conference events, seminars and speaker programs. Patient support programs will also be offered to facilitate access to GOMEKLI for eligible patients who have been prescribed GOMEKLI, but these programs are not considered marketing or promotional activities.
With respect to its pricing plans for GOMEKLI 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. Major financial and non-financial factors that influenced the decision to set the price of the drug at a level that exceeds the Medicare Part D threshold included: the unique clinical value that GOMEKLI offers as the first and only FDA-approved treatment for both adults and children 2 years of age and older with NF1 who have symptomatic PNs not amenable to complete resection; 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 GOMEKLI; preclinical and ongoing clinical trials for the drug; anticipated discounts and other fees to be negotiated with supply chain partners, including wholesalers, specialty pharmacies, PBMs 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 GOMEKLI outside the U.S. |
None |
4587 |
None |
1 |
2017-08-18 |
229800000.0000 |
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, manufacture and commercialize mirdametinib for the treatment of all diseases. Pursuant to the license agreement, SpringWorks is required to pay Pfizer up to an aggregate of $229.8 million upon achievement of certain commercial milestone events, and will pay Pfizer tiered royalties on sales of mirdametinib 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 |
| Stallergenes Greer USA |
22840011407 |
PALFORZIA - Each package contains 13 capsules:
(Level A) One 0.5 mg capsule
(Level B) One 1 mg capsule
(Level C) One 0.5 mg capsule; One 1 mg capsule
(Level D) Three 1 mg capsules
(Level E) Six 1 mg capsules |
2025-03-03 |
959.6400 |
"Marketing to Allergy HCPs that have capability to administer Oral Immunotherapy (OIT). Pricing to be equivalent to other Palforzia doses at time of introduction." |
None |
750 |
None |
None |
None |
None |
None |
None |
None |
None |
| Stallergenes Greer USA |
22840012615 |
PALFORZIA - Each package contains fifteen 1mg capsules |
2025-03-03 |
959.6400 |
"Marketing to Allergy HCPs that have capability to administer Oral Immunotherapy (OIT). Pricing to be equivalent to other Palforzia doses at time of introduction." |
None |
750 |
None |
None |
None |
None |
None |
None |
None |
None |
| SUN PHARMACEUTICALS |
70095004001 |
Deflazacort Oral Tablets 6mg, 100ct |
2025-03-21 |
8185.5800 |
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. Utilizing only publicly available information, Sun determined to set its WAC at the same level as its competitor. It did not utilize the brand WAC in its calculations. |
None |
3100 |
None |
None |
None |
None |
None |
None |
None |
None |
| SUN PHARMACEUTICALS |
70095004130 |
Deflazacort Oral Tablets, 18mg, 30ct |
2025-03-21 |
7367.2100 |
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. Utilizing only publicly available information, Sun determined to set its WAC at the same level as its competitor. It did not utilize the brand WAC in its calculations. |
None |
3100 |
None |
None |
None |
None |
None |
None |
None |
None |
| SUN PHARMACEUTICALS |
70095004230 |
Deflazacort Oral Tablets, 30mg, 30ct |
2025-03-21 |
12279.3100 |
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. Utilizing only publicly available information, Sun determined to set its WAC at the same level as its competitor. It did not utilize the brand WAC in its calculations. |
None |
3100 |
None |
None |
None |
None |
None |
None |
None |
None |
| SUN PHARMACEUTICALS |
70095004330 |
Deflazacort Oral Tablets, 36mg, 30ct |
2025-03-21 |
14214.6900 |
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. Utilizing only publicly available information, Sun determined to set its WAC at the same level as its competitor. It did not utilize the brand WAC in its calculations. |
None |
3100 |
None |
None |
None |
None |
None |
None |
None |
None |
| Syndax Pharmaceuticals, Inc. |
73555050000 |
REVUFORJ (revumenib) 25mg Package Quantity 30 Tablets |
2025-03-19 |
10000.0000 |
None |
1 |
2000 |
1 |
1 |
None |
None |
None |
None |
None |
None |