| Taiho Oncology, Inc. |
64842012004 |
Lytgobi tablets, 12MG (3 tablets); 4MG 21 tablet count DosePak |
Brand |
FDA |
2023-02-10 |
5835.0000 |
None |
1 |
1 |
1 |
1 |
None |
None |
None |
None |
None |
None |
| Taiho Oncology, Inc. |
64842012005 |
Lytgobi tablets, 16MG (4 tablets); 4MG 28 tablet count DosePak |
Brand |
FDA |
2023-02-10 |
5835.0000 |
None |
1 |
1 |
1 |
1 |
None |
None |
None |
None |
None |
None |
| Taiho Oncology, Inc. |
64842012006 |
Lytgobi tablets, 20MG (5 tablets); 4MG 35 tablet count DosePak |
Brand |
FDA |
2023-02-10 |
5835.0000 |
None |
1 |
1 |
1 |
1 |
None |
None |
None |
None |
None |
None |
| Takeda Pharmaceuticals America, Inc. |
63020021021 |
FRUZAQLA™ (fruquintinib) 1mg capsules |
Brand |
FDA |
2023-11-09 |
6300.0000 |
While specific marketing and pricing plans are not available in the public domain, generally we do plan to market FRUZAQLA in the US through print and digital media materials created to be used by sales representatives to share information on FRUZAQLA with prescribers and through the use of print and digital materials made available to educate patients about FRUZAQLA. We will also promote FRUZAQLA to appropriate healthcare professionals, who treat individuals diagnosed with metastatic colorectal cancer (CRC), through engagement at scientific meetings and conferences. Takeda considers a number of factors when deciding the price at which to set its prescription drugs, including, but not limited to: (i) the value medicine brings to patients and society; (ii) access to medicines; and (iii) providing a thoughtful approach that allows us to continue to deliver innovative medicines. CRC is a cancer that starts in either the colon or rectum. According to the International Agency for Research on Cancer, CRC is the third most prevalent cancer worldwide, associated with 935,000 deaths in 2020. In the U.S., it is estimated that 153,000 patients will be diagnosed with CRC and 53,000 deaths from the disease will occur in 2023. Although early-stage CRC can be surgically resected, metastatic CRC remains an area of high unmet need with poor outcomes and limited treatment options. FRUZAQLA is a highly selective and potent inhibitor of vascular endothelial growth factor receptors (VEGFR) -1, -2 and -3 for the treatment of adult patients with previously treated metastatic colorectal cancer (CRC). FRUZAQLA will be the first and only highly selective inhibitor of all three VEGF receptors approved in the U.S. for previously treated metastatic CRC. In establishing WAC, Takeda also evaluated the access landscape for metastatic CRC patients, including the current treatment landscape and associated costs, likelihood of payor coverage, and options for patients without coverage. In addition, Takeda considered its ability to continue to fund the discovery of future oncology innovations and the resources needed to bring new therapies to market. |
None |
743 |
None |
1 |
2023-03-14 |
400000000.0000 |
None |
Upfront payment, additional milestone payments may be due in the future. Total possible payment (upfront and milestones) $730 million. |
The estimated number of patients in any given state in the United States (U.S.) with a condition for which FRUZAQLA may be prescribed each month is not known but it is expected that FRUZAQLA will be able to be prescribed to approximately 7% of all patients diagnosed with CRC in the U.S., or about 10,621 patients. |
None |
| Takeda Pharmaceuticals America, Inc. |
63020022521 |
FRUZAQLA™ (fruquintinib) 5mg capsules |
Brand |
FDA |
2023-11-09 |
25200.0000 |
While specific marketing and pricing plans are not available in the public domain, generally we do plan to market FRUZAQLA in the US through print and digital media materials created to be used by sales representatives to share information on FRUZAQLA with prescribers and through the use of print and digital materials made available to educate patients about FRUZAQLA. We will also promote FRUZAQLA to appropriate healthcare professionals, who treat individuals diagnosed with metastatic colorectal cancer (CRC), through engagement at scientific meetings and conferences. Takeda considers a number of factors when deciding the price at which to set its prescription drugs, including, but not limited to: (i) the value medicine brings to patients and society; (ii) access to medicines; and (iii) providing a thoughtful approach that allows us to continue to deliver innovative medicines. CRC is a cancer that starts in either the colon or rectum. According to the International Agency for Research on Cancer, CRC is the third most prevalent cancer worldwide, associated with 935,000 deaths in 2020. In the U.S., it is estimated that 153,000 patients will be diagnosed with CRC and 53,000 deaths from the disease will occur in 2023. Although early-stage CRC can be surgically resected, metastatic CRC remains an area of high unmet need with poor outcomes and limited treatment options. FRUZAQLA is a highly selective and potent inhibitor of vascular endothelial growth factor receptors (VEGFR) -1, -2 and -3 for the treatment of adult patients with previously treated metastatic colorectal cancer (CRC). FRUZAQLA will be the first and only highly selective inhibitor of all three VEGF receptors approved in the U.S. for previously treated metastatic CRC. In establishing WAC, Takeda also evaluated the access landscape for metastatic CRC patients, including the current treatment landscape and associated costs, likelihood of payor coverage, and options for patients without coverage. In addition, Takeda considered its ability to continue to fund the discovery of future oncology innovations and the resources needed to bring new therapies to market. |
None |
9878 |
None |
1 |
2023-03-14 |
400000000.0000 |
None |
Upfront payment, additional milestone payments may be due in the future. Total possible payment (upfront and milestones) $730 million. |
The estimated number of patients in any given state in the United States (U.S.) with a condition for which FRUZAQLA may be prescribed each month is not known but it is expected that FRUZAQLA will be able to be prescribed to approximately 7% of all patients diagnosed with CRC in the U.S., or about 10,621 patients. |
None |
| Takeda Pharmaceuticals America, Inc. |
64764014505 |
ADZYNMA Intravenous Solution Reconstituted 1500 Unit |
Brand |
FDA |
2023-11-29 |
3.2800 |
Takeda’s marketing plans, including the spending associated with Takeda’s marketing tactics, are confidential and proprietary, and not available in the public domain. However, marketing to support product launch will include print and digital media materials, including emails, a website for healthcare professionals, detailing materials for sales representatives to share information about Adzynma with appropriate prescribers, including for patient education, and attendance at professional congresses. Takeda used a value-based pricing methodology in setting the launch price of ADZYNMA, and considered several factors including, but not limited to: (i) the value the medicine brings to patients and society; (ii) the ability of patients to access our medicines; and (iii) our mission of continuing to develop, research, and market new medicines to address patients’ unmet needs. For more information, please see Takeda's Pricing Philosophy. |
None |
1 |
1 |
1 |
None |
None |
None |
None |
For the estimated number of patients, we included '1' simply because we are required to enter a number into this field. We offer the following additional explanation. ADZYNMA (ADAMTS13, recombinant-krhn), an orphan drug, is indicated for prophylactic or on-demand enzyme replacement therapy in adult and pediatric patients with congenital thrombotic thrombocytopenic purpura (cTTP). cTTP is an ultra-rare, chronic and debilitating blood clotting disorder. Due to the nature of the disease for which ADZYNMA is indicated, Takeda has not determined a specific volume of patients for whom ADZYNMA may be prescribed, and therefore an estimated volume of patients in the US for whom ADZYNMA may be prescribed is not available in the public domain. The International Society on Thrombosis and Haemostasis (ISTH) diagnostic guidelines cite the annual incidence of thrombotic thrombocytopenic purpura (TTP) as two to six cases per million per year globally. Because the inherited form of the disease, cTTP, is ultra-rare, its incidence is uncertain, but studies suggest that it accounts for between 3-5% of patients with TTP.
ADZYNMA (rADAMTS13) is supplied in a single-dose vial and contains nominally 500 IU or 1500 IU of rADAMTS13. Each vial is labeled with the specific number of units of ADAMTS13 potency expressed in IU, and the price of a vial is the price per IU multiplied by the specific number of units in that vial. The WAC price at introduction is $3.28 per IU but has been reported at a nominal package level. |
None |
| Takeda Pharmaceuticals America, Inc. |
64764014005 |
ADZYNMA Intravenous Solution Reconstituted 500 Unit |
Brand |
FDA |
2023-11-29 |
3.2800 |
Takeda’s marketing plans, including the spending associated with Takeda’s marketing tactics, are confidential and proprietary, and not available in the public domain. However, marketing to support product launch will include print and digital media materials, including emails, a website for healthcare professionals, detailing materials for sales representatives to share information about Adzynma with appropriate prescribers, including for patient education, and attendance at professional congresses. Takeda used a value-based pricing methodology in setting the launch price of ADZYNMA, and considered several factors including, but not limited to: (i) the value the medicine brings to patients and society; (ii) the ability of patients to access our medicines; and (iii) our mission of continuing to develop, research, and market new medicines to address patients’ unmet needs. For more information, please see Takeda's Pricing Philosophy. |
None |
1 |
1 |
1 |
None |
None |
None |
None |
For the estimated number of patients, we included '1' simply because we are required to enter a number into this field. We offer the following additional explanation. ADZYNMA (ADAMTS13, recombinant-krhn), an orphan drug, is indicated for prophylactic or on-demand enzyme replacement therapy in adult and pediatric patients with congenital thrombotic thrombocytopenic purpura (cTTP). cTTP is an ultra-rare, chronic and debilitating blood clotting disorder. Due to the nature of the disease for which ADZYNMA is indicated, Takeda has not determined a specific volume of patients for whom ADZYNMA may be prescribed, and therefore an estimated volume of patients in the US for whom ADZYNMA may be prescribed is not available in the public domain. The International Society on Thrombosis and Haemostasis (ISTH) diagnostic guidelines cite the annual incidence of thrombotic thrombocytopenic purpura (TTP) as two to six cases per million per year globally. Because the inherited form of the disease, cTTP, is ultra-rare, its incidence is uncertain, but studies suggest that it accounts for between 3-5% of patients with TTP.
ADZYNMA (rADAMTS13) is supplied in a single-dose vial and contains nominally 500 IU or 1500 IU of rADAMTS13. Each vial is labeled with the specific number of units of ADAMTS13 potency expressed in IU, and the price of a vial is the price per IU multiplied by the specific number of units in that vial. The WAC price at introduction is $3.28 per IU but has been reported at a nominal package level. |
None |
| Tarsus Pharmaceuticals, Inc. |
81942012501 |
XDEMVY™, Lotilaner Ophthalmic Solution 0.25%, 10 mL bottle |
Brand |
FDA |
2023-08-24 |
1850.0000 |
None |
1 |
7000000 |
None |
None |
None |
None |
None |
None |
None |
None |
| Teva Neuroscience, Inc. |
68546047156 |
AUSTEDO XR® 12mg (30ct) |
Brand |
FDA |
2023-05-08 |
4720.5000 |
None |
1 |
533000 |
None |
None |
None |
None |
None |
None |
Research suggests that the diagnosed prevelance for Huntington's is about 33,000. Tardive dyskinesia affects about 500,000 individuals in the United States; Teva developed this product. |
None |
| Teva Neuroscience, Inc. |
68546047256 |
AUSTEDO XR® 24mg (30ct) |
Brand |
FDA |
2023-05-08 |
7080.7000 |
None |
1 |
533000 |
None |
None |
None |
None |
None |
None |
Research suggests that the diagnosed prevelance for Huntington's is about 33,000. Tardive dyskinesia affects about 500,000 individuals in the United States; Teva developed this product. |
None |
| Teva Neuroscience, Inc. |
68546047056 |
AUSTEDO XR® 6mg (30ct) |
Brand |
FDA |
2023-05-08 |
2360.2500 |
None |
1 |
533000 |
None |
None |
None |
None |
None |
None |
Research suggests that the diagnosed prevelance for Huntington's is about 33,000. Tardive dyskinesia affects about 500,000 individuals in the United States; Teva developed this product. |
None |
| Teva Neuroscience, Inc. |
51759052010 |
UZEDY ER Inj. 100mg/0.28 ML |
Brand |
FDA |
2023-05-17 |
2464.0000 |
None |
1 |
3300000 |
None |
None |
None |
None |
None |
None |
Research suggests there are 3,300,000 schizophrenia patients in the US. Acquisition fields left blank; Teva developed this product. |
None |
| Teva Neuroscience, Inc. |
51759063010 |
UZEDY ER Inj. 125mg/0.35 ML |
Brand |
FDA |
2023-05-17 |
3080.0000 |
None |
1 |
3300000 |
None |
None |
None |
None |
None |
None |
Research suggests there are 3,300,000 schizophrenia patients in the US. Acquisition fields left blank; Teva developed this product. |
None |
| Teva Neuroscience, Inc. |
51759074010 |
UZEDY ER Inj. 150mg/0.42 ML |
Brand |
FDA |
2023-05-17 |
3696.0000 |
None |
1 |
3300000 |
None |
None |
None |
None |
None |
None |
Research suggests there are 3,300,000 schizophrenia patients in the US. Acquisition fields left blank; Teva developed this product. |
None |
| Teva Neuroscience, Inc. |
51759085010 |
UZEDY ER Inj. 200mg/0.56 ML |
Brand |
FDA |
2023-05-17 |
4928.0000 |
None |
1 |
3300000 |
None |
None |
None |
None |
None |
None |
Research suggests there are 3,300,000 schizophrenia patients in the US. Acquisition fields left blank; Teva developed this product. |
None |
| Teva Neuroscience, Inc. |
51759096010 |
UZEDY ER Inj. 250mg/0.70 ML |
Brand |
FDA |
2023-05-17 |
6160.0000 |
None |
1 |
3300000 |
None |
None |
None |
None |
None |
None |
Research suggests there are 3,300,000 schizophrenia patients in the US. Acquisition fields left blank; Teva developed this product. |
None |
| Teva Neuroscience, Inc. |
51759030510 |
UZEDY ER Inj. 50mg/0.14 ML |
Brand |
FDA |
2023-05-17 |
1232.0000 |
None |
1 |
3300000 |
None |
None |
None |
None |
None |
None |
Research suggests there are 3,300,000 schizophrenia patients in the US. Acquisition fields left blank; Teva developed this product. |
None |
| Teva Neuroscience, Inc. |
51759041010 |
UZEDY ER Inj. 75mg/0.21 ML |
Brand |
FDA |
2023-05-17 |
1848.0000 |
None |
1 |
3300000 |
None |
None |
None |
None |
None |
None |
Research suggests there are 3,300,000 schizophrenia patients in the US. Acquisition fields left blank; Teva developed this product. |
None |
| Teva Neuroscience, Inc. |
68546049052 |
AUSTEDO® XR Patient Titration Kit |
Brand |
FDA |
2023-08-01 |
6608.6800 |
None |
1 |
533000 |
None |
None |
None |
None |
None |
None |
Research suggests that the diagnosed prevelance for Huntington's is about 33,000. Tardive dyskinesia affects about 500,000 individuals in the United States; Teva developed this product. |
None |
| Teva Pharmaceuticals USA |
00480542589 |
SORAFENIB TOSYLATE TABLET 200MG 120 |
Generic |
FDA |
2023-01-03 |
10874.4700 |
None |
1 |
50000 |
None |
None |
None |
None |
None |
None |
Research suggests that there are roughly 50,000 patients in the US whose conditions match the product’s approved indications and, thus, are candidates to take the product. Acquisition fields left blank; Teva developed the product. |
None |
| Teva Pharmaceuticals USA |
00480124128 |
LENALIDOMIDE CAPSULE 2.5MG 28 |
Generic |
FDA |
2023-03-08 |
20157.3600 |
None |
1 |
70000 |
None |
None |
None |
None |
None |
None |
Research suggests that there are as many as 70,000 patients in the US whose conditions match the product’s approved indications and, thus, are candidates to take the product. Acquisition fields left blank; Teva developed this product, in partnership with Natco Pharma. |
None |
| Teva Pharmaceuticals USA |
00480124521 |
LENALIDOMIDE CAPSULE 20MG 21 |
Generic |
FDA |
2023-03-08 |
15118.0400 |
None |
1 |
70000 |
None |
None |
None |
None |
None |
None |
Research suggests that there are as many as 70,000 patients in the US whose conditions match the product’s approved indications and, thus, are candidates to take the product. Acquisition fields left blank; Teva developed this product, in partnership with Natco Pharma. |
None |
| Teva Pharmaceuticals USA |
00480235901 |
TOPIRAMATE ER CAPSULE 200MG 100 |
Generic |
FDA |
2023-03-31 |
3750.7500 |
None |
1 |
21300000 |
None |
1 |
None |
None |
None |
None |
Research suggests that as many as 21.3 million Americans, in total, suffer from the conditions that this product is indicated to treat. Acquisition fields left blank; Teva developed the product. |
None |
| Teva Pharmaceuticals USA |
00480235956 |
TOPIRAMATE ER CAPSULE 200MG 30 |
Generic |
FDA |
2023-03-31 |
1125.2400 |
None |
1 |
21300000 |
None |
1 |
None |
None |
None |
None |
Research suggests that as many as 21.3 million Americans, in total, suffer from the conditions that this product is indicated to treat. Acquisition fields left blank; Teva developed the product. |
None |
| Teva Pharmaceuticals USA |
00480235801 |
TOPIRAMATE ER CAPSULE 100MG 100 |
Generic |
FDA |
2023-05-03 |
2741.9200 |
None |
1 |
21300000 |
None |
1 |
None |
None |
None |
None |
Research suggests that as many as 21.3 million Americans, in total, suffer from the conditions that this product is indicated to treat. Acquisition fields left blank; Teva developed the product. |
None |
| Teva Pharmaceuticals USA |
00480235601 |
TOPIRAMATE ER CAPSULE 25MG 100 |
Generic |
FDA |
2023-05-03 |
1062.4100 |
None |
1 |
21300000 |
None |
1 |
None |
None |
None |
None |
Research suggests that as many as 21.3 million Americans, in total, suffer from the conditions that this product is indicated to treat. Acquisition fields left blank; Teva developed the product. |
None |
| Teva Pharmaceuticals USA |
00480235701 |
TOPIRAMATE ER CAPSULE 50MG 100 |
Generic |
FDA |
2023-05-03 |
1383.9000 |
None |
1 |
21300000 |
None |
1 |
None |
None |
None |
None |
Research suggests that as many as 21.3 million Americans, in total, suffer from the conditions that this product is indicated to treat. Acquisition fields left blank; Teva developed the product. |
None |
| Teva Pharmaceuticals USA |
00480405356 |
GEFITINIB TABLET 250MG 30 |
Generic |
FDA |
2023-06-21 |
4439.6600 |
None |
1 |
80000 |
None |
None |
None |
None |
None |
None |
Research suggests that as many as 80,000 Americans, in total, suffer from the condition that this product is indicated to treat. Acquisition fields left blank; Teva developed the product. |
None |
| Teva Pharmaceuticals USA |
00480432001 |
PLERIXAFOR INJ 24MG/1.2ML (20MG/ML) 1 |
Generic |
FDA |
2023-07-28 |
1200.0000 |
None |
1 |
285000 |
None |
None |
None |
None |
None |
None |
Research suggests that as many as 285,000 Americans, in total, suffer from the condition that this product is indicated to treat. Acquisition fields left blank; Teva developed the product. |
None |
| Teva Pharmaceuticals USA |
00480368501 |
AMPHETAMINE MIX SALT ER CAPS 37.5MG 100 |
Generic |
FDA |
2023-10-10 |
975.8100 |
None |
1 |
4500000 |
None |
1 |
None |
None |
None |
None |
Research suggests that as many as $4.5 million Americans, in total, suffer from the condition that this product is indicated to treat. Acquisition fields left blank; Teva developed the product. |
None |
| Teva Pharmaceuticals USA |
00480368301 |
AMPHETAMINE MIX SALTS ER CAPS 12.5MG 100 |
Generic |
FDA |
2023-10-10 |
975.8100 |
None |
1 |
4500000 |
None |
1 |
None |
None |
None |
None |
Research suggests that as many as $4.5 million Americans, in total, suffer from the condition that this product is indicated to treat. Acquisition fields left blank; Teva developed the product. |
None |
| Teva Pharmaceuticals USA |
00480368401 |
AMPHETAMINE MIX SALTS ER CAPS 25MG 100 |
Generic |
FDA |
2023-10-10 |
975.8100 |
None |
1 |
4500000 |
None |
1 |
None |
None |
None |
None |
Research suggests that as many as $4.5 million Americans, in total, suffer from the condition that this product is indicated to treat. Acquisition fields left blank; Teva developed the product. |
None |
| Teva Pharmaceuticals USA |
00480368601 |
AMPHETAMINE MIX SALTS ER CAPS 50MG 100 |
Generic |
FDA |
2023-10-10 |
975.8100 |
None |
1 |
4500000 |
None |
1 |
None |
None |
None |
None |
Research suggests that as many as $4.5 million Americans, in total, suffer from the condition that this product is indicated to treat. Acquisition fields left blank; Teva developed the product. |
None |
| Teva Pharmaceuticals USA |
00480418489 |
PAZOPANIB HCL TABLET 200MG 120 |
Generic |
FDA |
2023-10-20 |
11294.2300 |
None |
1 |
580000 |
None |
None |
None |
None |
None |
None |
Research suggests that as many as 580,000 Americans, in total, suffer from the conditions that this product is indicated to treat. Acquisition fields left blank; Teva developed the product. |
None |
| Teva Pharmaceuticals USA |
00093776924 |
EVEROLIMUS TABLETS 10MG 28 (7X4) |
Generic |
FDA |
2023-10-23 |
933.3300 |
None |
1 |
930000 |
None |
None |
None |
None |
None |
None |
Research suggests that as many as 930,000 Americans, in total, suffer from the conditions that this product is indicated to treat. Acquisition fields left blank; Teva developed the product. |
None |
| Teva Pharmaceuticals USA |
00591474030 |
DEFERASIROX GRANULE 360MG 30 |
Generic |
FDA |
2023-11-10 |
1333.1800 |
None |
1 |
5000000 |
None |
None |
None |
None |
None |
None |
Research suggests that as many as 5 million patients receive blood transfusions annually in the US and, thus, may be eligible to take this product. Acquisition fields left blank; Teva developed the product. |
None |
| Teva Pharmaceuticals USA |
00480145308 |
RISPERIDONE SR INJ 50MG 2ML KIT |
Generic |
FDA |
2023-12-11 |
1062.0400 |
None |
1 |
7000000 |
None |
None |
None |
None |
None |
None |
Research suggests that as many as 7 million Americans, in total, suffer from the conditions that this product is indicated to treat. Acquisition fields left blank; Teva developed the product. |
None |
| Teva Pharmaceuticals USA |
00093110616 |
TERIPARATIDE INJ PEN 0.25MG/ML 2.4ML 1 |
Generic |
FDA |
2023-12-18 |
2896.3000 |
None |
1 |
283000000 |
None |
1 |
None |
None |
None |
None |
Research suggests that as many as 283 million Americans, in total, suffer from the conditions that this product is indicated to treat. Acquisition fields left blank; Teva developed the product. |
None |
| TG Therapeutics, Inc. |
73150015006 |
BRIUMVI (ublituximab-xiiy) 150 mg/6 mL Vial |
Brand |
FDA |
2023-01-26 |
9833.3300 |
Marketing Plan:
BRIUMVI was approved on 12/28/22 as a CD20-directed cytolytic antibody indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. TG Therapeutics has designed marketing activities to raise awareness and understanding with Healthcare Providers, Patients and Care Partners about the approved indications, efficacy, safety and patient support services offerings available.
TG Therapeutics will take a very targeted approach to paid advertising to both Healthcare Providers, Patients and Care Partners. TG is not planning on executing DTC advertising via TV executions at this time, instead there will be a focus on leveraging digital platforms such as banner, social media, paid search, etc. We will, however, have a patient-facing website that provides information about BRIUMVI, the diseases it is approved to treat, and the BRIUMVI Patient Support Program.
At launch TG will not offer coupons or free trials or other promotional incentives. However, at launch TG will offer copayment assistance to commercially insured patients through the BRIUMVI Patient Support Program. Information about the BRIUMVI Patient Support Program, including the commercial co-pay program, will be provided to healthcare providers (“HCPs”) by our sales representatives and via an HCP website, and to patients via a patient-facing website.
In preparation for launch over the 2022 calendar year, promotional spend was focused on creating content for HCPs to raise awareness of TG Therapeutics, including medical congress activities and unbranded speaker programs. From a branded perspective promotional spend was focused on developing content in anticipation for the launch of BRIUMVI, including non-personal promotion (branded website and in office resources).
Pricing Plans:
TG Therapeutics was founded with one broad mission: to develop novel and valuable treatment options for patients with B-cell diseases. Our commitment to patients, however, goes beyond science. We believe that access is essential in ensuring advances are available to patients who are in need of treatment options. This is why we created a unique approach to our decision-making around access and pricing anchored on the clinical value of our products and guided by three core pillars: fiercely focused on patients, access and solutions. TG Therapeutics is committed to responsible pricing and partnership across the healthcare system and we listened carefully to the MS community, including neurologists, patients, payers and advocacy groups to ensure that we priced BRIUMVI to optimize access for patients. |
None |
70000 |
None |
None |
2012-01-30 |
None |
1 |
TG Therapeutics does not believe the acquisition price is in the public domain or publicly available. Accordingly, TG Therapeutics is limiting its response to this item pursuant to California Health & Safety Code § 127681(c). |
Comment regarding number of Estimated Patients field: There are currently 900,000 – 1,000,000 patients diagnosed with MS in the US, with ~350,000 receiving an MS DMT in any given year. Each year there are approximately 80,000 – 90,000 patients in the US who are in need of a new MS treatment. Approximately ~85% of MS patients fall within our FDA labelled indications (Relapsing MS). |
None |
| Tolmar Inc |
62935046150 |
ELIGARD® 45mg (leuprolide acetate for injectable suspension) 6 months of therapy |
Brand |
FDA |
2023-03-08 |
2710.1300 |
Marketing activities that support the launch of a new medicine are designed to raise awareness and understanding with healthcare providers, patients, and caregivers about the approved indication, efficacy and safety data contained within the medicine's FDA approved label. Generally, Tolmar markets in the US at medical conferences in the urology and oncology community, as well as promoting to appropriate healthcare professionals, patients, and caregivers |
None |
45000 |
None |
None |
None |
None |
None |
None |
As part of Tolmar’s commitment to advancing science and patient care, Tolmar has launched a new Eligard®(leuprolide acetate) for injectable suspension. The new Eligard is designed to streamline the mixing and administration process by providing the product in a single, pre-connected unit |
None |
| Tolmar Inc |
62935016360 |
FENSOLVI® 45mg (leuprolide acetate for injectable suspension) 6 months of therapy |
Brand |
FDA |
2023-04-01 |
24891.6800 |
Marketing activities that support the launch of a new medicine are designed to raise awareness and understanding with healthcare providers, patients, and caregivers about the approved indication, efficacy and safety data contained within the medicine's FDA approved label. Generally, Tolmar markets in the US at medical conferences in the pediatric Endocrinology community, as well as promoting to appropriate healthcare professionals, patients, and caregivers |
None |
1200 |
None |
None |
None |
None |
None |
None |
As part of Tolmar’s commitment to advancing science and patient care, Tolmar has launched a new Fensolvi®(leuprolide acetate) for injectable suspension. The new Fensolvi® is designed to streamline the mixing and administration process by providing the product in a single, pre-connected unit |
None |
| Tolmar Inc |
62935022710 |
ELIGARD® 22.5 MG (leuprolide acetate for injectable suspension) 3 months of therapy |
Brand |
FDA |
2023-12-01 |
1355.0700 |
Marketing activities that support the launch of a new medicine are designed to raise awareness and understanding with healthcare providers, patients, and caregivers about the approved indication, efficacy and safety data contained within the medicine's FDA approved label. Generally, Tolmar markets in the US at medical conferences in the urology and oncology community, as well as promoting to appropriate healthcare professionals, patients, and caregivers |
None |
45000 |
None |
None |
None |
None |
None |
None |
As part of Tolmar’s commitment to advancing science and patient care, Tolmar has launched a new Eligard®(leuprolide acetate) for injectable suspension. The new Eligard is designed to streamline the mixing and administration process by providing the product in a single, pre-connected unit |
None |
| Travere Therapeutics, Inc. |
68974020030 |
Filspari (sparsentan) Oral tablets, 200mg, 30 tablets |
Brand |
FDA |
2023-02-28 |
9900.0000 |
Our marketing and market access teams, supported by third-party agencies with rare disease experience, drives our commercialization and disease awareness efforts in the United States. Specifically, we implement a variety of industry accepted programs to educate physicians, including direct-to-physician contact by sales representatives, peer-to-peer educational programs, and participation in targeted medical convention programs.
We plan to distribute FILSPARI through three direct to patient pharmacies, and operate Travere TotalCare, pursuant to which we will provide our comprehensive patient support services. This patient support program for FILSPARI in the United States will provide services, assistance and resources that will help patients understand IgAN, manage the insurance process, fill their prescriptions and initiate treatment. Travere has a long-standing commitment to setting prices responsibly based on the value our medicines bring to patients, society and healthcare systems. Our approach reflects our commitment to continued transparency in how we price our prescription medicines in the United States while minimizing our contribution to health system spending.
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 the following factors
1) Clinical value and outcomes, or the benefit the medicine delivers to patients, and how well it works compared to a standard of care;
2) Economic value, or how the medicine reduces the need—and therefore costs—of other healthcare interventions
3) Social value, or how the medicine contributes to quality of life, and productivity. |
None |
1500 |
None |
1 |
None |
None |
None |
None |
None |
None |
| Travere Therapeutics, Inc. |
68974040030 |
Filspari (sparsentan) Oral tablets, 400mg, 30 tablets |
Brand |
FDA |
2023-03-01 |
9900.0000 |
Our marketing and market access teams, supported by third-party agencies with rare disease experience, drives our commercialization and disease awareness efforts in the United States. Specifically, we implement a variety of industry accepted programs to educate physicians, including direct-to-physician contact by sales representatives, peer-to-peer educational programs, and participation in targeted medical convention programs.
We plan to distribute FILSPARI through three direct to patient pharmacies, and operate Travere TotalCare, pursuant to which we will provide our comprehensive patient support services. This patient support program for FILSPARI in the United States will provide services, assistance and resources that will help patients understand IgAN, manage the insurance process, fill their prescriptions and initiate treatment. Travere has a long-standing commitment to setting prices responsibly based on the value our medicines bring to patients, society and healthcare systems. Our approach reflects our commitment to continued transparency in how we price our prescription medicines in the United States while minimizing our contribution to health system spending.
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 the following factors
1) Clinical value and outcomes, or the benefit the medicine delivers to patients, and how well it works compared to a standard of care;
2) Economic value, or how the medicine reduces the need—and therefore costs—of other healthcare interventions
3) Social value, or how the medicine contributes to quality of life, and productivity. |
None |
1500 |
None |
1 |
None |
None |
None |
None |
None |
None |
| TruPharma, LLC |
52817061516 |
Tramadol 5mg/mL Solution, Oral 473mL |
Generic |
FDA |
2023-01-27 |
471.0500 |
This drug is a generic product; therefore no marketing and pricing plans are available. This product is sold in the United States only. |
None |
48790 |
None |
None |
None |
None |
None |
None |
None |
None |
| TruPharma, LLC |
52817062008 |
Baclofen Solution, Oral 10mg/5mL 273mL |
Generic |
FDA |
2023-11-10 |
661.5000 |
This drug is a generic product; therefore no marketing and pricing plans are available. This product is sold in the United States only. |
None |
7596 |
None |
None |
None |
None |
None |
None |
None |
None |