| Takeda Pharmaceuticals America, Inc. |
63020004012 |
EXKIVITY™ (mobocertinib) capsules |
2021-09-20 |
25000.0000 |
While specific marketing and pricing plans are not available in the public domain, generally we do plan to market Exkivity in the US through print and digital media materials created to be used by sales representatives to share information on Exkivity with prescribers and through the use of print and digital materials made available to educate patients about Exkivity. We will also promote Exkivity to appropriate healthcare professionals, who treat individuals diagnosed with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) Exon 20 insertion, a rare condition, 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. Patients with epidermal growth factor receptor (EGFR) Exon20 insertion+ non-small cell lung cancer (NSCLC) make up approximately 1-2% of patients with NSCLC. This disease carries a worse prognosis than other EGFR mutations and has been historically underserved. Exkivity is a first-in-class, oral tyrosine kinase inhibitor (TKI) specifically designed to selectively target epidermal growth factor receptor (EGFR) Exon20 insertion mutations. In establishing WAC, Takeda also evaluated the access landscape for EGFR Exon20 insertion+ NSCLC 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 |
4000 |
1 |
1 |
None |
None |
None |
None |
The estimated number of patients in any given state in the United States (U.S.) with a condition for which EXKIVITY may be prescribed each month is not known but EGFR exon 20 disease makes up 1% to 2% of all NSCLC cases, or about 2,000 to 4,000 patients per year in the U.S. |
None |
| TARO PHARMACEUTICALS |
51672417406 |
Imiquimod Cream |
2021-02-09 |
1040.9300 |
This product (ANDA approval) is being marketed in the generic, multisource space. This product is priced to reflect a discount off of the Reference Drug listed by the FDA. |
None |
2408 |
None |
None |
None |
None |
None |
None |
None |
None |
| Teva Pharmaceuticals USA |
51759020222 |
AJOVY® (fremanezumab-vfrm) Injection Autoinjector Triple Pack |
2021-01-19 |
1900.0800 |
None |
1 |
19000000 |
None |
None |
None |
None |
None |
None |
Estimated average of approximately 80,000 prescriptions per year, based on historic sales data, although research suggests that as many as 19 million Americans suffer from migraines, which this product is indicated to prevent.
Acquisition fields left blank; Teva developed this product. |
None |
| Teva Pharmaceuticals USA |
00591243315 |
ISOTRETINOIN CAPSULE 10MG 30 |
2021-04-30 |
763.5700 |
None |
1 |
7000000 |
None |
1 |
None |
None |
None |
None |
Estimated average of approximately 96,000 prescriptions per year (across all dosage strengths), based on historic IQVIA data, although research suggests that approximately 7,000,000 patients, age 12 and older, suffer from severe recalcitrant nodular acne, and thus are candidates to take this product. Acquisition fields left blank; Teva developed this product. |
None |
| Teva Pharmaceuticals USA |
00591243415 |
ISOTRETINOIN CAPSULE 20MG 30 |
2021-04-30 |
763.5700 |
None |
1 |
7000000 |
None |
1 |
None |
None |
None |
None |
Estimated average of approximately 96,000 prescriptions per year (across all dosage strengths), based on historic IQVIA data, although research suggests that approximately 7,000,000 patients, age 12 and older, suffer from severe recalcitrant nodular acne, and thus are candidates to take this product. Acquisition fields left blank; Teva developed this product. |
None |
| Teva Pharmaceuticals USA |
00591245115 |
ISOTRETINOIN CAPSULE 25MG 30 |
2021-04-30 |
821.5600 |
None |
1 |
7000000 |
None |
1 |
None |
None |
None |
None |
Estimated average of approximately 96,000 prescriptions per year (across all dosage strengths), based on historic IQVIA data, although research suggests that approximately 7,000,000 patients, age 12 and older, suffer from severe recalcitrant nodular acne, and thus are candidates to take this product. Acquisition fields left blank; Teva developed this product. |
None |
| Teva Pharmaceuticals USA |
00591243515 |
ISOTRETINOIN CAPSULE 30MG 30 |
2021-04-30 |
821.5600 |
None |
1 |
7000000 |
None |
1 |
None |
None |
None |
None |
Estimated average of approximately 96,000 prescriptions per year (across all dosage strengths), based on historic IQVIA data, although research suggests that approximately 7,000,000 patients, age 12 and older, suffer from severe recalcitrant nodular acne, and thus are candidates to take this product. Acquisition fields left blank; Teva developed this product. |
None |
| Teva Pharmaceuticals USA |
00591250115 |
ISOTRETINOIN CAPSULE 35MG 30 |
2021-04-30 |
821.5600 |
None |
1 |
7000000 |
None |
1 |
None |
None |
None |
None |
Estimated average of approximately 96,000 prescriptions per year (across all dosage strengths), based on historic IQVIA data, although research suggests that approximately 7,000,000 patients, age 12 and older, suffer from severe recalcitrant nodular acne, and thus are candidates to take this product. Acquisition fields left blank; Teva developed this product. |
None |
| Teva Pharmaceuticals USA |
00591243615 |
ISOTRETINOIN CAPSULE 40MG 30 |
2021-04-30 |
821.5600 |
None |
1 |
7000000 |
None |
1 |
None |
None |
None |
None |
Estimated average of approximately 96,000 prescriptions per year (across all dosage strengths), based on historic IQVIA data, although research suggests that approximately 7,000,000 patients, age 12 and older, suffer from severe recalcitrant nodular acne, and thus are candidates to take this product. Acquisition fields left blank; Teva developed this product. |
None |
| Teva Pharmaceuticals USA |
00093557201 |
ERYTHROMYCIN TABLETS 500MG 100 |
2021-05-04 |
997.1000 |
None |
1 |
66000000 |
None |
1 |
None |
None |
None |
None |
Estimated average of approximately 140,000 prescriptions per year, based on historic IQVIA data, although research suggests that approximately 66,000,000 patients per year are prescribed outpatient pharmacy antibiotics, and thus are candidates to take this product. Acquisition fields left blank; Teva developed this product. |
None |
| Teva Pharmaceuticals USA |
00093790901 |
TIOPRONIN ORAL TABLETS 100MG 100CT |
2021-05-17 |
2437.2700 |
None |
1 |
13200 |
None |
1 |
None |
None |
None |
None |
Research suggests that approximately 13,200 patients in the US suffer from severe homozygous cystinuria, and thus are candidates to take this product. Acquisition fields left blank; Teva developed this product. |
None |
| Teva Pharmaceuticals USA |
00093406106 |
FORMOTEROL FUMARATE INH SOL 10MCG/ML 60 |
2021-06-22 |
963.7900 |
None |
1 |
26500000 |
None |
None |
None |
None |
None |
None |
Estimated average of approximately 195,300 prescriptions per year, based on historic IQVIA data, although research suggests that approximately 26,500,000 US adults suffer from chronic obstructive pulmonary disease, and thus are candidates to take this product. Acquisition fields left blank; Teva developed this product. |
None |
| Teva Pharmaceuticals USA |
00591283201 |
BEXAROTENE 75MG SGL CAPSULES 100 |
2021-11-11 |
2835.7000 |
None |
1 |
1100 |
None |
None |
None |
None |
None |
None |
Estimated average of 700 prescriptions per month, based on historic IQVIA data. Research similarly suggests that there are approximately 1,100 patients in the US who suffer from cutaneous T-cell lymphoma and are being treated with bexarotene.
Acquisition fields left blank; Teva developed this product. |
None |
| Teva Pharmaceuticals USA |
00093766256 |
ERLOTINIB HCL TABLETS EQ 25MG 30 |
2021-12-08 |
1673.6800 |
None |
1 |
32000 |
None |
None |
None |
None |
None |
None |
Estimated average of up to 119 prescriptions per month, based on historic IQVIA data, although research suggests that there are as many as 32,000 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. |
None |
| Teva Pharmaceuticals USA |
00480372001 |
PYRIMETHAMINE TABLETS 25MG 100 |
2021-12-15 |
25650.0000 |
None |
1 |
2000 |
None |
1 |
None |
None |
None |
None |
Estimated average of roughly 100 prescriptions per month, based on historic IQVIA data, although research suggests that as many as 2,000 Americans take the product annually. Acquisition fields left blank; Teva developed this product. |
None |
| Teva Pharmaceuticals USA |
00480372056 |
PYRIMETHAMINE TABLETS 25MG 30 |
2021-12-15 |
7695.0000 |
None |
1 |
2000 |
None |
1 |
None |
None |
None |
None |
Estimated average of roughly 100 prescriptions per month, based on historic IQVIA data, although research suggests that as many as 2,000 Americans take the product annually. Acquisition fields left blank; Teva developed this product. |
None |
| Teva Pharmaceuticals USA |
00093819928 |
SUNITINIB MALATE CAPSULES 12.5MG 28 |
2021-12-22 |
4889.0700 |
None |
1 |
2800 |
None |
1 |
None |
None |
None |
None |
Estimated average of up to 1,057 prescriptions per month (across all dosage strengths), based on historic IQVIA data, although research suggests that as many as 2,800 Americans take the product annually. Acquisition fields left blank; Teva developed this product. |
None |
| Teva Pharmaceuticals USA |
00093822428 |
SUNITINIB MALATE CAPSULES 25MG 28 |
2021-12-22 |
9778.1600 |
None |
1 |
2800 |
None |
1 |
None |
None |
None |
None |
Estimated average of up to 1,057 prescriptions per month (across all dosage strengths), based on historic IQVIA data, although research suggests that as many as 2,800 Americans take the product annually. Acquisition fields left blank; Teva developed this product. |
None |
| Teva Pharmaceuticals USA |
00093822928 |
SUNITINIB MALATE CAPSULES 37.5MG 28 |
2021-12-22 |
14667.2500 |
None |
1 |
2800 |
None |
1 |
None |
None |
None |
None |
Estimated average of up to 1,057 prescriptions per month (across all dosage strengths), based on historic IQVIA data, although research suggests that as many as 2,800 Americans take the product annually. Acquisition fields left blank; Teva developed this product. |
None |
| Teva Pharmaceuticals USA |
00093823128 |
SUNITINIB MALATE CAPSULES 50MG 28 |
2021-12-22 |
17022.4000 |
None |
1 |
2800 |
None |
1 |
None |
None |
None |
None |
Estimated average of up to 1,057 prescriptions per month (across all dosage strengths), based on historic IQVIA data, although research suggests that as many as 2,800 Americans take the product annually. Acquisition fields left blank; Teva developed this product. |
None |
| TG Therapeutics, Inc. |
73150020012 |
UKONIQ (umbralisib) 200 mg tablets, 120 count bottle |
2021-02-05 |
15900.0000 |
Marketing Plan:
UKONIQ™ was approved on 2/5/2021 as a kinase inhibitor indicated for the treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based regimen and relapsed or refractory follicular lymphoma (FL) who have received at least three prior lines of systemic therapy. TG has designed marketing activities to raise awareness and understanding with healthcare providers and - in some cases - patients about the approved indications, efficacy and safety data contained within UKONIQ’s FDA approved label.
• UKONIQ will not have any DTC advertisements on any platforms at launch. We will, however, have a patient-facing website that provides information about UKONIQ, the diseases it is approved to treat, and the TG Patient Support Program.
• At launch TG will not offer coupons or free trials. However, at launch TG will offer copayment assistance to commercially insured patients through the TG Patient Support Program. Information about the TG 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.
Pricing Plan:
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. Ahead of our first commercial launch, 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. These guiding principles are inspired by our mission, shaped our pricing decision for UKONIQ and will continue to shine through in our commitment to patients. Further information about our commitment to patient access can be found here: https://www.tgtherapeutics.com/wp-content/uploads/2021/02/Our-Commitment-to-Patient-Access.pdf |
None |
10000 |
1 |
1 |
2012-08-16 |
None |
1 |
The price TG Therapeutics paid for acquisition of the rights to develop and commercialize UKONIQ™ is not shared publicly, and TG Therapeutics has taken reasonable measures to keep this information confidential. Access to the information is limited to certain individuals within the company’s management team and finance functions. The information is subject to non-disclosure requirements in employment agreements. 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: Each year there are approximately 18,000-20,000 patients in the US who are in need of a new treatment for their relapsed disease in both Marginal zone lymphoma (MZL) and Follicular lymphoma (FL). Although difficult to estimate precisely, we believe there are ~8,000-10,000 patients within our FDA labelled indications. |
None |