SORAFENIB TOSYLATE Drug Patent Profile
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When do Sorafenib Tosylate patents expire, and what generic alternatives are available?
Sorafenib Tosylate is a drug marketed by Dr Reddys, Mylan, Teva Pharms Usa Inc, Torrent, and Yabao Pharm. and is included in five NDAs.
The generic ingredient in SORAFENIB TOSYLATE is sorafenib tosylate. There are thirteen drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the sorafenib tosylate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Sorafenib Tosylate
A generic version of SORAFENIB TOSYLATE was approved as sorafenib tosylate by MYLAN on September 10th, 2020.
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Questions you can ask:
- What is the 5 year forecast for SORAFENIB TOSYLATE?
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- What is Average Wholesale Price for SORAFENIB TOSYLATE?
Summary for SORAFENIB TOSYLATE
| US Patents: | 0 |
| Applicants: | 5 |
| NDAs: | 5 |
| Finished Product Suppliers / Packagers: | 7 |
| Raw Ingredient (Bulk) Api Vendors: | 117 |
| Clinical Trials: | 164 |
| Patent Applications: | 8 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for SORAFENIB TOSYLATE |
| DailyMed Link: | SORAFENIB TOSYLATE at DailyMed |
Recent Clinical Trials for SORAFENIB TOSYLATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Third Affiliated Hospital, Sun Yat-Sen University | Phase 2/Phase 3 |
| Southern Medical University, China | Phase 2/Phase 3 |
| Jiangxi Province Children's Hospital | Phase 2/Phase 3 |
Pharmacology for SORAFENIB TOSYLATE
| Drug Class | Kinase Inhibitor |
| Mechanism of Action | Protein Kinase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for SORAFENIB TOSYLATE
Paragraph IV (Patent) Challenges for SORAFENIB TOSYLATE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| NEXAVAR | Tablets | sorafenib tosylate | 200 mg | 021923 | 1 | 2014-02-28 |
US Patents and Regulatory Information for SORAFENIB TOSYLATE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Dr Reddys | SORAFENIB TOSYLATE | sorafenib tosylate | TABLET;ORAL | 216073-001 | Jun 7, 2022 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Torrent | SORAFENIB TOSYLATE | sorafenib tosylate | TABLET;ORAL | 217095-001 | Apr 12, 2023 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Mylan | SORAFENIB TOSYLATE | sorafenib tosylate | TABLET;ORAL | 207012-001 | Sep 10, 2020 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
