TOFACITINIB Drug Patent Profile
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Which patents cover Tofacitinib, and what generic alternatives are available?
Tofacitinib is a drug marketed by Hikma, Ajanta Pharma Ltd, Aurobindo Pharma Ltd, Biocon Pharma, Dexcel, Sinotherapeutics Inc, Zydus Pharms, and Micro Labs. and is included in ten NDAs.
The generic ingredient in TOFACITINIB is tofacitinib citrate. There are twelve drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the tofacitinib citrate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Tofacitinib
A generic version of TOFACITINIB was approved as tofacitinib citrate by AJANTA PHARMA LTD on June 1st, 2021.
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Questions you can ask:
- What is the 5 year forecast for TOFACITINIB?
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- What is Average Wholesale Price for TOFACITINIB?
Summary for TOFACITINIB
| US Patents: | 0 |
| Applicants: | 8 |
| NDAs: | 10 |
| DailyMed Link: | TOFACITINIB at DailyMed |
Recent Clinical Trials for TOFACITINIB
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Hexsel Dermatology Clinic | PHASE2 |
| National Institute of Dental and Craniofacial Research (NIDCR) | PHASE2 |
| University of California, San Francisco | PHASE4 |
US Patents and Regulatory Information for TOFACITINIB
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hikma | TOFACITINIB CITRATE | tofacitinib citrate | SOLUTION;ORAL | 216878-001 | Sep 25, 2023 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Zydus Pharms | TOFACITINIB CITRATE | tofacitinib citrate | TABLET, EXTENDED RELEASE;ORAL | 214264-001 | Aug 19, 2021 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Biocon Pharma | TOFACITINIB CITRATE | tofacitinib citrate | TABLET, EXTENDED RELEASE;ORAL | 219442-001 | Nov 17, 2025 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Zydus Pharms | TOFACITINIB CITRATE | tofacitinib citrate | TABLET, EXTENDED RELEASE;ORAL | 214264-002 | Aug 19, 2021 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
