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, Dexcel, Sinotherapeutics Inc, Zydus Pharms, and Micro Labs. and is included in nine NDAs.
The generic ingredient in TOFACITINIB is tofacitinib citrate. There are twelve drug master file entries for this compound. Two 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 August 19th, 2025.
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Summary for TOFACITINIB
| US Patents: | 0 |
| Applicants: | 7 |
| NDAs: | 9 |
| DailyMed Link: | TOFACITINIB at DailyMed |
Recent Clinical Trials for TOFACITINIB
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Eli Lilly and Company | PHASE3 |
| University Hospital, Brest | PHASE3 |
| Hayat Abad Medical Complex, Peshawar. | EARLY_PHASE1 |
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 | ⤷ Get Started Free | ⤷ Get Started Free | ⤷ Get Started Free | ||||
| Zydus Pharms | TOFACITINIB CITRATE | tofacitinib citrate | TABLET, EXTENDED RELEASE;ORAL | 214264-002 | Aug 19, 2021 | DISCN | No | No | ⤷ Get Started Free | ⤷ Get Started Free | ⤷ Get Started Free | ||||
| Dexcel | TOFACITINIB CITRATE | tofacitinib citrate | TABLET, EXTENDED RELEASE;ORAL | 218668-001 | Dec 16, 2024 | DISCN | No | No | ⤷ Get Started Free | ⤷ Get Started Free | ⤷ Get Started Free | ||||
| Ajanta Pharma Ltd | TOFACITINIB CITRATE | tofacitinib citrate | TABLET;ORAL | 212943-001 | Jun 1, 2021 | DISCN | No | No | ⤷ Get Started Free | ⤷ Get Started Free | ⤷ Get Started Free | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
