TOFACITINIB Drug Patent Profile
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Which patents cover Tofacitinib, and what generic alternatives are available?
Tofacitinib is a drug marketed by Aurobindo Pharma Ltd, Zydus Pharms, Hikma, Ajanta Pharma Ltd, and Micro Labs. and is included in six 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 HIKMA on September 25th, 2023.
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Summary for TOFACITINIB
| US Patents: | 0 |
| Applicants: | 5 |
| NDAs: | 6 |
| Raw Ingredient (Bulk) Api Vendors: | 120 |
| Clinical Trials: | 132 |
| Patent Applications: | 2,028 |
| DailyMed Link: | TOFACITINIB at DailyMed |
Recent Clinical Trials for TOFACITINIB
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Takeda | Phase 4 |
| Zhejiang University | Phase 3 |
| Hangzhou Highlightll Pharmaceutical Co., Ltd | Phase 3 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Aurobindo Pharma Ltd | TOFACITINIB | tofacitinib citrate | TABLET, EXTENDED RELEASE;ORAL | 218462-001 | Jun 3, 2024 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Zydus Pharms | TOFACITINIB CITRATE | tofacitinib citrate | TABLET;ORAL | 209829-001 | Mar 13, 2023 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Hikma | TOFACITINIB CITRATE | tofacitinib citrate | SOLUTION;ORAL | 216878-001 | Sep 25, 2023 | AA | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Zydus Pharms | TOFACITINIB | tofacitinib citrate | TABLET, EXTENDED RELEASE;ORAL | 214264-001 | Aug 19, 2021 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Zydus Pharms | TOFACITINIB | tofacitinib citrate | TABLET, EXTENDED RELEASE;ORAL | 214264-002 | Aug 19, 2021 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Micro Labs | TOFACITINIB CITRATE | tofacitinib citrate | TABLET;ORAL | 209738-001 | Mar 13, 2023 | DISCN | 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 |
