TOFACITINIB Drug Patent Profile
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Which patents cover Tofacitinib, and what generic alternatives are available?
Tofacitinib is a drug marketed by Auson, Hikma, MSN, Saptalis Pharms, Sun Pharm Inds Inc, Ajanta Pharma Ltd, Apotex, Aurobindo Pharma Ltd, Biocon Pharma, Dexcel, Orient Pharma, Sinotherapeutics Inc, Zydus Pharms, Breckenridge, Concord Biotech Ltd, Macleods Pharms Ltd, Micro Labs, Somerset Theraps Llc, Specgx Llc, and Yaopharma Co Ltd. and is included in twenty-five NDAs.
The generic ingredient in TOFACITINIB is tofacitinib citrate. There are twelve drug master file entries for this compound. Twenty-one 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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Summary for TOFACITINIB
| US Patents: | 0 |
| Applicants: | 20 |
| NDAs: | 25 |
| 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 |
| The Fourth Affiliated Hospital of Zhejiang University School of Medicine | NA |
Pharmacology for TOFACITINIB
| Drug Class | Janus Kinase Inhibitor |
| Mechanism of Action | Janus Kinase Inhibitors |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specgx Llc | TOFACITINIB CITRATE | tofacitinib citrate | TABLET;ORAL | 219395-001 | Jun 3, 2026 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Msn | TOFACITINIB CITRATE | tofacitinib citrate | TABLET;ORAL | 217299-001 | Jun 3, 2026 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Specgx Llc | TOFACITINIB CITRATE | tofacitinib citrate | TABLET;ORAL | 219395-002 | Jun 3, 2026 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Msn | TOFACITINIB CITRATE | tofacitinib citrate | TABLET;ORAL | 217299-002 | Jun 3, 2026 | 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 |
