TOFACITINIB Drug Patent Profile
✉ Email this page to a colleague
Which patents cover Tofacitinib, and what generic alternatives are available?
Tofacitinib is a drug marketed by Hikma, MSN, Pharmaco, Saptalis Pharms, Sun Pharm Inds Inc, Ajanta Pharma Ltd, Apotex, Aurobindo Pharma Ltd, Biocon Pharma, Dexcel, Orient Pharma, Sciegen Pharms, Sinotherapeutics Inc, Teva Pharms Usa, Zydus Pharms, Breckenridge, Concord Biotech Ltd, Macleods Pharms, Micro Labs, Somerset Theraps Llc, Specgx Llc, and Yaopharma Co Ltd. and is included in twenty-seven NDAs.
The generic ingredient in TOFACITINIB is tofacitinib citrate. There is one drug master file entry for this compound. Twenty-eight 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.
AI Deep Research
Questions you can ask:
- What is the 5 year forecast for TOFACITINIB?
- What are the global sales for TOFACITINIB?
- What is Average Wholesale Price for TOFACITINIB?
Summary for TOFACITINIB
| US Patents: | 0 |
| Applicants: | 22 |
| NDAs: | 27 |
| 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 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Msn | TOFACITINIB CITRATE | tofacitinib citrate | TABLET;ORAL | 217299-002 | Jun 3, 2026 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Macleods Pharms | TOFACITINIB CITRATE | tofacitinib citrate | TABLET;ORAL | 219530-002 | Jun 3, 2026 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Somerset Theraps Llc | TOFACITINIB CITRATE | tofacitinib citrate | TABLET;ORAL | 220137-001 | Jun 3, 2026 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Micro Labs | TOFACITINIB CITRATE | tofacitinib citrate | TABLET;ORAL | 209738-001 | Mar 13, 2023 | 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 |
