TOFACITINIB Drug Patent Profile
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Which patents cover Tofacitinib, and what generic alternatives are available?
Tofacitinib is a drug marketed by Zydus Pharms, Slayback Pharma Llc, Ajanta Pharma Ltd, and Micro Labs. and is included in five 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 SLAYBACK PHARMA LLC on September 25th, 2023.
Summary for TOFACITINIB
| US Patents: | 0 |
| Applicants: | 4 |
| NDAs: | 5 |
| Raw Ingredient (Bulk) Api Vendors: | 120 |
| Clinical Trials: | 123 |
| Patent Applications: | 2,670 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | TOFACITINIB at DailyMed |
Recent Clinical Trials for TOFACITINIB
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Peking Union Medical College Hospital | Phase 2 |
| Children's Hospital Los Angeles | Phase 2 |
| Nanfang Hospital of Southern Medical University | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for TOFACITINIB
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Zydus Pharms | TOFACITINIB | tofacitinib citrate | TABLET, EXTENDED RELEASE;ORAL | 214264-001 | Aug 19, 2021 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Ajanta Pharma Ltd | TOFACITINIB CITRATE | tofacitinib citrate | TABLET;ORAL | 212943-001 | Jun 1, 2021 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Zydus Pharms | TOFACITINIB | tofacitinib citrate | TABLET, EXTENDED RELEASE;ORAL | 214264-002 | Aug 19, 2021 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Slayback Pharma Llc | TOFACITINIB CITRATE | tofacitinib citrate | SOLUTION;ORAL | 216878-001 | Sep 25, 2023 | AA | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Zydus Pharms | TOFACITINIB CITRATE | tofacitinib citrate | TABLET;ORAL | 209829-001 | Mar 13, 2023 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
