TOFACITINIB CITRATE Drug Patent Profile
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Which patents cover Tofacitinib Citrate, and what generic alternatives are available?
Tofacitinib Citrate is a drug marketed by Hikma, Ajanta Pharma Ltd, Micro Labs, and Zydus Pharms. and is included in four NDAs.
The generic ingredient in TOFACITINIB CITRATE 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 Citrate
A generic version of TOFACITINIB CITRATE was approved as tofacitinib citrate by HIKMA on September 25th, 2023.
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Summary for TOFACITINIB CITRATE
| US Patents: | 0 |
| Applicants: | 4 |
| NDAs: | 4 |
| Raw Ingredient (Bulk) Api Vendors: | 90 |
| Clinical Trials: | 10 |
| Patent Applications: | 106 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for TOFACITINIB CITRATE |
| DailyMed Link: | TOFACITINIB CITRATE at DailyMed |
Recent Clinical Trials for TOFACITINIB CITRATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| China-Japan Friendship Hospital | Phase 4 |
| CAGE Bio Inc. | Phase 1/Phase 2 |
| Services Institute of Medical Sciences, Pakistan | Early Phase 1 |
Anatomical Therapeutic Chemical (ATC) Classes for TOFACITINIB CITRATE
Paragraph IV (Patent) Challenges for TOFACITINIB CITRATE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| XELJANZ | Oral Solution | tofacitinib citrate | 1 mg/mL | 213082 | 1 | 2021-11-12 |
| XELJANZ XR | Extended-release Tablets | tofacitinib citrate | 22 mg | 208246 | 1 | 2020-12-28 |
| XELJANZ | Tablets | tofacitinib citrate | 10 mg | 203214 | 1 | 2019-07-24 |
| XELJANZ | Tablets | tofacitinib citrate | 5 mg | 203214 | 3 | 2016-11-07 |
| XELJANZ XR | Extended-release Tablets | tofacitinib citrate | 11 mg | 208246 | 1 | 2016-11-07 |
US Patents and Regulatory Information for TOFACITINIB CITRATE
| 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 | AA | RX | 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 | ||||
| Ajanta Pharma Ltd | TOFACITINIB CITRATE | tofacitinib citrate | TABLET;ORAL | 212943-001 | Jun 1, 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 |
