Tofacitinib - Generic Drug Details
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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 |
Generic filers with tentative approvals for TOFACITINIB
| Applicant | Application No. | Strength | Dosage Form |
| ⤷ Try for Free | ⤷ Try for Free | 5MG | TABLET;ORAL |
| ⤷ Try for Free | ⤷ Try for Free | EQ 5MG BASE | TABLET;ORAL |
| ⤷ Try for Free | ⤷ Try for Free | 5MG | TABLET;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pfizer | XELJANZ | tofacitinib citrate | SOLUTION;ORAL | 213082-001 | Sep 25, 2020 | RX | Yes | Yes | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | ||||
| Pf Prism Cv | XELJANZ | tofacitinib citrate | TABLET;ORAL | 203214-002 | May 30, 2018 | RX | Yes | Yes | RE41783*PED | ⤷ Try for Free | Y | ⤷ Try for Free | |||
| Ajanta Pharma Ltd | TOFACITINIB CITRATE | tofacitinib citrate | TABLET;ORAL | 212943-001 | Jun 1, 2021 | DISCN | No | No | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | ||||
| Zydus Pharms | TOFACITINIB | tofacitinib citrate | TABLET, EXTENDED RELEASE;ORAL | 214264-001 | Aug 19, 2021 | DISCN | No | No | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
