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Last Updated: April 16, 2026

Tofacitinib - Generic Drug Details

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Recent Clinical Trials for tofacitinib

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Sponsor	Phase
Hexsel Dermatology Clinic	PHASE2
National Institute of Dental and Craniofacial Research (NIDCR)	PHASE2
University of California, San Francisco	PHASE4

See all tofacitinib clinical trials

Generic filers with tentative approvals for TOFACITINIB

Applicant	Application No.	Strength	Dosage Form
⤷ Start Trial	⤷ Start Trial	5MG	TABLET;ORAL
⤷ Start Trial	⤷ Start Trial	EQ 5MG BASE	TABLET;ORAL
⤷ Start Trial	⤷ Start Trial	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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	XELJANZ XR	tofacitinib citrate	TABLET, EXTENDED RELEASE;ORAL	208246-001	Feb 23, 2016	AB	RX	Yes	No	⤷ Start Trial	⤷ Start Trial			Y	⤷ Start Trial
Pfizer	XELJANZ XR	tofacitinib citrate	TABLET, EXTENDED RELEASE;ORAL	208246-002	Dec 12, 2019		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial			Y	⤷ Start Trial
Pf Prism Cv	XELJANZ	tofacitinib citrate	TABLET;ORAL	203214-002	May 30, 2018		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial			Y	⤷ Start Trial
Pf Prism Cv	XELJANZ	tofacitinib citrate	TABLET;ORAL	203214-001	Nov 6, 2012		RX	Yes	No	⤷ Start Trial	⤷ Start Trial			Y	⤷ Start Trial
Ajanta Pharma Ltd	TOFACITINIB CITRATE	tofacitinib citrate	TABLET, EXTENDED RELEASE;ORAL	219542-001	Aug 19, 2025		DISCN	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

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