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Last Updated: December 18, 2025

Tofacitinib - Generic Drug Details

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Recent Clinical Trials for tofacitinib

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University Hospital, Brest	PHASE3
Eli Lilly and Company	PHASE3
Hayat Abad Medical Complex, Peshawar.	EARLY_PHASE1

See all tofacitinib clinical trials

Generic filers with tentative approvals for TOFACITINIB

Applicant	Application No.	Strength	Dosage Form
⤷ Get Started Free	⤷ Get Started Free	5MG	TABLET;ORAL
⤷ Get Started Free	⤷ Get Started Free	EQ 5MG BASE	TABLET;ORAL
⤷ Get Started Free	⤷ Get Started 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

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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
Micro Labs	TOFACITINIB CITRATE	tofacitinib citrate	TABLET;ORAL	209738-001	Mar 13, 2023		DISCN	No	No	⤷ Get Started Free	⤷ Get Started Free				⤷ Get Started Free
Pf Prism Cv	XELJANZ	tofacitinib citrate	TABLET;ORAL	203214-001	Nov 6, 2012		RX	Yes	No	RE41783*PED	⤷ Get Started Free			Y	⤷ Get Started Free
Zydus Pharms	TOFACITINIB CITRATE	tofacitinib citrate	TABLET, EXTENDED RELEASE;ORAL	214264-002	Aug 19, 2021		DISCN	No	No	⤷ Get Started Free	⤷ Get Started Free				⤷ Get Started Free
Pfizer	XELJANZ	tofacitinib citrate	SOLUTION;ORAL	213082-001	Sep 25, 2020		RX	Yes	Yes	⤷ Get Started Free	⤷ Get Started Free				⤷ Get Started Free
Pfizer	XELJANZ	tofacitinib citrate	SOLUTION;ORAL	213082-001	Sep 25, 2020		RX	Yes	Yes	⤷ Get Started Free	⤷ Get Started Free				⤷ Get Started Free
Pfizer	XELJANZ XR	tofacitinib citrate	TABLET, EXTENDED RELEASE;ORAL	208246-002	Dec 12, 2019		RX	Yes	Yes	10,639,309*PED	⤷ Get Started Free			Y	⤷ Get Started Free
Pfizer	XELJANZ XR	tofacitinib citrate	TABLET, EXTENDED RELEASE;ORAL	208246-002	Dec 12, 2019		RX	Yes	Yes	11,253,523*PED	⤷ Get Started Free			Y	⤷ Get Started Free
>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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