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Last Updated: December 31, 2025

Ruxolitinib - Generic Drug Details

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Generic filers with tentative approvals for RUXOLITINIB

Applicant	Application No.	Strength	Dosage Form
⤷ Get Started Free	⤷ Get Started Free	2MG	TABLET; ORAL
⤷ Get Started Free	⤷ Get Started Free	15MG	TABLET; ORAL
⤷ Get Started Free	⤷ Get Started Free	10MG	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 ruxolitinib

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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
Incyte Corp	OPZELURA	ruxolitinib phosphate	CREAM;TOPICAL	215309-001	Sep 21, 2021		RX	Yes	Yes	⤷ Get Started Free	⤷ Get Started Free				⤷ Get Started Free
Incyte Corp	OPZELURA	ruxolitinib phosphate	CREAM;TOPICAL	215309-001	Sep 21, 2021		RX	Yes	Yes	10,869,870*PED	⤷ Get Started Free			Y	⤷ Get Started Free
Incyte Corp	JAKAFI	ruxolitinib phosphate	TABLET;ORAL	202192-002	Nov 16, 2011		RX	Yes	No	8,722,693*PED	⤷ Get Started Free			Y	⤷ Get Started Free
Incyte Corp	JAKAFI	ruxolitinib phosphate	TABLET;ORAL	202192-005	Nov 16, 2011		RX	Yes	Yes	8,829,013*PED	⤷ Get Started Free			Y	⤷ Get Started Free
Incyte Corp	OPZELURA	ruxolitinib phosphate	CREAM;TOPICAL	215309-001	Sep 21, 2021		RX	Yes	Yes	10,639,310*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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