Last Updated: August 17, 2026

Ruxolitinib - Generic Drug Details

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Generic filers with tentative approvals for RUXOLITINIB

Applicant	Application No.	Strength	Dosage Form
⤷ Start Trial	⤷ Start Trial	2MG	TABLET; ORAL
⤷ Start Trial	⤷ Start Trial	15MG	TABLET; ORAL
⤷ Start Trial	⤷ Start Trial	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	JAKAFI XR	ruxolitinib phosphate	TABLET, EXTENDED RELEASE;ORAL	217180-004	May 1, 2026		RX	Yes	No	8,822,481*PED	⤷ Start Trial			Y	⤷ Start Trial
Incyte Corp	JAKAFI	ruxolitinib phosphate	TABLET;ORAL	202192-005	Nov 16, 2011		RX	Yes	Yes	9,814,722*PED	⤷ Start Trial			Y	⤷ Start Trial
Incyte Corp	JAKAFI	ruxolitinib phosphate	TABLET;ORAL	202192-005	Nov 16, 2011		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Incyte Corp	JAKAFI	ruxolitinib phosphate	TABLET;ORAL	202192-004	Nov 16, 2011		RX	Yes	No	8,415,362*PED	⤷ Start Trial			Y	⤷ Start Trial
Incyte Corp	JAKAFI XR	ruxolitinib phosphate	TABLET, EXTENDED RELEASE;ORAL	217180-005	May 1, 2026		RX	Yes	Yes	8,415,362*PED	⤷ Start Trial			Y	⤷ 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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