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Tentative Approval — This application has been tentatively approved by the FDA but is not yet listed in the Orange Book. It is blocked from final approval by unexpired patents or exclusivities on the reference listed drug.

Ruxolitinib

NDA

Tentative Approval

Ruxolitinib | N219660 | APOTEX

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
INCYTE CORP. et al v. APOTEX INC. 1:2025cv04044 5 patentsruxolitinib	D.N.J.	2025-05-08	Terminated 2025-11-12	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Nov 24, 2025	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#002 — 10MG

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TABLET; ORAL | TA Date: 2025-11-21 00:00:00

No patent or exclusivity listings for this strength.

#003 — 15MG

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TABLET; ORAL | TA Date: 2025-11-21 00:00:00

#004 — 2MG

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TABLET; ORAL | TA Date: 2025-11-21 00:00:00