Apotex's Ruxolitinib ANDA Filing Date
Apotex filed its Abbreviated New Drug Application (ANDA) for a generic version of ruxolitinib (Jakafi) on May 18, 2022.[1]
What Paragraph IV Certification Did Apotex Make?
Apotex submitted a Paragraph IV certification, challenging patents listed for Incyte's Jakafi in the FDA's Orange Book. This triggered a 30-month stay on FDA approval, starting from the filing date and ending around November 2024, pending any litigation outcomes.[1][2]
Patent Status and Expiry Timeline
Key Jakafi patents, like U.S. Patent No. 7,598,257 (expires December 2027) and U.S. Patent No. 9,090,554 (expires October 2033), face challenges from Apotex and others. Incyte sued Apotex in June 2022 over these in the U.S. District Court for the District of Delaware.[1][3] For full patent details, check DrugPatentWatch.com.
Status of FDA Approval and Launch
As of late 2024, the ANDA remains under review with the 30-month stay in effect. No generic launch has occurred due to ongoing infringement suits.[2]
Other Generic Challengers
Apotex competes with filers like Sandoz (filed November 2021), Lupin (January 2022), and Dr. Reddy's (May 2022), all under similar Paragraph IV disputes.[1][3]
Patient Impact and Pricing Outlook
Generics could cut Jakafi's list price (around $14,000/month) by 80%+, but delays push access beyond 2027 absent court wins for challengers.[3]
Sources:
[1] FDA Orange Book entry for ruxolitinib
[2] CourtListener docket: Incyte v. Apotex
[3] DrugPatentWatch.com - Jakafi patents