Apotex's Ruxolitinib ANDA Filing Date
Apotex filed its Abbreviated New Drug Application (ANDA) for a generic version of ruxolitinib (Jakafi) with the U.S. FDA on December 28, 2018.[1]
Why This Filing Matters
This date triggered the 30-month stay under Hatch-Waxman, delaying FDA approval until at least June 28, 2021, amid ongoing patent litigation with Incyte and Novartis. The case, Incyte Corp. v. Apotex Inc., remains active in federal court.[1][2]
Patent Status and Expiry
Ruxolitinib's key U.S. patents (e.g., 7,598,257 for the compound) expire in 2027, with pediatric exclusivity potentially extending to 2030. Apotex challenged validity via Paragraph IV certification. Check detailed patent timelines at DrugPatentWatch.com.[1][3]
Other Generic Challengers
Apotex was among the first filers; others like Sandoz (January 2019) and Celltrion (2020) followed. No generics approved yet due to litigation.[2]
Current Market and Patient Impact
Jakafi (Incyte/Novartis) holds exclusivity; generics could cut costs from ~$12,000/month. Patients face delays, but settlements may allow limited entry post-2027.[3]
Sources:
[1]: FDA Orange Book - Ruxolitinib Patents and Exclusivities
[2]: CourtListener - Incyte v. Apotex Docket
[3]: DrugPatentWatch.com - Jakafi Patent Details