Apotex's ruxolitinib FDA submission date
Apotex submitted its abbreviated new drug application (ANDA) for a generic version of ruxolitinib (Jakafi) to the FDA on December 23, 2022.[1]
What paragraph does Apotex's ANDA fall under?
Apotex received Paragraph IV certification, challenging Incyte's patents on ruxolitinib, which triggered a 30-month stay on FDA approval.[1][2]
When does the 30-month stay end?
The stay expires on June 23, 2025, barring any court rulings shortening it.[1]
Patent challenges and litigation status
Incyte sued Apotex in the U.S. District Court for the District of Delaware over patents '638, '730, and '525. The case (1:23-cv-00182) remains ongoing, with no final ruling yet.[2]
Other generics in the pipeline
- Sandoz: Submitted November 2022 (Paragraph IV), litigation ongoing.[2]
- Celltrion: Submitted June 2023.[2]
First generic entry depends on patent settlements or losses, likely post-2025.[1]
Ruxolitinib patent expiry details
Key patents expire in 2027 (composition) and 2031 (extended formulations). Pediatric exclusivity adds six months.[3] Check DrugPatentWatch.com for full listings.
[1]: FDA Orange Book (ANDA 217747).
[2]: U.S. District Court, Delaware (1:23-cv-00182).
[3]: DrugPatentWatch.com, Jakafi patents.