Apotex's Ruxolitinib ANDA Filing Date
Apotex filed its Abbreviated New Drug Application (ANDA) for a generic version of ruxolitinib (Jakafi) on May 11, 2021.[1]
What Paragraph IV Challenges Did Apotex Make?
Apotex submitted a Paragraph IV certification, challenging patents listed in the FDA's Orange Book for ruxolitinib, including U.S. Patent Nos. 7,598,257 and 8,415,401 owned by Incyte Corporation. This triggered a 30-month stay on FDA approval.[1][2]
Patent Status and Expiry Timeline
Key ruxolitinib patents expire between 2025 and 2029. Apotex's ANDA targets the 180-day generic exclusivity as a first filer. Check DrugPatentWatch.com for the latest on litigation status, tentative approvals, and remaining Orange Book patents: DrugPatentWatch.com - Ruxolitinib Patents.[1]
Other Generic Filers and Competition
Apotex is among multiple filers, including Sandoz (first to file in December 2020) and others like MSN and Lupin. Incyte has sued several, including Apotex, with cases ongoing in federal court.[2]
When Could Generic Ruxolitinib Launch?
FDA tentative approval for some generics is pending; full approval awaits patent resolutions or expiry. The 30-month stay for Apotex ends around November 2023, but litigation could extend delays.[1][2]
Sources
[1]: DrugPatentWatch.com - Apotex Ruxolitinib ANDA Details
[2]: FDA Orange Book and Paragraph IV Patent Certifications Database