Apotex's Ruxolitinib ANDA Filing Date
Apotex filed its Abbreviated New Drug Application (ANDA) for a generic version of ruxolitinib (Jakafi) with the FDA on May 28, 2021.[1][2]
Paragraph IV Certification Details
Apotex's filing included a Paragraph IV certification, challenging Incyte's patents on ruxolitinib phosphate, which triggered a 30-month stay on FDA approval.[1][2] This positioned Apotex as one of the first filers eligible for 180-day generic exclusivity if approved.
Patent Challenges and Timeline
Incyte sued Apotex over U.S. Patents 9,469,636 and 9,815,806 (expiring 2027-2028), with litigation ongoing in the District of Delaware.[2] The 30-month stay ends around November 28, 2023, but final approval depends on patent outcomes.[1]
Other Early Filers
Apotex was the third first-filer after Sandoz (October 23, 2020) and Celgene (October 26, 2020); they share the 180-day exclusivity block.[2]
Current Status and Launch Prospects
No FDA approval yet; tentative approval is pending patent resolution. Generic entry is unlikely before late 2024-2025.[1]
[1]: DrugPatentWatch.com - Ruxolitinib Patent Expiration
[2]: FDA Paragraph IV Patent Settlement List - Ruxolitinib