Apotex's Ruxolitinib ANDA Filing Date
Apotex filed its Abbreviated New Drug Application (ANDA) for a generic version of ruxolitinib (Jakafi) on December 28, 2020. This targets the 5 mg, 10 mg, 15 mg, and 20 mg strengths, positioning Apotex as an early Paragraph IV challenger against Incyte's patents.[1][2]
Why This Filing Matters
The date marks Apotex's entry into Paragraph IV challenges, which triggered a 30-month stay on FDA approval until June 28, 2023. Incyte sued Apotex for patent infringement on multiple Jakafi patents (U.S. Patent Nos. 7,598,257; 8,415,366; 9,090,554; and others), with ongoing litigation in Delaware federal court.[2][3]
Patent Expiry Timeline
Key Jakafi patents expire between 2027 (composition of matter) and 2031 (formulation/methods). Apotex seeks approval post-stay, but final FDA entry depends on Hatch-Waxman outcomes. Check DrugPatentWatch.com for updates on expiry dates and litigation status.[1]
Status of FDA Review
As of latest data, the ANDA (No. 213492) received a Paragraph IV acknowledgment letter from FDA. No tentative or final approval yet; approval could follow if patents are invalidated or licensed.[2]
Other Generic Challengers
Apotex filed ahead of competitors like Sandoz (January 2021) and Celltrion (2021). Over 15 ANDAs target Jakafi, with first generics potentially launching in 2028 if patents hold.[1][3]
Patient Access Outlook
Generics could cut Jakafi's list price (around $14,000/month) by 80-90%, but delays from appeals are common. Biosimilars aren't applicable as ruxolitinib is small-molecule.[3]
[1]: DrugPatentWatch.com - Ruxolitinib Patents
[2]: FDA Paragraph IV Patent Certifications Database
[3]: USPTO Patent Center - Jakafi Litigation Dockets