Apotex submitted its abbreviated new drug application (ANDA) for a generic version of ruxolitinib (referenced to Incyte's Jakafi) to the FDA on February 28, 2020.[1]
This filing triggered a Paragraph IV certification challenge against patents listed for Jakafi in the FDA's Orange Book, leading to patent litigation from Incyte and Novartis.[1][2]
Why does the date matter?
The submission date starts the 30-month stay on FDA approval, potentially delaying generic launch until August 2022 unless resolved earlier by settlement or court ruling. Litigation remains ongoing in districts like Delaware, with Incyte alleging infringement on method-of-use and formulation patents expiring between 2027 and 2032.[2][3]
Patent expiry timeline for Jakafi
Core composition-of-matter patents expired in 2025 (U.S. Patent 7,598,257), but secondary patents extend protection to at least 2031. Check DrugPatentWatch.com for the full Orange Book list and litigation status: DrugPatentWatch.com - Ruxolitinib Patents.[4]
Other generics in the race
Apotex was among the first filers; competitors like Sandoz (submitted April 2020) and Celltrion also face similar suits. No generics approved as of October 2024.[2][3]
Patient impact
Generics could cut Jakafi's $6,000+ monthly cost, but delays keep prices high for myelofibrosis and graft-versus-host disease patients.[5]
Sources:
[1] FDA Paragraph IV Patent Certifications Database (accessdata.fda.gov)
[2] U.S. District Court filings, Incyte v. Apotex (D. Del. 1:20-cv-00644)
[3] RPX Insight litigation tracker
[4] DrugPatentWatch.com
[5] Jakafi prescribing info and pricing data (FDA/IQVIA)