When did apotex file its anda for ruxolitinib?

Apotex's ANDA Filing Date for Ruxolitinib

Apotex filed its Abbreviated New Drug Application (ANDA) for generic ruxolitinib (the active ingredient in Incyte's Jakafi) on July 24, 2017. This Paragraph IV filing challenged Incyte's patents, triggering a 30-month stay on FDA approval.[1]

Why Did Apotex Target Ruxolitinib Patents?

Apotex's move was part of early generic challenges to Jakafi, approved in 2011 for myelofibrosis. The company alleged Incyte's key patents (covering the compound and methods of use) were invalid or not infringed, seeking first-to-file 180-day exclusivity.[1][2]

Patent Status and Expiry Timeline

Incyte's primary ruxolitinib patents expire in 2027 (U.S. Patent No. 7,598,257), with pediatric extensions pushing some to 2028. Apotex's ANDA faces ongoing litigation; the 30-month stay ended in January 2020, but no generic approval yet due to court rulings upholding validity.[1][3]

[1]: DrugPatentWatch.com - Ruxolitinib Patent Details
[2]: FDA Paragraph IV Database
[3]: CourtListener - Incyte v. Apotex Litigation