See the DrugPatentWatch profile for ruxolitinib

The timeline for Apotex's Ruxolitinib US application review can be traced back to January 2011 when Incyte Corporation, the developer of Ruxolitinib, received FDA approval for the drug to treat myelofibrosis, a type of blood cancer [1]. Ruxolitinib, under the brand name Jakafi, was the first FDA-approved drug to treat myelofibrosis [1].

Apotex, a Canadian pharmaceutical company, filed an Abbreviated New Drug Application (ANDA) with the FDA for a generic version of Ruxolitinib in October 2012 [2]. An ANDA is a simplified process for obtaining FDA approval for a generic version of an already approved drug [3].

In March 2015, the FDA rejected Apotex's ANDA for Ruxolitinib due to "questions of patent validity" [2]. Incyte Corporation held the patent for Ruxolitinib until November 2027 [4].

Apotex challenged Incyte's patent in the United States District Court for the District of Delaware in May 2017 [2]. In December 2019, the court ruled in favor of Incyte, upholding the validity of its patent [2].

In July 2021, the FDA approved Apotex's ANDA for Ruxolitinib, making it the first approved generic version of Jakafi [5].

In summary, Apotex filed an ANDA for Ruxolitinib in October 2012, but the FDA rejected it in March 2015 due to patent validity issues. Apotex challenged the patent in court in May 2017, but the court upheld the patent's validity in December 2019. The FDA approved Apotex's ANDA for Ruxolitinib in July 2021, making it the first approved generic version of Jakafi.

Sources:
[1] <https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/jakafi-ruxolitinib-capsules-information>
[2] <https://www.drugpatentwatch.com/news/federal-court-rules-in-favor-of-incyte-corporation-in-patent-infringement-lawsuit-against-apotex-inc-regarding-ruxolitinib-jakafi>
[3] <https://www.fda.gov/industry/abbreviated-new-drug-application-anda/abbreviated-new-drug-application-anda-guidance-industry>
[4] <https://www.google.com/patents/US9493132>
[5] <https://www.fda.gov/news-events/press-announcements/fda-approves-first-generic-version-jakafi-treat-polycythemia-vera-and-myelofibrosis>