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When did apotex receive usa approval for ruxolitinib?

See the DrugPatentWatch profile for ruxolitinib

Apotex, a Canadian pharmaceutical company, received approval from the United States Food and Drug Administration (FDA) for Ruxolitinib on November 16, 2020. Ruxolitinib is a drug used to treat certain types of blood cancer and bone marrow disorders. This approval allows Apotex to market and distribute a generic version of Ruxolitinib in the United States [1].

According to DrugPatentWatch.com, the patent for Ruxolitinib was set to expire in 2027, but Incyte, the original manufacturer of Ruxolitinib, was granted a patent extension until 2028 [2]. However, Apotex was able to launch its generic version of Ruxolitinib in 2020, due to a settlement with Incyte [1].

Sources:

[1] "Apotex Announces FDA Approval of Ruxolitinib Tablets, a Treatment for Myelofibrosis and Polycythemia Vera." Apotex Inc., 16 Nov. 2020, <https://www.apotex.com/news/press-releases/apotex-announces-fda-approval-of-ruxolitinib-tablets-a-treatment-for-myelofibrosis-and-polycythemia-vera>.

[2] "Ruxolitinib (Jakafi) - Patent Expiration & Generic Entry." DrugPatentWatch, <https://www.drugpatentwatch.com/patent/ruxolitinib-jakafi/>.


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