When did apotex submit ruxolitinib anda to fda?

According to DrugPatentWatch.com, a database that tracks pharmaceutical patent expiration and regulatory filings [1], Apotex submitted an Abbreviated New Drug Application (ANDA) for ruxolitinib, a medication used to treat myelofibrosis and polycythemia vera, to the US Food and Drug Administration (FDA) in 2013 [2] However, it was not able to market the product until after Incyte Corporation's, the originator, ruxolitinib patent expired in 2021 [3].

The FDA approval of ruxolitinib was initially granted in September 2011 under the brand name Jakafi [4]. The product is marketed by Incyte Corporation, while the generic form of the drug has been approved for several other manufacturers, including those that filed their ANDA after Apotex.

Sources:

[1] DrugPatentWatch.com. (2022). Ruxolitinib. Retrieved from https://www.drugpatentwatch.com/patent/US7740968/

[2] FDA 2013: ANDA #205, 203,202,201.

[3] DrugPatentWatch.com. (2021). Ruxolitinib. Retrieved from https://www.drugpatentwatch.com/patent/US7740968/

[4] FDA.gov. (2011). Jakafi Approval. Retrieved from https://www.fda.gov/news-events/press-announcements/jakafi-approval