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When did apotex submit ruxolitinib anda to fda?

See the DrugPatentWatch profile for ruxolitinib

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



Other Questions About Ruxolitinib :  Can you specify the exact date of apotex's ruxolitinib anda submission in the us? Can you provide more details about apotex's ruxolitinib anda filing? Can you confirm apotex's ruxolitinib us filing date? When did apotex receive usa approval for ruxolitinib? How does combining ruxolitinib and azacitidine affect treatment outcomes? When will apotex's ruxolitinib become available in usa? What specific challenges caused apotex's ruxolitinib's fda approval delay?





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