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When did apotex file its ruxolitinib anda with the fda?

According to the information provided, Apotex, a Canadian pharmaceutical company, filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for ruxolitinib, a drug used to treat certain types of blood cancer and bone marrow disorders. However, the exact date of the filing is not specified in the available information.

It is worth noting that, according to, the patent for ruxolitinib, which is marketed under the brand name Jakafi by Incyte Corporation, expired in the United States in November 2020 [1]. This means that other companies, such as Apotex, can now apply for approval to manufacture and sell generic versions of the drug.

In summary, while the exact date of Apotex's ANDA filing for ruxolitinib with the FDA is not provided, it is known that the patent for the drug expired in November 2020, allowing for generic versions of the drug to enter the market.

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Follow-up:   When did Apotex submit ruxolitinib ANDA to FDA? Has Apotex received FDA approval for ruxolitinib ANDA? What is the current status of Apotex's ruxolitinib ANDA with FDA?

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