Apotex, a Canadian pharmaceutical company, submitted an Abbreviated New Drug Application (ANDA) for the active pharmaceutical ingredient (API) ruxolitinib to the US Food and Drug Administration (FDA) [1]. However, the status and outcome of this filing are unclear.
According to DrugPatentWatch.com [2], ruxolitinib is the active ingredient in several branded products, including Jakafi, developed by Incyte Corporation. Jakafi was approved by the FDA in 2011 for the treatment of certain types of myeloproliferative neoplasms.
The patent landscape for ruxolitinib is complex, with multiple patents listed by Incyte Corporation that, if enforced, could block generic competition to Jakafi in various markets. However, the ANDA filed by Apotex would likely challenge the exclusivity of these patents and seek FDA approval for a generic version of ruxolitinib.
The exact details about the Apotex ANDA filing for ruxolitinib are not publicly available. The FDA's website provides information on approved ANDAs, but it does not typically disclose information on pending applications. The Apotex website does not provide any updates on their efforts to gain FDA approval for a generic version of ruxolitinib.
Sources:
[1] U.S. Food and Drug Administration (FDA): Abbreviated New Drug Application (ANDA) [https://www.fda.gov/drugs/development-approval-process/abbreviated-new-drug-application-anda]
[2] DrugPatentWatch.com: Ruxolitinib [https://www.drugpatentwatch.com/patent/US7846517]