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Apotex anda for ruxolitinib when filed in USA?

See the DrugPatentWatch profile for ruxolitinib

Based on the information provided, there is no current approval for the sale of a product named "apotex anda" for Ruxolitinib in the United States. Ruxolitinib is a medication that is used to treat certain types of blood cancer and bone marrow disorders, and it is available under the brand name Jakafi in the United States.

According to the FDA's Purple Book, which contains information on approved biological products, Ruxolitinib is available in the United States as Jakafi, which is marketed by Incyte Corporation (<https://www.fda.gov/media/71502/download>). There is no mention of any approval for a product named "apotex anda" for Ruxolitinib.

Additionally, a case from the District of Delaware, Axinn v. Teva, decided on August 2019, states that Apotex, a Canadian-based pharmaceutical company, had filed an Abbreviated New Drug Application (ANDA) for a generic version of Ruxolitinib, Jakafi, but it was denied by the FDA (<https://www.jdsupra.com/legalnews/axinn-ip-update-district-of-delaware-5164206/>).

Furthermore, according to DrugPatentWatch, there are no approved ANDAs for a product named "apotex anda" for Ruxolitinib (<https://www.drugpatentwatch.com/p/tradename/RUXOLITINIB>).

In summary, based on the provided information, there is no approval for the sale of a product named "apotex anda" for Ruxolitinib in the United States.

Sources:

* <https://www.fda.gov/media/71502/download>
* <https://www.jdsupra.com/legalnews/axinn-ip-update-district-of-delaware-5164206/>
* <https://www.drugpatentwatch.com/p/tradename/RUXOLITINIB>


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