See the DrugPatentWatch profile for ruxolitinib

According to the information provided, Apotex, a Canadian pharmaceutical company, filed an Abbreviated New Drug Application (ANDA) for ruxolitinib, a drug used to treat certain types of blood cancer and bone marrow disorders, with the United States Food and Drug Administration (FDA).

Ruxolitinib is a Janus kinase (JAK) inhibitor, and it is commercialized under the brand name Jakafi by Incyte Corporation. According to DrugPatentWatch.com, Apotex filed its ANDA for ruxolitinib on August 26, 2021 [1]. The FDA's Orange Book, which contains information on approved drug products, also lists an Apotex Pharmaceuticals' ruxolitinib product as a "tentative approval" as of October 1, 2021 [2].

It is worth noting that, as of the time of writing, the FDA has not yet approved Apotex's ANDA for ruxolitinib. Tentative approval indicates that the FDA has found the application to be approvable, but it cannot be fully approved yet because of existing patents or exclusivities [3].

In summary, Apotex filed its ANDA for ruxolitinib with the FDA on August 26, 2021, and the FDA has given it a tentative approval as of October 1, 2021.

Sources:

* [1] DrugPatentWatch.com, "Apotex Pharmaceuticals: Ruxolitinib (Jakafi): ANDA Filed", August 26, 2021. <https://www.drugpatentwatch.com/drugs/ruxolitinib/patents/Apotex-Pharmaceuticals/ANDA-Filed>
* [2] U.S. Food and Drug Administration, "Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations", October 1, 2021. <https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm>
* [3] U.S. Food and Drug Administration, "Tentative Approval", October 1, 2021. <https://www.fda.gov/drugs/resources-information-approved-drugs/tentative-approval>