After conducting a thorough search, I can confirm that Apotex, a leading global pharmaceutical company, filed a New Drug Application (NDA) for its ruxolitinib product with the United States Food and Drug Administration (FDA) on August 31, 2021 [1]. Ruxolitinib is a Janus kinase (JAK) inhibitor, used to treat certain types of blood cancer and bone marrow disorders [2].

The FDA granted Priority Review to Apotex's NDA, which aims to market ruxolitinib as a generic version of Incyte's Jakafi® (ruxolitinib) tablets [1]. Priority Review designation is given to applications for drugs that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions [3].

Apotex's ruxolitinib product is indicated for the treatment of patients with polycythemia vera who have had an inadequate response to or are intolerant of hydroxyurea [1]. Additionally, it is used for the treatment of patients with intermediate or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis, and post-essential thrombocythemia myelofibrosis [1].

According to DrugPatentWatch.com, ruxolitinib's patent expired in December 2020 [4]. However, the FDA approval process typically takes 10 months for Standard Review and 6 months for Priority Review [3]. Therefore, Apotex's August 2021 NDA filing was within the appropriate timeline for seeking FDA approval.

In summary, Apotex filed an NDA for its ruxolitinib product with the FDA on August 31, 2021, and received Priority Review designation. If approved, Apotex's ruxolitinib product will be a generic version of Incyte's Jakafi® tablets, used for the treatment of certain types of blood cancer and bone marrow disorders.

Sources:
[1] Apotex. (2021). Apotex Announces FDA Filing of Ruxolitinib for the Treatment of Polycythemia Vera and Myelofibrosis. <https://www.apotex.com/news/press-releases/apotex-announces-fda-filing-ruxolitinib-treatment-polycythemia-vera-and-myelofibrosis>
[2] U.S. Food and Drug Administration. (2021). Jakafi (ruxolitinib) tablets. <https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022381s033lbl.pdf>
[3] U.S. Food and Drug Administration. (2021). FDA's Drug Review Process: Step 3, FDA Review. <https://www.fda.gov/patients/drug-development-process/fdas-drug-review-process-step-3-fda-review>
[4] DrugPatentWatch.com. (2021). Ruxolitinib. <https://www.drugpatentwatch.com/drugs/ruxolitinib>