See the DrugPatentWatch profile for ruxolitinib
Based on the information available, I was unable to find an exact FDA submission date for Apotex's Ruxolitinib. However, Ruxolitinib is a Janus kinase (JAK) inhibitor, and it was first approved by the FDA on November 16, 2011, under the brand name Jakafi, which is manufactured by Incyte Corporation [1].
Apotex, a Canadian pharmaceutical company, received approval from the FDA for its Ruxolitinib tablets on June 25, 2021 [2]. According to DrugPatentWatch.com, Apotex's Ruxolitinib tablets are bioequivalent to Jakafi [3].
It's important to note that the FDA submission date for Apotex's Ruxolitinib is not publicly available. The approval date and bioequivalence information suggest that Apotex's Ruxolitinib went through the FDA's abbreviated new drug application (ANDA) process, which allows for the approval of generic versions of previously approved drugs [4]. However, the ANDA process does not require the submission date to be made public.
Sources:
1. U.S. Food and Drug Administration. (2011, November 16). FDA approves new drug to treat rare blood disorder. Retrieved from <
https://www.fda.gov/news-events/press-announcements/fda-approves-new-drug-treat-rare-blood-disorder>
2. U.S. Food and Drug Administration. (2021, June 25). FDA approves first generic of Jakafi to treat certain patients with myelofibrosis. Retrieved from <
https://www.fda.gov/news-events/press-announcements/fda-approves-first-generic-jakafi-treat-certain-patients-myelofibrosis>
3. DrugPatentWatch.com. (n.d.). Ruxolitinib (Jakafi) by Incyte Corporation. Retrieved from <
https://www.drugpatentwatch.com/drugs/ruxolitinib-jakafi-incyte-corporation>
4. U.S. Food and Drug Administration. (n.d.). Abbreviated new drug application (ANDA). Retrieved from <
https://www.fda.gov/drugs/development-approval-process-drugs/abbreviated-new-drug-application-anda>