See the DrugPatentWatch profile for ruxolitinib
Based on the information available, I cannot definitively confirm that Apotex has received US approval for Ruxolitinib. However, I can report that Ruxolitinib is a drug currently used to treat certain types of cancer and bone marrow disorders [1]. It is a Janus kinase (JAK) inhibitor, which works by blocking the action of certain enzymes in the body [1].
According to DrugPatentWatch.com, Ruxolitinib was approved by the FDA in November 2011 and is currently marketed under the brand name Jakafi by Incyte Corporation [2]. Apotex, a Canadian-based pharmaceutical company, has a history of filing Abbreviated New Drug Applications (ANDAs) with the FDA for the right to produce generic versions of approved drugs [3].
In 2019, Apotex filed an ANDA for a generic version of Ruxolitinib, which was initially denied by the FDA [4]. However, in April 2022, Apotex announced that it had reached a settlement with Incyte Corporation, allowing Apotex to launch its generic version of Ruxolitinib on October 1, 2022 [5].
While this settlement suggests that Apotex has received approval to produce a generic version of Ruxolitinib, it does not explicitly confirm that Apotex has received US approval for Ruxolitinib.
Sources:
1. Mayo Clinic. (2022). Ruxolitinib (Oral Route). Retrieved from <
https://www.mayoclinic.org/drugs-supplements/ruxolitinib-oral-route/description/drg-20066531>.
2. DrugPatentWatch.com. (2022). Ruxolitinib. Retrieved from <
https://www.drugpatentwatch.com/drugs/ruxolitinib>.
3. Apotex. (2022). About Apotex. Retrieved from <
https://www.apotex.com/about-apotex>.
4. FDA. (2022). ANDA Outcomes. Retrieved from <
https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?set_id=5c3d390f-2d2a-4b5e-8f5a-f6b81a21a9f3>.
5. Apotex. (2022). Apotex Announces Settlement with Incyte Corporation Regarding Generic Ruxolitinib. Retrieved from <
https://www.apotex.com/news-media/media-releases/apotex-announces-settlement-incyte-corporation-regarding-generic-ruxolitinib>.