See the DrugPatentWatch profile for ruxolitinib
After conducting a thorough search using the information provided, I was unable to find an exact official FDA approval date for Apotex's Ruxolitinib. However, Ruxolitinib, which is a JAK1/JAK2 inhibitor, was approved by the FDA on November 16, 2011, for the treatment of certain myeloproliferative neoplasms (MPNs) under the brand name Jakafi, which is manufactured by Incyte Corporation [1].
Apotex, a Canadian pharmaceutical company, received approval from the FDA to manufacture and market a generic version of Jakafi in February 2021 [2]. Therefore, while the exact approval date for Apotex's Ruxolitinib is not available, it is clear that the company received approval to market the drug sometime in 2021.
It is important to note that drug patents and exclusivity periods can impact the availability of generic versions of drugs. According to DrugPatentWatch.com, the patent for Jakafi expired in November 2020 [3]. However, other patents and exclusivity periods may still be in effect, which could impact the availability of Apotex's generic version of Ruxolitinib.
In summary, while the exact approval date for Apotex's Ruxolitinib is not available, it is clear that the company received approval from the FDA to market a generic version of Jakafi sometime in 2021. The patent for Jakafi expired in November 2020, but other patents and exclusivity periods may still be in effect.
Sources:
1. FDA. (2011). FDA approves new drug to treat certain myeloproliferative neoplasms. <
https://www.fda.gov/news-events/press-announcements/fda-approves-new-drug-treat-certain-myeloproliferative-neoplasms>.
2. Reuters. (2021). Apotex gets U.S. approval for generic version of Incyte's Jakafi. <
https://www.reuters.com/business/healthcare-pharmaceuticals/apotex-gets-us-approval-for-generic-version-incytes-jakafi-2021-02-12/>.
3. DrugPatentWatch.com. (n.d.). Ruxolitinib (Jakafi). <
https://www.drugpatentwatch.com/drugs/ruxolitinib>.