See the DrugPatentWatch profile for ruxolitinib
Based on the information available, there are indications that Apotex, a well-known pharmaceutical company, has submitted an Abbreviated New Drug Application (ANDA) for a generic version of Ruxolitinib to the U.S. Food and Drug Administration (FDA) [1]. However, as of the time of this response, there has been no official public announcement from the FDA confirming the completion of the review process and the approval of Apotex's ANDA for Ruxolitinib [2].
It is important to note that the drug patent for Ruxolitinib, which is currently marketed under the brand name Jakafi by Incyte Corporation, is set to expire in 2027 [3]. This means that any generic version of the drug can only be approved and enter the market after this date.
In summary, while there are signs that Apotex has submitted an ANDA for a generic version of Ruxolitinib to the FDA, there has been no official confirmation of the completion of the review process and approval of the application. Additionally, it is worth noting that the patent for Ruxolitinib does not expire until 2027.
Sources:
1. [DrugPatentWatch.com](
https://www.drugpatentwatch.com/drugs/ruxolitinib)
2. 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>
3. Incyte Corporation. (n.d.). Jakafi (ruxolitinib) tablets. Retrieved from <
https://www.jakafi.com/>