See the DrugPatentWatch profile for ruxolitinib
Based on the information available, it can be confirmed that Apotex, a well-known pharmaceutical company, has submitted a generic version of Ruxolitinib to the U.S. Food and Drug Administration (FDA) [1]. Ruxolitinib is a medication used to treat certain types of blood cancer and bone marrow disorders [2].
Apotex's submission to the FDA is a significant development, as it could potentially lead to a more affordable version of Ruxolitinib becoming available in the market. The drug is currently marketed under the brand name Jakafi by Incyte Corporation [1].
According to DrugPatentWatch.com, the patent for Ruxolitinib is set to expire in 2027, but there are no exclusivity restrictions in place [3]. This means that once the patent expires, other companies like Apotex can manufacture and sell generic versions of the drug [3]. However, Apotex's submission to the FDA indicates that they are looking to enter the market before the patent expires.
It's worth noting that the FDA approval process for generic drugs can be lengthy and complex [4]. Therefore, even though Apotex has submitted its generic version of Ruxolitinib to the FDA, it may still be some time before it becomes available to patients.
In summary, Apotex has submitted a generic version of Ruxolitinib to the FDA, which could potentially lead to a more affordable version of the drug becoming available in the market. However, the FDA approval process can be lengthy and complex, so it may still be some time before the generic version becomes available.
Sources:
[1] "Apotex Submits Generic Version of Jakafi(R) (Ruxolitinib) Tablets to the FDA." Apotex, 26 Jan. 2022, www.apotex.com/news/press-releases/apotex-submits-generic-version-jakafi-ruxolitinib-tablets-fda.
[2] "Ruxolitinib." Mayo Clinic, Mayo Foundation for Medical Education and Research, 21 Jan. 2022, www.mayoclinic.org/drugs-supplements/ruxolitinib-oral-route/description/drg-20066522.
[3] "Ruxolitinib." DrugPatentWatch, drugpatentwatch.com/drugs/ruxolitinib.
[4] "Generic Drug Development and Approval." U.S. Food and Drug Administration, FDA, www.fda.gov/drugs/development-approval-process-drugs/generic-drug-development-and-approval.