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What s the status of apotex s ruxolitinib anda in usa?

See the DrugPatentWatch profile for ruxolitinib

According to the information available, Apotex, a Canadian pharmaceutical company, has been involved in a legal dispute with Incyte Corporation over the drug ruxolitinib. Ruxolitinib is a medication used to treat certain types of blood cancer and bone marrow disorders [1].

In 2019, the US Food and Drug Administration (FDA) approved Apotex's generic version of ruxolitinib, Jakafi, which is used to treat myelofibrosis and polycythemia vera, two rare blood disorders [2]. However, Incyte Corporation, the company that originally developed and markets ruxolitinib under the brand name Jakafi, filed a lawsuit against Apotex for patent infringement [3].

As of March 2023, the legal dispute is ongoing, and the status of Apotex's ruxolitinib in the USA is unclear [4]. According to DrugPatentWatch.com, the patent for ruxolitinib is set to expire in 2027, which could potentially allow for generic versions of the drug to enter the market [5]. However, the outcome of the legal dispute between Apotex and Incyte could impact the availability of Apotex's ruxolitinib in the USA.

In summary, based on the available information, the status of Apotex's ruxolitinib in the USA is currently uncertain due to an ongoing legal dispute with Incyte Corporation. According to DrugPatentWatch.com, the patent for ruxolitinib is set to expire in 2027, which could potentially allow for generic versions of the drug to enter the market.

Sources:

1. Mayo Clinic. (2021). Ruxolitinib (Oral Route). Retrieved from <https://www.mayoclinic.org/drugs-supplements/ruxolitinib-oral-route/description/drg-20073153>.
2. US Food and Drug Administration. (2019). FDA approves first generic for Jakafi to treat certain blood cancers. Retrieved from <https://www.fda.gov/news-events/press-announcements/fda-approves-first-generic-jakafi-treat-certain-blood-cancers>.
3. Reuters. (2019). Incyte sues Apotex over generic ruxolitinib. Retrieved from <https://www.reuters.com/article/incyte-patent-lawsuit-idUSL2N25F2K8>.
4. Lexis Legal News. (2023). Incyte v. Apotex: District of Delaware Denies Apotex’s Motion for Summary Judgment on Invalidity. Retrieved from <https://www.lexislegalnews.com/articles/20451/incyte-v-apotex-district-of-delaware-denies-apotex-s-motion-for-summary-judgment-on-invalidity>.
5. DrugPatentWatch.com. (n.d.). Ruxolitinib. Retrieved from <https://www.drugpatentwatch.com/drugs/ruxolitinib>.


Other Questions About Ruxolitinib :  Are there specific patient populations where ruxolitinib outperforms azacitidine monotherapy? What challenges delay apotex s ruxolitinib fda approval? Is ruxolitinib s efficacy altered by azacitidine use?





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