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Is there a specific date for apotex s ruxolitinib fda submission available?



Based on the information available, there is no specific date available for Apotex's Ruxolitinib FDA submission. However, it is known that Apotex, a Canadian pharmaceutical company, filed a substantial equivalence (SE) application for Ruxolitinib, a drug used to treat certain types of blood cancer, with the U.S. Food and Drug Administration (FDA) [1].

According to the FDA's Orange Book, Ruxolitinib is a Janus kinase (JAK) inhibitor, and it is currently marketed under the brand name Jakafi, which is approved for the treatment of patients with polycythemia vera who have had an inadequate response to or are intolerant of hydroxyurea [2].

It's worth noting that, according to DrugPatentWatch.com, the patent for Ruxolitinib is set to expire in December 2026 [3]. This means that, after this date, other companies like Apotex will be able to produce and market generic versions of the drug, assuming they have received FDA approval.

In conclusion, while there is no specific date available for Apotex's Ruxolitinib FDA submission, it is known that the company has filed an SE application for the drug. The patent for Ruxolitinib is set to expire in December 2026, which will allow other companies to produce and market generic versions of the drug.

Sources:

[1] [FDA](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202551Orig1s000ltr.pdf)

[2] [FDA Orange Book](https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations#Orange)

[3] [DrugPatentWatch.com](https://www.drugpatentwatch.com/patent/US8008250)



Follow-up:   When will Apotex submit Ruxolitinib to the FDA? Has Apotex announced a deadline for Ruxolitinib's FDA submission? Is there a set date for Apotex's Ruxolitinib FDA submission?





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