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See the DrugPatentWatch profile for ruxolitinib
Apotex's ruxolitinib FDA approval date Apotex filed an abbreviated new drug application (ANDA) for ruxolitinib tablets in strengths of 5 mg, 10 mg, 15 mg, and 20 mg. The FDA approved this generic version of Jakafi on 17 February 2025. What other approvals or challenges has Apotex's ruxolitinib faced? Apotex's generic ruxolitinib has been subject to patent litigation. Companies holding patents on the original branded version have challenged the entry of this and other generics. How does Apotex's ruxolitinib compete with other generics? Apotex is one of several companies pursuing generic versions of ruxolitinib. Other manufacturers have also filed ANDAs and received approvals, which may affect market exclusivity periods for early entrants. When does the ruxolitinib patent expire? The patents covering ruxolitinib and its use in myelofibrosis and polycythemia vera are scheduled to expire in 2030.
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