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How long has Apotex been selling ruxolitinib in the US? Apotex launched its ruxolitinib generic in the US on December 1, 2023, making it the first company to offer a lower-cost version of the drug. Why did Apotex receive first generic approval? Apotex gained the first generic approval for ruxolitinib because it was the first to submit a substantially complete Abbreviated New Drug Application (ANDA) with a Paragraph IV certification against the originator's patents. Paragraph IV certification asserts that the originator's patents are invalid or not infringed by the proposed generic. Why has Apotex been able to sell ruxolitis for more than a year? Apotex has been able to sell ruxolitinib for more than a year because the company secured first generic approval in December 2023 and no other generics have launched yet.
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