While the 10mg and 60mg strengths, of the product, have received final approval from the regulator, the 30mg strength has got a tentative approval.
Natco Pharma on Monday said the U.S. Food and Drug Administration (USFDA) has approved marketing partner Breckenridge Pharmaceutical’s abbreviated new drug application (ANDA) for Carfilzomib Vials, a generic version of anti-cancer drug Kyprolis.
While the 10mg and 60mg strengths, of the product, have received final approval from the regulator, the 30mg strength has got a tentative approval. Natco believes it is eligible for 180 days of sole generic marketing exclusivity for the 10mg strength and shared 180 days of generic marketing exclusivity for the 60mg strength of the product at the time of launch, a release from the Hyderabad-based drugmaker said.
On the launch date, the release said Natco and Breckenridge had in 2019 reached a settlement agreement on a Para IV litigation related to the product with Onyx Therapeutics. By virtue of the settlement, they were granted a license permitting launch of their generic carfilzomib products. The launch will be on date, which is a confidential, in 2027 or sooner depending on certain occurrences.
Kyprolis had generated annual sales of $696 million during the 12 months ended December 2020 in the U.S. The 10mg strength alone generated sales of $63million for the same period, Natco said citing industry sales data.
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