Natco Pharma Limited has announced that its marketing partner, Breckenridge Pharmaceutical Inc., has received approval for its Abbreviated New Drug Application (ANDA) for Carfilzomib Vials ANDA (generic for Kyprolis), from the US Food and Drug Administration (USFDA).
The parties have received final approval for 10 mg and 60 mg strengths of the product and tentative approval for 30 mg strength of the product. Based on the ANDA filing date, Natco believes that it is eligible for 180 days of sole generic marketing exclusivity for the 10 mg strength and shared 180 days of generic marketing exclusivity for the 60 mg strength of the product at the time of launch, the company informed BSE in a regulatory filing.
In 2019, the parties reached a settlement agreement on para IV litigation related to the product with Onyx Therapeutics, Inc. By virtue of the settlement, Natco and Breckenridge have been granted a licence permitting the launch of their generic Carfilzomib products on a date that is held as confidential in 2027 or sooner depending on certain occurrences.
As per industry sales data, Kyprolis had generated annual sales of $696 million during the 12 months ended December 2020 in the US. The 10 mg strength alone generated sales of $63 million for the same period.