Natco Pharma on Monday said its marketing partner Breckenridge Pharmaceutical Inc has received approval from the US health regulator for anti-cancer drug Carfilzomib Vials.
'Breckenridge Pharmaceutical Inc. (BPI), 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),' Natco Pharma said in a regulatory filing.
Natco has tied up with Breckenridge Pharmaceutical Inc to market the product in the US.
'The parties have received final approval for 10 mg and 60 mg strengths of the product and tentative approval for the 30 mg strength of the product,' it added.
Natco Pharma said based on the ANDA filing date, the company 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.
In 2019, the parties reached a settlement agreement related to the product with Onyx Therapeutics, Inc.
'By virtue of the settlement, Natco and Breckenridge have been granted a license permitting the launch of their generic carfilzomib products on a date that is held as confidential in the year 2027 or sooner depending on certain occurrences,' the company said.
Quoting industry sales data, Natco Pharma said Kyprolis had generated annual sales of USD 696 million during the twelve months ending December 2020 in the US. 10mg strength alone generated sales of USD 63 million for the same period.
Kyprolis is used to treat multiple myeloma.
Natco Pharma is an Indian multinational pharmaceutical company based in Hyderabad. The company is engaged in developing, manufacturing and marketing of finished dosage formulations and active pharmaceutical ingredients.