Natco, Breckenridge obtain FDA nod for generic Kyprolis

Natco Pharma’s marketing partner, Breckenridge, has received the Food and Drug Administration’s blessing for carfilzomib vials.

The product is the generic of Amgen’s Kyprolis. It is used to treat adult patients with relapsed or refractory multiple myeloma who have received one to three previous treatments for multiple myeloma.

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. Based on the ANDA filing date, Natco said it 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 on para IV litigation related to the product with Onyx Therapeutics. 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.

Kyprolis had a market value of $696 million while the 10-mg strength had a market value of $63 million for the 12 months ended December 2020, according to industry sales data.