Natco Pharma marketing partner gets USFDA nod for Carfilzomib Vials ANDA

Based on the ANDA filing date NATCO believes that 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.

In the year 2019, the parties have 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 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.

As per industry sales data, KYPROLIS had generated annual sales of $696million during the twelve months ending December 2020 in the US. 10mg strength alone generated sales of $63million for the same period.

Read also: Natco Pharma marketing partner gets USFDA approval for Everolimus tablets