Natco Pharma gets FDA approval for Carfilzomib Vials ANDA
Natco Pharma Limited said that its marketing partner – Breckenridge Pharmaceutical Inc. (BPI), has secured approval from the US Food and Drug Administration (FSA) for its abbreviated new drug application (ANDA) for Carfilzomib Vials ANDA (generic for KYPROLIS).
Developed by Onyx Pharmaceuticals, KYPROLIS (carfilzomib) is indicated in the US for the treatment of multiple myeloma in adults whose condition is relapsed or refractory and who have been subject to one to three previous treatments for their disease. KYPROLIS is approved to be used in combination with daratumumab plus dexamethasone, dexamethasone or with lenalidomide plus dexamethasone.
Onyx Pharmaceuticals is currently owned by Amgen.
Natco Pharma along with Breckenridge Pharmaceutical has been given final approval for 10mg and 60mg strengths of the Carfilzomib Vials ANDA and tentative approval for its 30mg strength.
The Indian pharma company said that based on the filing date of ANDA, 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.
Natco Pharma gets FDA approval for Carfilzomib Vials ANDA. Photo courtesy of Colin Behrens from Pixabay.
In 2019, Natco Pharma and Breckenridge Pharmaceutical had reached a settlement agreement on para IV litigation pertaining to Carfilzomib Vials ANDA with Onyx Therapeutics.
Due to the settlement, NATCO Pharma and its marketing partner have been issued a license allowing the launch of their generic carfilzomib products on a date that is held as confidential in 2027 or earlier based on certain occurrences.
KYPROLIS had registered annual sales of $696 million in 2020 in the US, as per industry sales data. Of this, the 10mg strength itself contributed sales of $63 million.
Last month, Natco Pharma had received the final approval from the FDA of its ANDA for multiple myeloma and myelodysplastic syndromes treatment – Lenalidomide Capsules, 5mg, 1 Omg, 15mg, and 25mg, and the tentative approval of the 2.5mg and 20mg.