Natco Pharma has announced that its marketing partner, Breckenridge Pharmaceutical Inc. (BPI), has received final approval for its Abbreviated New Drug Application (ANDA) for Everolimus Tablets (generic for Afinitor) from the U.S. Food and Drug Administration (USFDA).

NATCO's partner BPI plans to launch 2.5 mg, 5 mg and 7.5 mg strengths of the product shortly within the next few weeks. The launch of 10mg strength of the product is subject to confidential terms of a settlement and license agreement entered into with the owner of the Afinitor® brand. The launch date of 10mg strength of the product will be announced at a later date.

As per industry sales data, Afinitor and its therapeutic equivalents had generated annual sales of $712 million in USA during the twelve months ending December 2020.