Natco Pharma has received tentative approval from the United States Food and Drug Administration (USFDA) for Olaparib, 100 mg, and 150 mg, as bioequivalent to reference listed drug (RLD) Lynparza tablets of AstraZeneca Pharmaceuticals for the indication in the approved labelling. NATCO will be manufacturing Olaparib tablets and its partner Alembic Pharmaceuticals (Alembic), would be distributing the product in the U.S.
The Para IV litigation is on-going. Olaparib tablets had estimated sales of around $1.4 billion in the U.S. for 12 months ending March 2026 as per industry sales data.
Natco Pharma is a vertically integrated and R&D focused pharmaceutical company engaged in developing, manufacturing and marketing of Finished Dosage Formulations (FDF) and Active Pharmaceutical Ingredients (APIs).
