The approved abbreviated new drug application (ANDA) is therapeutically equivalent to the reference listed drug (RLD), Lynparza Tablets, marketed by AstraZeneca Pharmaceuticals, for the indications specified in the approved labelling.

Under the partnership arrangement, NATCO Pharma will manufacture the Olaparib tablets, while Alembic Pharmaceuticals will distribute the product in the United States.

Olaparib, marketed under the brand name Lynparza, is a targeted cancer therapy belonging to the class of PARP inhibitors. It is indicated for the treatment of certain types of ovarian, breast, pancreatic and prostate cancers by preventing cancer cells with specific genetic mutations, such as BRCA or HRR mutations, from repairing damaged DNA.

The company said the Paragraph IV (Para IV) patent litigation related to the product is ongoing. According to industry sales data, Olaparib tablets recorded estimated U.S. sales of approximately USD 1.4 billion for the 12 months ended March 2026.

NATCO Pharma, headquartered in Hyderabad, develops, manufactures and markets generic and branded pharmaceuticals, specialty pharmaceuticals, active pharmaceutical ingredients (APIs) and crop protection products.

The company reported a 34.11% year-on-year decline in consolidated net profit to Rs 267.9 crore in Q4 FY26, compared with Rs 406.6 crore in the corresponding quarter last year. Revenue from operations declined 39.46% YoY to Rs 739.1 crore during the quarter ended 31 March 2026.