Natco Pharma announces submission of ANDA with USFDA for generic version of Olaparib Tablets
Olaparib is indicated primarily for certain forms of ovarian, breast, pancreatic and prostrate cancer.
Hyderabad: NATCO Pharma Limited has announced submission of Abbreviated New Drug Application (ANDA) containing a paragraph IV certification with the U.S. Food and Drug Administration (USFDA) for the generic version of Olaparib Tablets 100mg and 150mg.
Olaparib is indicated primarily for certain forms of ovarian, breast, pancreatic and prostrate cancer.
Olaparib Tablets are marketed in the United States (US) by AstraZeneca under brand Lynparza. NATCO has been named as defendant in a lawsuit filed in the US district court of New Jersey by AstraZeneca and Kudos Pharmaceuticals.
"NATCO and its co-development and marketing partner Alembic Pharmaceuticals believe that the ANDA is possibly sole first-to-file based on its filing date and may be eligible for 180 days of marketing exclusivity at the time of launch of the product," the release stated.
Lynparza has recorded sales of USD 1,226 million in the US market for the year ending December 2022, as per AstraZeneca results presentation.
Read also: DCGI nod to AstraZeneca India breast cancer drug Lynparza
Natco Pharma Limited was incorporated in Hyderabad in the year 1981 with an initial investment of INR 3.3 million. Natco has eight manufacturing facilities spread across India with modern research laboratories, capabilities in New Drug Development, etc.
It 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”). Its focus is primarily on niche therapeutic areas and complex products. Natco markets and distributes products in over 40 countries. The company sells its FDF products in the United States, India, Europe, and the rest of the world (“RoW”).
Natco Pharma manufactures API products which are primarily used for captive consumption in the company's FDF products and are also sold to customers for various international markets such as Brazil, Europe and USA. In the API segment, the company has capabilities to develop and manufacture products with multi-step synthesis, semi synthetic fusion technologies, high-potency APIs and peptides.
