Product Approval Announcement
Alembic Pharmaceuticals Limited announced that its partner NATCO Pharma Limited has received tentative approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Olaparib Tablets, 100 mg and 150 mg.
Product Details and Equivalence
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Lynparza Tablets, 100 mg and 150 mg, of AstraZeneca Pharmaceuticals LP for the indication in the approved labelling.
Manufacturing and Distribution Arrangement
Alembic Pharmaceuticals Limited will distribute the product in the U.S. market, while its partner NATCO Pharma Limited will manufacture Olaparib Tablets, 100 mg and 150 mg.
Legal Status and Market Context
The Para IV litigation for Olaparib Tablets is ongoing. According to IQVIA data, Olaparib Tablets, 100 mg and 150 mg, have an estimated market size of approximately USD 1.4 billion in the U.S. for the twelve months ending March 2026.
Cumulative Approvals
Alembic Pharmaceuticals Limited has a cumulative total of 244 ANDA approvals from USFDA, consisting of 224 final approvals and 20 tentative approvals.
Company Background
Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company that has been operating since 1907. The company manufactures and markets generic pharmaceutical products worldwide and is one of the leaders in branded generics in India with a field force of over 5500 representatives.