Alembic Pharmaceuticals Limited’s partner NATCO Pharma Limited has received a major regulatory boost after securing tentative approval from the US FDA for Olaparib Tablets, 100 mg and 150 mg.

 

The approval covers NATCO’s Abbreviated New Drug Application (ANDA) for Olaparib Tablets, which have been classified as therapeutically equivalent to AstraZeneca Pharmaceuticals LP’s reference listed drug (RLD), Lynparza Tablets, 100 mg and 150 mg, for the approved indication.

 

Under the partnership arrangement, Alembic Pharmaceuticals will distribute the product in the U.S. market, while NATCO Pharma will undertake manufacturing of Olaparib Tablets.

 

The product approval comes with significant commercial potential, with Olaparib Tablets, 100 mg and 150 mg, estimated to represent a U.S. market size of approximately $1.4 billion for the 12 months ending March 2026, according to IQVIA data.

 

The Para IV litigation remains ongoing, even as the companies advance toward potential commercialization opportunities in the U.S. market.

 

With this latest development, Alembic Pharmaceuticals has achieved a cumulative total of 244 ANDA approvals from the USFDA, including 224 final approvals and 20 tentative approvals.

 

The latest regulatory milestone strengthens Alembic’s growing U.S. generics portfolio and highlights the continued expansion of its strategic partnership with NATCO Pharma.