Alembic Pharmaceuticals Limited announced that its development partner, NATCO Pharma Limited (NATCO), has received tentative approval from the U.S. Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Olaparib Tablets, 100 mg and 150 mg.
The approved ANDA is therapeutically equivalent to AstraZeneca’s reference listed drug (RLD), Lynparza® Tablets. Under the strategic alliance, NATCO will handle the manufacturing of the tablets, while Alembic will spearhead commercial distribution within the United States market. The corresponding Para IV litigation for the generic drug is currently ongoing.
Olaparib is a high-value oncology therapeutic, commanding an estimated U.S. market size of approximately USD 1.4 billion for the twelve months ending March 2026, according to IQVIA data. This milestone further strengthens Alembic’s presence in the U.S. healthcare sector, bringing its cumulative regulatory pipeline to 244 USFDA ANDA approvals, consisting of 224 final approvals and 20 tentative approvals.
Operating since 1907, vertically integrated generic drug manufacturer Alembic continues to expand its global footprint through state-of-the-art research facilities.
Written by: Pragna Biswas
Graphics by: Pramit Hazra
