Mumbai, India July 20: Alembic Pharmaceuticals Limited (Alembic) today announced that its Partner NATCO Pharma Limited (NATCO) has received tentative approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Olaparib Tablets, 100 mg and 150 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Lynparza Tablets, 100 mg and 150 mg, of AstraZeneca Pharmaceuticals LP (AstraZeneca) for the indication in the approved labelling. Alembic will distribute the product in the U.S., and its partner NATCO will manufacture Olaparib Tablets, 100 mg and 150 mg.
The Para IV litigation is on-going. Olaparib Tablets, 100 mg and 150 mg, have an estimated market size of approximately USD 1.4 billion in the U.S. for twelve months ending March 2026, according to IQVIA.
Alembic has a cumulative total of 244 ANDA approvals (224 final approvals and 20 tentative approvals) from USFDA.
