NATCO Secures USFDA Tentative Approval for Generic Olaparib Tablets, $1.4 bn Market Target

Alembic Pharmaceuticals announced that its partner NATCO Pharma has received tentative approval from the US Food and Drug Administration for an abbreviated new drug application covering 100 mg and 150 mg generic Olaparib tablets, a PARP inhibitor used in cancer therapy. The approval applies to the same indication as AstraZeneca’s branded Lynparza and positions the product to address an estimated $1.4 billion US market for the 12 months ending March 2026. Alembic will handle US distribution while NATCO will manufacture the tablets, adding to Alembic’s total of 244 FDA ANDA approvals. The commercial launch, however, remains uncertain pending the outcome of ongoing Paragraph IV patent litigation. The milestone underscores the growing presence of Indian generic manufacturers in the US market.