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Natco Pharma has received USFDA tentative approval for its ANDA for Olaparib Tablets

ICICIdirect Research 20 Jul 2026 DISCLAIMER

News: Natco Pharma has received USFDA tentative approval for its Abbreviated New Drug Application (ANDA) for Olaparib Tablets (100 mg and 150 mg), the generic version of AstraZeneca's Lynparza, indicated for approved oncology indications. Under the partnership, NATCO will manufacture the tablets while Alembic Pharmaceuticals will exclusively distribute the product in the US. Commercial launch remains subject to the resolution of the ongoing Paragraph IV patent litigation. According to IQVIA, Lynparza recorded annual US sales of approximately USD 1.4 billion for the 12 months ended March 2026. Following the approval, Alembic's cumulative USFDA ANDA approvals have reached 244, comprising 224 final approvals and 20 tentative approvals. 

View: Considering the market size, it is a promising opportunity for Natco. However, given that it is a tentative approval and the ongoing litigation (by AstraZeneca)is still live, we will wait for the final approval and the management commentary in this regard at the time of Q1 earnings.

Impact: Neutral

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