NATCO Pharma Secures USFDA Tentative Approval for Alembic's Olaparib Tablets
Alembic Pharmaceuticals Limited has announced that its partner, NATCO Pharma Limited, has received tentative approval from the United States Food and Drug Administration (USFDA) for the Abbreviated New Drug Application (ANDA) related to Olaparib Tablets, 100 mg and 150 mg. The approval pertains to the ANDA, which is therapeutically equivalent to Lynparza Tablets, 100 mg and 150 mg, manufactured by AstraZeneca Pharmaceuticals LP for specific indications.Under this partnership structure, Alembic will handle the distribution of the product in the U.S., while its partner NATCO Pharma Limited will be responsible for manufacturing the Olaparib Tablets (100 mg and 150 mg).
The ANDA covers a therapeutic equivalent to the reference listed drug product. Market analysts estimate that the Olaparib Tablets, 100 mg and 150 mg, command an estimated market size of approximately USD 1.4 billion in the U.S. for twelve months ending March 2026, according to IQVIA. The company noted that Para IV litigation pertaining to the product is currently ongoing.
Alembic's Regulatory Portfolio and Scale
The achievement comes as part of a broader regulatory success story for Alembic Pharmaceuticals Limited. The company has accumulated a cumulative total of 244 ANDA approvals from USFDA, consisting of final approvals totaling 224 and tentative approvals accounting for 20.The market significance of the product can be summarized below:
| Parameter | Detail |
|---|---|
| Product Approved | Olaparib Tablets (100 mg and 150 mg) |
| Approval Status | USFDA Tentative Approval (ANDA) |
| Therapeutic Equivalence | Lynparza Tablets (AstraZeneca) |
| Market Size Estimate | Approximately USD 1.4 billion in the U.S. (for 12 months ending March 2026, per IQVIA) |
| Alembic's Total ANDA Approvals | 244 (224 Final, 20 Tentative) |
About Alembic Pharmaceuticals Limited
Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company with a history spanning since 1907. Headquartered in India, the publicly listed company manufactures and markets generic pharmaceutical products globally.Alembic's facilities are state of the art and have been approved by regulatory authorities across many developed countries, including the USFDA. Recognized as one of the leaders in branded generics in India, Alembic’s brands reach doctors and patients through a field force exceeding 5500 members.
APLLTD Stock Price Movement
Shares of Alembic Pharmaceuticals Limited slipped on Friday, closing at ₹825.10 after shedding ₹11.85, which accounted for a 1.41% decline. The stock traded heavily during the session and touched a day low of ₹821.Disclaimer: Due care and diligence have been taken in compiling and presenting news and market-related content. However, errors or omissions may arise despite such efforts.
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