Natco Pharma receives tentative approval for Olaparib Tablets from U.S. FDA

Natco Pharma has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for Olaparib tablets (100 mg and 150 mg). The product is bioequivalent to the reference listed drug Lynparza® tablets of AstraZeneca Pharmaceuticals for the indication in the approved labelling. Alembic Pharmaceuticals will distribute the product in the U.S. market.

U.S. Market Opportunity

The estimated sales for Olaparib tablets were approximately USD 1.4 billion in the U.S. for the 12 months ending March 2026, according to industry sales data. The Para IV litigation regarding the product is currently ongoing.

Product and Regulatory Details

The key details surrounding this development are outlined below:

Parameter:	Details
Regulatory Approval:	Tentative U.S. FDA Approval
Product:	Olaparib Tablets (100 mg, 150 mg)
Reference Listed Drug:	Lynparza® tablets (AstraZeneca Pharmaceuticals)
U.S. Distribution Partner:	Alembic Pharmaceuticals
Estimated U.S. Sales (12 months ending Mar'26):	~USD 1.4 billion

1 Day	5 Days	1 Month	6 Months	1 Year	5 Years
-3.12%	-4.16%	+5.38%	+10.97%	-8.25%	-14.70%

Natco Pharma has completed the acquisition of an additional 13.25% equity stake in Adcock Ingram Holdings Proprietary Limited for an aggregate consideration of around ZAR 1.81 billion, equivalent to approximately ₹1,060 crore. With this transaction, Natco Pharma's total shareholding in the South African pharmaceutical company has increased from 35.75% to 49%. The acquisition was executed through Natco Pharma South Africa Proprietary Limited, a wholly-owned subsidiary, following the satisfaction of customary closing conditions and regulatory requirements.

Transaction Details

The board had initially approved the strategic investment to acquire the additional stake in Adcock Ingram. The completion of this deal marks a significant milestone in Natco Pharma's African growth strategy, consolidating its position as a major shareholder. The company first acquired a 35.75% stake in Adcock Ingram during the latter's delisting process in 2025.

Parameter	Details
Additional Stake Acquired	13.25%
Stake Before Acquisition	35.75%
Stake After Acquisition	49%
Total Consideration	ZAR 1.81 billion (~₹1,060 crore)

Strategic Context

Adcock Ingram is a leading South African healthcare company established in 1891, ranked second in the local pharmaceutical market. It manufactures and distributes a wide range of Prescription, OTC, Consumer, and Hospital products. The company holds a 10% market share in the private sector and is the leader in the OTC pharmaceutical market in South Africa. Natco Pharma, established in 1981, focuses on oncology, cardiology, and neurology, exporting products to over 50 countries.