Natco Pharma Ltd. shares rose 1.5% in early trade on Monday after the company received tentative approval from the US Food and Drug Administration (FDA) for its generic version of Olaparib tablets, used in the treatment of certain cancers.
The stock was trading at Rs 959.05 apiece on the National Stock Exchange around 9.50 am today, gaining 14 points from its previous close at Rs 945.
USFDA Tentative Approval
Natco Pharma said it has received tentative approval from the USFDA for Olaparib Tablets in 100 mg and 150 mg strengths, which are bioequivalent to AstraZeneca's reference drug Lynparza for approved indications. The company will manufacture the product, while its marketing partner, Alembic Pharmaceuticals Ltd., will distribute it in the US market.
In an exchange filing dated 18 July, the company stated, “NATCO Pharma Limited today received tentative approval from the U.S. FDA for Olaparib, 100 mg, and 150 mg, as bioequivalent to reference listed drug (RLD) Lynparza® tablets of AstraZeneca Pharmaceuticals for the indication in the approved labelling. NATCO will be manufacturing Olaparib tablets and our partner Alembic Pharmaceuticals Limited (Alembic), would be distributing the product in the U.S.
Investors will closely watch the progress of the ongoing patent litigation, as it will determine when Natco can launch the drug in the US. They will also monitor the company's next steps toward final FDA approval and commercialization with its partner, while assessing the potential impact on Natco's oncology business.
Large Market Opportunity
The company also stated that the Olaparib tablets' estimated sales in the US market stood around $1.4 billion during the 12 months ended March 2026, based on industry sales data. However, Natco noted that the Paragraph IV patent litigation remains ongoing, indicating that commercial launch timelines will depend on the legal outcome.
“The Para IV litigation is on-going. Olaparib tablets had estimated sales of approximately USD 1.4 billion in the U.S. for 12 months ending Mar'26 as per industry sales data,” the company said.
The tentative approval adds another specialty oncology product to Natco's US pipeline, a key growth segment for the company, which focuses on limited-competition generic medicines. Natco currently operates nine manufacturing facilities and two R&D centres in India, with products supplied to more than 50 global markets.
Shares Up Near 8% In 2026
The stock gained close to 8% in 2026, when the broader market index Nifty 500 was down 2.6%
Having said that, the stock was down for a week, losing a little over 2%, despite today's gains.
Currently, the stock is trading at a price-to-earnings multiple of 12.34 times, and had a market cap of Rs 17,178.4 crore as at the end of the previous session.
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