Synopsis

Natco Pharma shares rose sharply on Monday after the U.S. FDA granted tentative approval for its generic Olaparib tablets, a bioequivalent version of AstraZeneca’s Lynparza. The drug addresses a $1.4-billion U.S. market opportunity. The company will manufacture the product, while Alembic Pharmaceuticals will handle its U.S. commercialisation.

Natco Pharma shares climbed as much as 4.5% on Monday, touching an intraday high of Rs 987.55 on the NSE, after the company announced that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its generic version of Olaparib Tablets.

The pharmaceutical company informed exchanges that the U.S. FDA has granted tentative approval for Olaparib Tablets in 100 mg and 150 mg strengths, which are bioequivalent to AstraZeneca's drug Lynparza. The approval covers the indications specified in the reference-listed drug's approved labelling.

Natco Pharma will manufacture the Olaparib tablets, while its marketing partner Alembic Pharmaceuticals Ltd. will commercialise and distribute the product in the U.S. market. The company also noted that the Para IV patent litigation remains ongoing.

According to industry sales data, Olaparib tablets generated estimated U.S. sales of approximately $1.4 billion for the 12 months ended March 2026, highlighting the significant market opportunity once the product receives final approval and litigation hurdles are resolved.

Recent corporate development

On July 14, the company completed the acquisition of an additional 13.25% stake in Adcock Ingram Holdings Proprietary Limited, one of South Africa's leading pharmaceutical and healthcare companies.

The transaction, executed through its wholly-owned subsidiary Natco Pharma South Africa Proprietary Limited, increased Natco's stake in Adcock Ingram from 35.75% to 49%. The acquisition was completed for an aggregate consideration of around ZAR 1.81 billion (approximately Rs 1,060 crore).

Stock Performance

The company currently commands a market capitalisation of approximately Rs 16,925 crore.

Valuation Snapshot

In terms of moving averages, the stock is trading below four of its eight key simple moving averages (SMAs) but continues to remain above its long-term 150-day and 200-day SMAs, reflecting resilience in the broader trend despite near-term weakness.

Shareholding Trend

(Disclaimer: Recommendations, suggestions, views and opinions given by the experts are their own. These do not represent the views of The Economic Times)

...moreless

...moreless