Lupin Share Gains 1% on US Launch of gTolvaptan With $200 Million FY26 Potential

Shares of Lupin Ltd. gained around 1% on Thursday, April 24, following the announcement of a major product launch in the US market. The pharmaceutical company is set to launch gTolvaptan, the generic version of Otsuka’s Jynarque, as the latter’s exclusivity ends.

Lupin will enjoy a 180-day sole generic exclusivity, which could potentially extend further, positioning it as the only generic player for the majority of FY26. This development presents a significant revenue opportunity, estimated between $150–200 million, with gTolvaptan expected to contribute over 25% to Lupin’s FY26 earnings.

The launch is also expected to partially offset losses from gMirabegron, a product affected by recent legal developments. Lupin had previously secured tentative approval from the US FDA for Tolvaptan tablets in October 2023.

Brokerage firm Axis Capital has revised Lupin’s FY26 EBITDA and PAT estimates upward by 8% and 10%, respectively, citing the earnings potential from this high-value launch.

Patent Blow for Lupin and Zydus in gMirabegron Case

In contrast to the gTolvaptan milestone, Lupin, along with Zydus Lifesciences, suffered a legal defeat in the US concerning gMirabegron, the generic equivalent of Astellas Pharma’s Myrbetriq—a treatment for overactive bladder.

A US Federal Court ruled in favor of Astellas, upholding the validity of Patent 780, which covers Myrbetriq. The verdict followed a bench trial and is considered a major setback for the Indian drugmakers. Astellas had previously sued both Lupin and Zydus for patent infringement.

The ruling now prevents Lupin and Zydus from selling their generic versions in the US market, and analysts warn of possible financial penalties and mandatory withdrawal of existing stock.

This mixed outcome underscores the dual nature of Lupin’s US business outlook—buoyed by exclusivity on one front, while constrained legally on another.

Stock Performance 

On April 24, Lupin share price traded 0.69% higher at ₹2,103.20 at 2:17 PM (IST). Lupin share price reached a 52-week high of ₹2,403.45, and a 52-week low of ₹1,493.75. At the current price, Lupin shares are trading at a price-to-earnings (P/E) ratio of 31.32x, based on its trailing 12-month earnings per share (EPS) of ₹67.15, and a price-to-book (P/B) ratio of 4.37, according to exchange data. 

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