Lupin shares gain ahead of US drug launch that can fetch $200 million in FY26

Share of Lupin Ltd. are trading with gains of about 3% on Wednesday, April 23, following news of a key product launch.

Lupin is set to launch gTolvaptan (the generic version of Jynarque) in the US today, as Otsuka’s exclusivity comes to an end.

The company will enjoy a 180-day sole generic exclusivity, potentially extending further, and is expected to remain the only generic player for most of FY26.

With this launch, Lupin’s FY26 revenue opportunity is estimated at $150–200 million. gTolvaptan could contribute over 25% to Lupin’s FY26 earnings, making it a key growth driver for the year.

The launch also helps offset revenue loss from gMirabegron sales during FY26.

Lupin had received tentative FDA approval for Tolvaptan tablets (gJynarque) in October 2023.

In light of these developments, brokerage firm Axis Capital had revised its FY26 EBITDA and PAT estimates by 8% and 10%, respectively.

Lupin, along with Zydus Lifesciences, faced a legal setback in the US. The two pharmaceutical companies lost a patent litigation case concerning Mirabegron, the generic equivalent of Myrbetriq, a drug used to treat overactive bladder.

The US Federal Court ruled in favour of Astellas Pharma, the original developer of Myrbetriq, upholding the validity of Patent 780.

Astellas had sued both Lupin and Zydus, alleging their generic versions infringed on its patent rights. The court’s decision followed a bench trial and marks a victory for Astellas.

The ruling was seen as a negative development for Lupin and Zydus, as it effectively blocks their ability to market the generic drug in the US. Analysts suggest the companies may also face financial penalties. Furthermore, they may now be required to withdraw existing stock from the market.

The stock of Lupin Ltd. is currently trading 1.89% higher at ₹2,085.30. On a year-to-date basis, its down 12%.