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Lupin Limited on Tuesday, February 10, said it has entered into a settlement and licence agreement with Astellas Pharma to resolve a long-running patent infringement dispute related to the bladder control drug Mirabegron, removing a key overhang on the product in the US market.
In an exchange filing, Lupin said the company and its wholly owned US subsidiary, Lupin Pharmaceuticals Inc., will pay Astellas a total of $90 million, which includes a $75 million prepaid option payment, along with an undisclosed per-unit licence fee on each unit of Mirabegron sold from the date of settlement through September 2027.
The detailed terms of the settlement remain confidential, the company said.
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The agreement brings an end to Lupin’s pending litigation with Astellas, disclosed earlier in April 2025, and allows the company to continue selling Mirabegron in the US.
According to analysts, Mirabegron is an important product for Lupin, contributing over $100 million annually to its US revenues. The settlement, while negative for near-term profitability due to the upfront payment and ongoing licence fees, significantly improves revenue visibility for the product through mid-FY28, they said.
Analysts added that the deal eliminates intellectual property risk around Mirabegron, which had been a key concern for investors. However, they cautioned that margins on the product are likely to remain under pressure over the settlement period.
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The development is also being closely watched across the sector, as Zydus Lifesciences, which also sells Mirabegron in the US, derives up to $300 million annually from the drug, making any legal or regulatory developments around the molecule significant for peers.
Shares of Lupin ended 2,208.70
In an exchange filing, Lupin said the company and its wholly owned US subsidiary, Lupin Pharmaceuticals Inc., will pay Astellas a total of $90 million, which includes a $75 million prepaid option payment, along with an undisclosed per-unit licence fee on each unit of Mirabegron sold from the date of settlement through September 2027.
The detailed terms of the settlement remain confidential, the company said.
Read more: Amber Enterprises shares jump 3% as Q3 revenue, EBITDA beat estimates; PAT turns loss
The agreement brings an end to Lupin’s pending litigation with Astellas, disclosed earlier in April 2025, and allows the company to continue selling Mirabegron in the US.
According to analysts, Mirabegron is an important product for Lupin, contributing over $100 million annually to its US revenues. The settlement, while negative for near-term profitability due to the upfront payment and ongoing licence fees, significantly improves revenue visibility for the product through mid-FY28, they said.
Analysts added that the deal eliminates intellectual property risk around Mirabegron, which had been a key concern for investors. However, they cautioned that margins on the product are likely to remain under pressure over the settlement period.
Read more: Axis Bank buying CreditAccess Grameen will be a 'win-win', CLSA says
The development is also being closely watched across the sector, as Zydus Lifesciences, which also sells Mirabegron in the US, derives up to $300 million annually from the drug, making any legal or regulatory developments around the molecule significant for peers.
Shares of Lupin ended 2,208.70
