Lupin Limited Settlement Reached in Mirabegron Patent Infringement Dispute with Astellas

Lupin has announced the resolution of its patent infringement dispute concerning its product ‘Mirabegron’ against Astellas Pharma and its affiliates. The company entered into a Settlement and License Agreement, which includes a non-refundable initial payment of USD 75 million and a further USD 90 million aggregate payment. This settlement allows Lupin to continue selling its Mirabegron product through September 2027.

Resolution of Astellas Litigation

Lupin Limited has confirmed entering into a definitive Settlement and License Agreement (‘Agreement’) with Astellas Pharma, Inc., Astellas Ireland Co., Ltd., and Astellas Pharma Global Development, Inc. (collectively referred to as ‘Astellas’). This action settles the pending patent infringement dispute related to Lupin’s product, ‘Mirabegron’. The initial disclosure regarding this dispute was made on April 16, 2025.

Financial Terms of the Settlement

Under the terms outlined in the Agreement, Lupin is obligated to make specified payments to Astellas. These include a Prepaid Option Payment of USD 75 million. Furthermore, Lupin will pay a total of USD 90 million, which encompasses the initial option payment. An additional component involves a Prepaid Per Unit License Fee for every unit of Lupin Product sold from the date of the settlement until September 2027. The specific details regarding the overall settlement structure are confidential.

Business Continuity

This successful settlement eliminates the ongoing litigation risk associated with Astellas. Crucially, the Agreement grants Lupin the necessary licensing rights, allowing the company to continue the sale of its Mirabegron product in the market.

Source: BSE

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