Lupin clears Mirabegron patent dispute with Astellas in $90 million deal, secures US sales continuity

Drugmaker Lupin has reached a settlement with Astellas Pharma and its affiliates to resolve an ongoing patent infringement dispute related to its Mirabegron product, agreeing to pay a total of $90 million as part of the deal.

In a regulatory filing on Tuesday, the company said it and its wholly owned subsidiary, Lupin Pharmaceuticals, Inc., USA, “have entered into a Settlement and License Agreement” with Astellas Pharma, Inc., Astellas Ireland Co., Ltd., and Astellas Pharma Global Development, Inc.

Under the agreement, Lupin will pay Astellas $90 million, which includes a prepaid option payment of $75 million, along with a prepaid per-unit licence fee for each unit of the Lupin product sold from the date of settlement through September 2027.

The financial and commercial terms of the settlement remain confidential.

The company said the agreement resolves its pending litigation with Astellas and enables it to continue marketing and selling Mirabegron in the United States, removing a key legal overhang tied to the product.

Lupin had earlier disclosed the patent dispute in April 2025. The latest settlement brings closure to the matter and provides visibility on the drug’s near-term commercial trajectory.