Lupin Limited has reached a USD 90 million settlement to resolve a patent dispute with Japan-based Astellas Pharma concerning Lupin’s generic version of mirabegron, a treatment for overactive bladder. The agreement concludes ongoing litigation in the United States and provides commercial clarity around Lupin’s continued participation in the market.
Under the settlement and licensing arrangement, Lupin and its US subsidiary will make structured payments totaling USD 90 million to Astellas. This includes a substantial upfront component along with licensing-related payments tied to product sales through an agreed period. While specific commercial details remain confidential, the settlement removes legal uncertainty surrounding the product.
The dispute originated after Lupin obtained US regulatory approval for its generic mirabegron, which Astellas challenged through patent litigation. A prior court ruling had upheld Astellas’ patent claims, creating uncertainty over Lupin’s market position. By settling, Lupin avoids prolonged legal proceedings and secures a defined commercial pathway for the product.
Industry observers view the resolution as a strategic move that stabilizes Lupin’s US portfolio and reduces litigation risk. The agreement is expected to support continuity of supply and revenue visibility in a competitive therapeutic segment.
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