Lupin settles Myrbetriq patent spat with Astellas for $90m

Lupin will be able to keep its generic of Astellas' overactive bladder therapy Myrbetriq on the US market, after reaching a settlement agreement.

In a statement, Japan's Astellas said the specific terms of the settlement were confidential; however, a regulatory filing has revealed that the Indian pharma group has agreed to pay $90 million to Astellas to settle pending patent litigation over Myrbetriq (mirabegron) in the US.

The deal includes an option payment of $75 million, along with a license fee for each unit of generic sold in the US until September 2027, when Astellas' claimed patent protection on Myrbetriq is set to expire.

Lupin launched its generic in 2024, after a district court in Delaware ruled that it and another Indian manufacturer, Zydus Lifesciences, denied Astellas' request to impose an injunction on the generics while patent litigation played out. In the following year, another court ruling raised the risk that the generics could be withdrawn from sale.

Myrbetriq – sold as Betanis and Betmiga in some markets – is an extended-release selective beta3-adrenoceptor agonist therapy used to treat overactive bladder with symptoms of urinary incontinence, urgency, and urinary frequency, and has been approved in the US since 2012.

Since that time, it has grown into one of Astellas' top-selling drugs, bringing in worldwide revenues of JPY 132.5 billion ($853 million), a rise of 6%, in the first nine months of its current financial year, which ends on 31st March.

Last week, the Japanese group raised its revenue and profit forecasts for the fiscal year, attributing the increase to the strong growth of Myrbetriq as well as prostate cancer therapy Xtandi (enzalutamide), which is also approaching the end of its patent-protected life.

In its statement on the Lupin settlement, Astellas said it is "reviewing potential financial impacts of this matter for the fiscal year."

Lupin said the agreement resolves the litigation and will allow it to continue to sell generic mirabegron without any further uncertainty. Analysts at Citi, reported by Reuters, said the settlement could also delay the entry of other generics, extending the period in which Lupin and Zydus can sell mirabegron with limited competition.