Zydus follows Lupin with Myrbetriq settlement deal

Zydus Lifesciences has reached a settlement agreement with Astellas in a patent dispute involving overactive bladder therapy Myrbetriq, which will allow its generic to remain on sale in the US.

The Indian company and its US unit will pay $120 million to Astellas, as well as a fee for each unit of generic sold in the US until September 2027, when Astellas' claimed patent protection on Myrbetriq is set to expire, to resolve the legal dispute.

The deal comes just a couple of days after another generic manufacturer, Lupin, agreed to a similar settlement with Astellas with a value of around $90 million.

Zydus' announcement marks the end of a long-running dispute between the companies that dates back to 2024, when it launched a generic of Myrbetriq (mirabegron) in the US, shortly after Astellas' request for an injunction was denied in a US district court. In April 2025, the court said it would not strike Astellas' patents on Myrbetriq, setting up a jury trial that had been due to take place later this year.

In a statement, the Japanese group said that the two agreements "conclude all litigation between Astellas and the two companies relating to Myrbetriq and mirabegron."

It added that it will receive a total of $60 million to resolve the litigation from the two generic companies combined, plus upfront license payments totalling $150 million and "prepaid per-unit licensing fees for each unit sold" of their generics.

The remaining terms of the agreements are confidential, according to Astellas, which is currently reviewing the financial impact of the deals.

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.

After Lupin's settlement, 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.

Other companies that have FDA approval in hand for generic mirabegron products include Alkem Labs, Ascent Pharma, MSN Labs, Qilu Pharma, and Sawai.