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Lupin and Zydus Life Shares Tumble After US Court Loss in Myrbetriq Patent Battle

Mumbai, April 16, 2025 – In a significant legal and financial blow, Indian pharmaceutical majors Lupin Ltd and Zydus Lifesciences Ltd (Zydus Life) have suffered a major defeat in a US Federal Court patent case concerning Myrbetriq, a drug used to treat overactive bladder.

The ruling, delivered by the Delaware District Court on April 15, favored Japanese pharma giant Astellas Pharma, which holds the US patent rights for Myrbetriq.


Market Reaction: Sharp Drop in Shares

As markets opened on April 16, Lupin shares fell by 4.5%, while Zydus Life dropped 3%, reflecting investor concerns over the potential financial implications of the ruling. Myrbetriq was expected to be a significant growth driver for both companies in the US generics market.

According to an Equirus Securities note, Myrbetriq could have contributed up to $30 million in quarterly revenues for each company — a forecast that now appears under serious threat.


Court Ruling: Generics’ Claims Rejected

In its verdict, the Delaware District Court ruled:

“The Generics Manufacturers did not prove their asserted invalidity defenses by clear and convincing evidence.”

The court concluded that both Lupin and Zydus, referred to as the “Generics Manufacturers” in the litigation, failed to invalidate Astellas’s patent claims. This paves the way for potential market withdrawal of their generic versions of Myrbetriq in the US and the prospect of monetary penalties.

The ruling further stated:

“Infringement, damages, and any additional invalidity theories will be litigated at the consolidated jury trial in 2026.”


Financial Implications: Earnings May Be Hit

Speaking to CNBC-TV18, Vishal Manchanda, Pharma Analyst at Systematix Group, warned that the ruling could dent the FY26 earnings of both companies.

“This verdict could lead to substantial penalties payable to Astellas. If Lupin and Zydus are forced to pull their generics, the revenue loss will be significant,” Manchanda said.

The US is a key market for both drugmakers, and Myrbetriq — a once-daily beta-3 adrenergic agonist — had emerged as a high-potential product for their generics portfolios.


Myrbetriq: A Lucrative Yet Contested Market

  • Brand name: Myrbetriq
  • Original developer: Astellas Pharma
  • Annual US sales (pre-generic entry): Approx. $1.3 billion
  • Therapeutic use: Treatment for overactive bladder (OAB)
  • Generic versions launched by: Lupin and Zydus Life

This case follows similar high-stakes legal battles in the US pharmaceutical market, where originator companies continue to defend lucrative drug patents fiercely against generic entrants.


What Happens Next?

  • Lupin and Zydus may have to withdraw their products from the US market in compliance with the order.
  • The consolidated jury trial scheduled for 2026 will determine the scale of infringement damages.
  • Both companies may explore legal appeals or settlements, though no public statements have yet been issued.

Legal experts suggest that market access suspension and litigation risk may impact ongoing product launches and R&D pipeline planning for both companies.


Investor Sentiment and Analyst Outlook

The ruling has prompted a flurry of analyst downgrades and stock target revisions:

  • Brokerage View: Some analysts have reduced their FY26 EPS forecasts for Lupin and Zydus by 5–7%.
  • Stock Volatility: Pharma sector watchers expect continued pressure on both stocks until clarity emerges post-trial.

The US court’s verdict in the Myrbetriq patent case marks a sharp legal setback for Lupin and Zydus Life, both of whom had hoped to capitalize on the drug’s massive market potential. With the risk of market exit, revenue loss, and legal damages, the companies now face a complex mix of legal, financial, and reputational challenges in one of their key export markets.

Hindustan Herald will continue to track developments from the upcoming litigation phases and corporate responses from the affected pharma firms.


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