U.S. Federal Court blocks Lupin, Zydus Life from bringing generic Myrbetriq to market
A U.S. Federal Court has reportedly ruled in favor of Astellas Pharma in a patent litigation case over generic Myrbetriq, according to a livemint.com report.
The ruling blocks Lupin and Zydus Life from selling their generic version of Mirabegron, the bioequivalent of Astellas' overactive bladder drug, Myrbetriq, in the United States.
According to the judgment, the Delaware District Court upheld the validity of Astellas Pharma’s Patent 780 and dismissed the invalidity arguments presented by Lupin and Zydus. Astellas had sued both companies for allegedly infringing on its patent by planning to market generic versions of Myrbetriq. The court concluded that neither Lupin nor Zydus had sufficiently demonstrated the patent's invalidity due to lack of enablement, written description or indefiniteness, the report said.
[Read more: Lupin receives FDA OK for generic Banzel]
The court order added that infringement and damages will be addressed in a consolidated jury trial in 2026. Both Indian firms have filed a 'Motion to Clarify’ in an effort to bring additional validity arguments, but those too will be litigated only during the next phase, the report noted.
Lupin and Zydus were among the first to launch 25 mg versions of the drug in the United States and had plans to release the 50 mg dosage soon. Analysts noted that this outcome could potentially lead to financial penalties, recalls of existing stock and blocked access to a high-value product in the U.S. pharma market, the report added.
Lupin had launched its generic version after obtaining FDA approval, but the approval has now been effectively overridden by the U.S. court’s ruling in favor of Astellas’ patent enforcement. Myrbetriq, a prescription treatment for overactive bladder and neurogenic detrusor overactivity, is one of Astellas’ key products globally, the report said.
[Read more: Lupin launches generic Minzoya]