The US Federal Court ruled in favour of Astellas Pharma, the original developer of Myrbetriq, upholding the validity of Patent 780.
Astellas had sued both Lupin and Zydus, alleging their generic versions infringed on its patent rights. The court’s decision followed a bench trial and marks a significant victory for Astellas.
The ruling would be viewed as a negative development for Lupin and Zydus, as it effectively blocks their ability to market the generic drug in the US. Analysts suggest the companies may also face financial penalties. Furthermore, they may now be required to withdraw existing stock from the market.
According to market analysts, Zydus was generating an estimated $35 million in quarterly sales from its Mirabegron product, while Lupin had estimated quarterly revenue in the range of $25–30 million.
Lupin had initially launched its version of Myrbetriq after receiving a favorable decision from the US Food and Drug Administration (USFDA), a move that was subsequently challenged by Astellas. With the latest court ruling now in favor of the innovator, the FDA approval is overridden by the patent enforcement.
Both Lupin and Zydus were among the first to introduce the 25 mg dosage of Mirabegron in the US market and had plans to launch the 50 mg dosage soon.
Myrbetriq, developed and marketed by Astellas Pharma Global Development, is a prescription drug used to treat overactive bladder (OAB) — characterised by symptoms like frequent or urgent urination and urinary incontinence. It is also approved for treating neurogenic detrusor overactivity (NDO) in pediatric patients.
Lupin shares are trading 3.13% lower at Rs 1,949.70, while the Zydus Lifesciences stock is at Rs 839.95, down 4.89%.
