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Zydus, Lupin Shares: Systematix Retains Hold, Cuts Target Price Over US Court Ruling In Myrbetriq Patent Case
Lupin, Zydus Life had filed ANDAs with the USFDA to market generic versions of Myrbetriq, specifically the 25 mg dosage; they had plans to launch the 50 mg dosage soon.
17 Apr 2025, 10:39 AM IST 
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Myrbetriq (mirabegron), developed by Astellas Pharma, treats overactive bladder, easing symptoms like urinary incontinence, urgency, and frequent urination.
(Source: Milivigerova/ pexels)
On April 15, 2025, US District Court for the District of Delaware ruled in favor of Astellas Pharma, upholding its US Patent No. 10,842,780 for Myrbetriq (mirabegron). This blocks the sale of generic versions (25 mg and 50 mg) of the brand in the US by Lupin and Zydus Life, until the patent expires in March 2030. Lupin and Zydus Life had challenged the patent’s validity via Paragraph IV certifications in their FDA ANDA filings. While...
