Lupin Unleashes Affordable Overactive Bladder Treatment in the U.S. Market

Mumbai-headquartered Lupin Limited, a global pharmaceutical powerhouse, has announced a pivotal moment for patients in the United States: the launch of its Mirabegron Extended-Release Tablets. This highly anticipated generic medication is set to revolutionize access to treatment for overactive bladder (OAB), offering a more affordable and widely available alternative to Astellas Pharma Global Development Inc.'s well-known Myrbetriq® Extended-Release Tablets.

The introduction of Lupin's Mirabegron ER, available in both 25 mg and 50 mg strengths, brings welcome relief to the millions of Americans grappling with the challenging symptoms of OAB, including urgent urinary incontinence, frequent urination, and a persistent sense of urgency.

This move underscores Lupin's commitment to making essential medicines more accessible and affordable, thereby improving patient outcomes across the healthcare spectrum.

This significant launch follows a rigorous approval process, with Lupin having successfully secured the U.S. Food and Drug Administration (FDA)'s green light for its Abbreviated New Drug Application (ANDA) for Mirabegron Extended-Release Tablets.

This regulatory clearance is a testament to Lupin's dedication to quality and safety, ensuring that patients receive a generic product that meets the same high standards as its branded counterpart.

The market for overactive bladder treatments is substantial, with Mirabegron Extended-Release Tablets (including branded versions) registering an estimated annual sales figure of a staggering USD 2.3 billion in the U.S.

for the 12 months ending June 2023, according to insightful data from IQVIA MAT. Lupin's strategic entry into this lucrative and critical therapeutic area is poised to create a significant impact, offering a much-needed cost-effective solution without compromising on efficacy or safety.

Lupin, renowned for its innovative spirit and extensive global footprint, continues to be a driving force in the pharmaceutical industry.

With its headquarters in Mumbai, India, the company excels in the development and commercialization of a diverse portfolio, including branded and generic formulations, cutting-edge biotechnology products, and Active Pharmaceutical Ingredients (APIs) worldwide. Its strong presence in key therapeutic segments such as cardiovascular, anti-diabetic, anti-asthma, pediatric, anti-infective, and women's health further solidifies its position as a leader dedicated to global health.