Zydus Lifesciences launches Mirabegron Extended-Release Tablets in US market

Zydus Lifesciences Limited has announced the launch of Mirabegron Extended-Release Tablets, 25 mg, in the US market, following the final approval from the United States Food and Drug Administration (USFDA). This introduction marks Zydus as one of the first suppliers to offer the generic version of this medication, which is primarily used for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. The company is also set to launch a 50 mg dosage of the same medication shortly.

Mirabegron Extended-Release Tablets have shown substantial market success, with annual sales reaching USD 2.42 billion in the US, according to IQVIA MAT data as of February 2024. Zydus’s entry into this market segment is expected to enhance the availability of this essential medication, making it more accessible to patients across the United States. This launch is aligned with Zydus’s strategic growth plans in the US pharmaceutical market for the current fiscal year.

The newly launched generic drug will be manufactured at Zydus’s formulation manufacturing facility located in the Ahmedabad SEZ, India. This facility is equipped to meet large-scale production demands while adhering to the stringent quality standards required by USFDA for pharmaceutical products.

Dr. Punit Patel, CEO Americas of Zydus, expressed optimism about the launch, stating, “As one of the first suppliers, we are pleased with the launch of generic Mirabegron which will improve access and availability of the generic product for patients in the US market. This is a significant launch for us which will strengthen our growth plans in the US market in the current fiscal.”

The launch of Mirabegron Extended-Release Tablets is part of Zydus’s broader strategy to expand its portfolio in the US market. The company now boasts 393 approvals and has filed over 460 Abbreviated New Drug Applications (ANDAs) since the commencement of its filing process in the fiscal year 2003-04.

The introduction of a generic version of Mirabegron by Zydus is likely to have a positive impact on the healthcare market, particularly for patients dealing with OAB. By providing a more affordable generic option, Zydus is set to compete effectively with existing brands and enhance its market share. This strategic move not only underscores Zydus’s commitment to broadening patient access to important medications but also highlights its capability in leveraging robust R&D and manufacturing capabilities to meet market needs.