Zydus Lifesciences, a leading player in the pharmaceutical industry, has announced a significant milestone in its global operations with the launch of Mirabegron Extended-Release Tablets, 25 mg in the United States market. This development comes after the company received final approval from the United States Food and Drug Administration (USFDA) to market Mirabegron Extended-Release Tablets USP 25 mg and 50 mg, which are the generic versions of Myrbetriq Extended-Release Tablets.
Zydus Lifesciences is among the first suppliers to introduce the generic version of Mirabegron Extended-Release Tablets, USP 25 mg in the US market and is poised to launch Mirabegron Extended-Release Tablets, 50 mg in the near future. Mirabegron, indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency, holds significant promise in addressing critical healthcare needs.
The manufacturing of Mirabegron Extended-Release Tablets will take place at Zydus’ formulation manufacturing facility in Ahmedabad SEZ, India. Dr. Punit Patel, CEO Americas, expressed satisfaction with the launch, emphasizing its potential to enhance access and availability of the generic product for patients in the US market. He underscored the launch as a significant milestone that aligns with the company’s growth plans in the US market for the current fiscal year.
Mirabegron Extended-Release Tablets USP 25 mg and 50 mg have shown substantial market potential, with annual sales reaching $2.42 billion in the US as of February 2024 (IQVIA MAT). This launch underscores Zydus’ commitment to expanding its portfolio and addressing unmet medical needs in key therapeutic areas.
The Zydus Group, with 393 approvals and over 460 ANDAs filed since the inception of the filing process in FY 2003-04, continues to demonstrate its leadership in the pharmaceutical domain. Zydus Lifesciences, a discovery-driven global lifesciences company, is dedicated to discovering, developing, manufacturing, and marketing a broad range of healthcare therapies.
In its recent financial report, Zydus Lifesciences showcased strong performance, reporting a 26.76% increase in consolidated net profit to Rs 789.6 crore and a 5.83% rise in revenue from operations to Rs 4,343.70 crore in Q3 FY24 over Q3 FY23. These figures highlight the company’s resilience and strategic focus on driving sustainable growth amidst evolving market dynamics.
As Zydus Lifesciences expands its presence in the US market with the launch of Mirabegron Extended-Release Tablets, it reaffirms its commitment to delivering high-quality, affordable healthcare solutions to patients globally. This milestone not only strengthens Zydus’ position in the pharmaceutical industry but also underscores its dedication to advancing healthcare outcomes and improving patient lives.