Zydus Lifesciences launches Mirabegron extended-release tablets in US for treatment of overactive bladder

Zydus Lifesciences announced on Monday it has launched Mirabegron extended-release tablets, 25 mg in the US market. The drug, which is indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and urinary frequency, will be manufactured at the group’s formulation manufacturing facility in Ahmedabad, India.

Zydus Lifesciences said it had earlier received final approval from the United States Food and Drug Administration (USFDA) to market Mirabegron extended-release tablets USP 25 mg and 50 mg. The company claimed it is among the first suppliers to launch the generic version of Mirabegron extended-release tablets, USP 25 mg in the US market and is prepared to launch the 50mg version imminently.

Mirabegron extended-release tablets USP 25mg and 50mg had annual sales of $2.42 billion in the US.

Punit Patel, CEO, Americas, Zydus Lifesciences the launch will strengthen the company’s growth plans in the US market in the current fiscal.

Zydus stated in the release the group now has 393 approvals and has so far filed over 460 abbreviated new drug applications (ANDAs) since the commencement of the filing process in FY04.

During the third quarter of fiscal year 2024 (FY24), the company had reported a 6% increase in its operating revenue at ₹4,505.2 crore. Earnings before interest, tax, depreciation and amortisation (EBITDA) grew 15% year-over-year (y-o-y) to ₹1,102.4 crore. EBITDA margin for the quarter improved 200 basis points y-o-y to 24.5%.

Net profit rose 27% y-o-y to ₹789.6 crore during the quarter. Zydus had stated that capex for the quarter stood at ₹213.7 crore.

The company’s formulation business registered a 16% growth in its revenues at ₹1,427.3 crore. The business had accounted for 33% of its consolidated revenues, Zydus had said. At the same time, branded formulations business grew 17% y-o-y.

Shares of Zydus Lifesciences have gained over 32% since the beginning of the year. The stock has risen over 79% in the last one year.