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Zydus Launches Extended-Release Mirabegron Tablets in the US

Tuesday, April 23, 2024

Zydus Lifesciences Limited, alongside its subsidiaries/affiliates (hereafter referred to as "Zydus"), has launched Mirabegron Extended-Release Tablets, 25 mg in the US market. This follows the company's prior receipt of final approval from the United States Food and Drug Administration (USFDA) for marketing Mirabegron Extended-Release Tablets USP 25 mg and 50 mg (USRLD: Myrbetriq® Extended-Release Tablets). Zydus stands among the pioneering suppliers launching the generic version of Mirabegron Extended-Release Tablets, USP 25 mg in the US market, with plans to introduce Mirabegron Extended-Release Tablets, 50mg shortly.

Mirabegron is specifically indicated for addressing overactive bladder (OAB) symptoms such as urge urinary incontinence, urgency, and urinary frequency. Manufacture of the drug will take place at the group’s formulation manufacturing facility in Ahmedabad SEZ, India.

Expressing his thoughts on the launch, Dr. Punit Patel, CEO Americas, stated, “Being among the initial suppliers, we are delighted to launch the generic Mirabegron, thus enhancing accessibility and availability of the generic product for patients in the US market. This launch marks a significant milestone for us and reinforces our growth strategies in the US market for the current fiscal period.”

Mirabegron Extended-Release Tablets USP 25mg and 50mg achieved annual sales of USD 2.42 billion in the US (IQVIA MAT February 2024).

With 393 approvals under its belt, the group has filed over 460* ANDAs since the inception of the filing process in FY 2003-04.



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