On Monday, Zydus Lifesciences said it received the USFDA’s (United States Food and Drug Administration) final nod to market its version of Mirabegron extended-release tablets with 180 days of shared generic drug exclusivity. Mirabegron tablets are used to treat overactive bladder. The final approval granted by the USFDA to the firm’s US arm Zydus Pharmaceuticals Inc is for the tablets of strengths 25 mg and 50 mg.

As per the reports, Zydus Lifesciences was one of the first applicants to submit a substantially complete ANDA (abbreviated new drugs application) with a paragraph IV certification for Mirabegron (25 mg and 50 mg) extended-release tablets. It is, therefore, eligible for 180 days of shared generic drug exclusivity for the drug.

Mirabegron is used to treat overactive bladder (OAB) with symptoms of urinary incontinence, urinary urgency and frequency. The drug would be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ.
Founded by Ramanbhai Patel in 1952, Zydus Lifesciences Limited was formerly known as Cadila Healthcare Limited. It is a multinational pharmaceutical company primarily engaged in manufacturing generic drugs.

Headquartered in Ahmedabad, it ranked 100th on the Fortune India 500 list in 2020. As per IQVIA MAT August 2022 data, Zydus stated Mirabegron extended-release tablets 25mg and 50mg had annual US sales of USD 2.42 billion.