Zydus Introduces Generic Drug for Overactive Bladder in US Market

Zydus Lifesciences, an India-based pharmaceutical company, announced the availability of a generic treatment for overactive bladder in the US market. Zydus stated in a regulatory filing that the company has launched Mirabegron extended-release tablets in the strength of 25 mg in the US market following final approval from the US Food and Drug Administration (USFDA). 

Zydus is one of the first suppliers to introduce the generic Mirabegron extended-release tablets (USP 25 mg) to the US market. It also said the pharmaceutical company is preparing to introduce 50 mg tablets.

Mirabegron is showcased for the treatment of Overactive Bladder (OAB), with symptoms of urge urinary incontinence, frequency of urination and urgency.

According to the pharmaceutical company, the product will be manufactured at the formulation manufacturing facility of the Zydus group in Ahmedabad SEZ, India. Punit Patel, CEO of Zydus Americas, stated that introducing generic Mirabegron will increase the generic product's accessibility to 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," he added.

The IQVIA MAT data show that Mirabegron extended-release tablets (USP 25mg and 50mg) sold for USD 2.42 billion annually in the United States. On the BSE, Zydus shares were trading at Rs 948.90 each, an increase of 2.9%.