Zydus Life gains over 3% on launch of bladder control drug

Incred Equities estimates Mirabegron to be a $75-80 million opportunity for Zydus Lifesciences, as the company also enjoys a 180-day exclusivity period

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Shares of Zydus Lifesciences rose over 3 percent in the morning trade on April 22 after the pharma company launched the generic version of bladder control drug Mirabegron in the US.

At 11.47 am, shares of Zydus Life were trading at Rs 951.85 on the National Stock Exchange.

Mirabegron is used in the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and urinary frequency. The company is among the first to launch the generic version in 25 mg dosages in the US market and is prepared to launch 50mg dosages imminently, it said.

Brokerage firm Incred Equities said the launch is as a positive surprise. Since the company is among one of the first suppliers, Incred said the drugmaker will be eligible for 180 days of shared generic drug exclusivity for Mirabegron.

Mirabegron had an annual sale of $2.42 billion in the US (both 25 mg and 50 mg), according to IQVIA data (IQVIA MAT February 2024).

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The market is equally split between 25 mg and the 50 mg versions. “If the current two generics (Zydus Lifesciences and Lupin) dynamics prevail, this can be a material opportunity for both companies,” the brokerage said. It estimated the product opportunity to be around  $75-80 million for Zydus Lifesciences ( around Rs 4 a share to EPS) and around $30-35 million for Lupin during the exclusivity period.

The company got the US Food and Drug Administration’s nod for the 25 mg and the 50 mg dosages in October 2022. So far, only Lupin and Zydus Life have launched their generic versions of the drug.

“There are six-seven other filers including Aurobindo Pharma, Alkem Labs, Teva and Sandoz. However, only Lupin, Zydus Lifesciences, and Alkem Labs have received final approvals on the product, while Aurobindo Pharma has a tentative approval,” Incred Equities said.

Zydus Lifesciences’ business trajectory will shift materially over the next two years, with gross margin holding up well and a strong recovery in India/Emerging Markets, Incred said. It has has an “add” call on the stock with a target price of Rs 974.

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