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Shares of Zydus Lifesciences Ltd saw a 1% increase during the early trading hours on 30 September after the company announced receiving final approval from the US Food and Drug Administration (USFDA) for its 40 mg dose of enzalutamide capsules, which is intended to treat prostate cancer.
The approval by the US FDA for enzalutamide capsules is significant since these capsules are used to treat metastatic castration-resistant prostate cancer. The enzalutamide capsules will be made in the company’s Moraiya plant in Ahmedabad.
Reportedly, the US saw $869.4 million in sales of Enzalutamide capsules in just one year. A study projects that by 2029, the combined sales of enzalutamide and its counterpart will have reached $14.2 billion.
The US Court of Appeals for the Federal Circuit’s decision earlier this month on a patent protecting Mirabegron brought attention to Zydus Life shares. The district court, which had earlier declared the patent invalid, was found to have made a mistake in its decision-making. At the moment, only two players have introduced generic Mirabegron at risk: Zydus Life and Lupin.
The original manufacturer of Mirabegron, Astellas Pharma Inc., filed a lawsuit against Zydus and Lupin to stop the generic versions from being made, alleging patent infringement. But in April 2024, a federal judge denied Astellas’ motion.
Overactive bladder (OAB) and related symptoms such as urge, urine incontinence, urgency, and frequency of urination are treated with mirabegron.
Not only were Zydus Life and Lupin among the first to release the generic version of Mirabegron to the US market in 25 mg dosages, but they are also getting ready to roll out 50 mg dosages soon.
Zydus Life’s market capitalization now exceeds Rs 1.1 lakh crore.
At 11:27 am, the shares of Zydus Lifesciences shed all their early gains and were trading 1.10% lower at Rs 1,064.10 on NSE.
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