Zydus gets tentative U.S. FDA nod for generic diabetes drug; stock ends marginally higher
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Zydus Lifesciences on Wednesday said it has received tentative approval from the United States Food and Drug Administration (USFDA) to market Dapagliflozin Tablets, 5 mg and 10 mg, in the US. The drug is used for improving glycaemic control in adults with type 2 diabetes.
Following the announcement, shares of Zydus Lifesciences ended 0.23% higher at ₹905.05 on the BSE, taking the company’s market capitalisation to ₹91,069.21 crore.
Dapagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise for managing type 2 diabetes. The company said the tablets will be manufactured at its formulation facility located in the SEZ at Ahmedabad.
According to IQVIA data, Dapagliflozin tablets recorded annual sales of $10.49 billion in the United States for the 12-month period ending December 2025.
With this, the group now has 430 approvals and has filed 505 ANDAs since it began the filing process in FY2003-04.
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Launched the world’s first biosimilar of Nivolumab
Last month, Zydus launched the world’s first biosimilar of Nivolumab in India under the brand name Tishtha, strengthening its presence in biologics and immuno-oncology. The therapy is available in 100 mg and 40 mg doses priced at ₹28,950 and ₹13,950, respectively—about one-fourth the cost of the reference drug—aimed at improving affordability and treatment access for cancer patients.
Speaking on the development, Zydus Lifesciences Managing Director Sharvil P. Patel said the company remains focused on expanding access to affordable and advanced therapies while ensuring consistent treatment availability for patients.
Systematix upgraded Zydus to a ‘Buy’
Recently, brokerage firm Systematix upgraded Zydus Lifesciences to a ‘Buy’ rating and revised its target price to ₹1,038 per share, citing growth potential from new product launches and specialty drug expansion.
The upgrade follows recent developments at Sentynl Therapeutics, a subsidiary of Zydus Lifesciences, which secured U.S. FDA approval for its Menkes disease drug candidate, Copper Histidinate, under the brand name Zycubo. The drug expands Sentynl’s ultra-rare disease portfolio and significantly widens its addressable patient population.
Menkes disease is an ultra-rare genetic disorder diagnosed in newborns, with around 56 cases reported annually in the United States. If untreated, the median survival is less than 18 months. Zycubo is currently the first and only approved treatment for the condition and has shown a substantial improvement in survival rates. Clinical trials showed that early treatment within 10 days of birth extended survival to 177 months, compared with 62 months when treatment was initiated after four weeks.
Systematix estimates Zycubo’s peak sales potential at around $50 million, assuming a net price realisation of $600,000 per patient annually and a 50% adoption rate among eligible patients. Zydus has in-licensed Zycubo from Cyprium Therapeutics and will pay tiered royalties and milestone-linked payments.
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