Dr Reddy's Labs Secures Approval for Generic Semaglutide Tablets in India
Dr Reddy's gets nod to roll out generic oral semaglutide drug
The Economic TimesImage: The Economic Times
Dr Reddy's Laboratories, based in Hyderabad, India, has received final approval from the Central Drug Standard Control Organisation (CDSCO) to manufacture and sell generic semaglutide tablets, a drug used for weight loss and diabetes management. This approval follows the expiration of the core semaglutide patent in India, although Novo Nordisk's patent on oral formulations remains until 2031.
- 01Dr Reddy's has received CDSCO approval for generic semaglutide tablets.
- 02The approval comes after the core semaglutide patent expired in India.
- 03Novo Nordisk is currently involved in a patent infringement dispute with Indian drugmakers.
- 04Dr Reddy's formulation has been clinically validated as non-inferior to Novo's product.
- 05The generic drug will be manufactured in Andhra Pradesh, India.
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Dr Reddy's Laboratories has officially received approval from India's Central Drug Standard Control Organisation (CDSCO) to manufacture and market generic versions of semaglutide tablets, a medication widely used for weight loss and diabetes management. This approval follows the expiration of the core semaglutide patent in India last month, although Novo Nordisk's patent on oral formulations remains valid until 2031. The Danish pharmaceutical company sells the original formulation under the brand name Rybelsus. Dr Reddy's confirmed that its product was clinically evaluated in India, demonstrating non-inferiority to the innovator's formulation. The approval marks a significant development in the competitive landscape of the weight-loss and anti-diabetes drug market, which has surpassed the ₹1,600 crore mark in just over a year. Despite the approval, Novo Nordisk has filed a lawsuit in the Delhi High Court, alleging that Dr Reddy's and Torrent Pharma have infringed on its patent through their formulations. The Indian companies contend that their drugs utilize different levels of salcaprozate sodium (SNAC), a technology that enhances drug absorption, thus not violating Novo's patent. Dr Reddy's has received approval for three oral compositions: 3 mg, 7 mg, and 14 mg, which are intended to improve glycaemic control in adults with type-2 diabetes. The raw material for the drug will be sourced from Hangzhou Zhongemeihuadong Pharma Jiangdong Co, while the tablets will be manufactured in Andhra Pradesh, India.
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The approval of Dr Reddy's generic semaglutide tablets could lead to increased competition in the diabetes and weight-loss medication market, potentially lowering prices for consumers.
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