Sun Pharma Gets DCGI Nod For Generic Weight-Loss Drug Amid Patent Fight With Novo Nordisk

Sun Pharmaceutical on Friday announced that it has received approval from the Drugs Controller General of India (DCGI) to manufacture and market a generic semaglutide injection for chronic weight management in adults. This version will be launched under the brand name Sematrinity after the expiry of the semaglutide patent in India.

Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist. The primary semaglutide patent for the core molecule is held by Novo Nordisk, but its key composition patent expired in India in September 2024, with a formulation patent set to expire in March 2026, opening doors for generic drug makers.

Sun Pharmaceutical, in an exchange filing, announced that the company had received DCGI approval in December 2025 to manufacture and market semaglutide injection for adults with type 2 diabetes mellitus that is not adequately controlled through diet and exercise. The injection is to be used alongside a reduced-calorie diet and increased physical activity.

The weight management version will be launched under the brand name Noveltreat after the patent expiry. DCGI approval followed a Phase III clinical trial conducted in India. Noveltreat will be available in five dose strengths—0.25 mg/0.5 mL, 0.5 mg/0.5 mL, 1 mg/0.5 mL, 1.7 mg/0.75 mL, and 2.4 mg/0.75 mL—with a recommended maintenance dose of 2.4 mg once weekly. The injection will be administered using a prefilled pen.

“Obesity and diabetes have emerged as two of the most pressing health challenges confronting India, and GLP-1-based therapies can play a meaningful role in addressing this growing burden. Noveltreat meets global quality standards and is supported by robust Indian clinical evidence on efficacy and safety for weight management,” said Kirti Ganorkar, Managing Director, Sun Pharma.

DCGI approval to Sun Pharma comes amid an ongoing patent dispute with Novo Nordisk in the Delhi High Court. The case relates to semaglutide, the active ingredient in Danish pharma giant’s drugs such as Ozempic and Wegovy. In December 2025, the Delhi High Court allowed Sun Pharma to manufacture and export its semaglutide formulation. However, the court barred domestic sales in India until the expiry of Novo Nordisk’s patent in March 2026.

The court also directed Sun Pharma to submit an affidavit and share export account details as part of its undertaking in the case.

The approval comes against a backdrop of rising metabolic disorders in India. NFHS-5 data shows nearly one in four Indians aged 15–49 is overweight or obese. The ICMR-INDIAB 17 study estimates around 101 million people in India live with diabetes, with about 64% of patients not achieving target HbA1c levels.