First wave of generic semaglutide approvals opens up India market

India has entered the first phase of generic semaglutide approvals, with CDSCO clearing multiple formulations for obesity and diabetes, paving the way for lower-cost GLP-1 therapies

India has entered the first phase of regulatory approvals for generic semaglutide, with multiple domestic drugmakers securing clearances for obesity and metabolic disease therapies. The move paves the way for lower-cost alternatives once patent protections lapse.

 

Semaglutide is a blockbuster GLP-1 receptor agonist innovated by Novo Nordisk and is set to go off patent in March.

 

Over the past few months, the Central Drugs Standard Control Organisation (CDSCO) has cleared a wide range of semaglutide formulations for chronic weight management and type-2 diabetes, granted between September and December 2025.

 

On Friday, Sun Pharmaceutical said it had received approval from the Drugs Controller General of India (DCGI) to manufacture and market a generic semaglutide injection for chronic weight management, marking one of the first formal announcements linked to the latest regulatory clearances. Sun Pharma said it would launch the product under the brand name Noveltreat after the expiry of semaglutide’s patent in India.

 

With this, companies that have received bulk drug and finished formulation approvals include Sun Pharma, Zydus Lifesciences, Alkem Laboratories, and Dr Reddy’s Laboratories, in addition to approvals for Novo Nordisk’s Ozempic, Wegovy, and oral semaglutide Rybelsus.

 

Sun Pharma said the approval followed the successful review of a Phase III clinical trial conducted in India. Noveltreat will be offered in five dose strengths — 0.25 mg, 0.5 mg, 1 mg, 1.7 mg and 2.4 mg — administered once weekly through a prefilled pen, with 2.4 mg as the maintenance dose.

 

Multiple manufacturers have lined up their launches. Earlier this month, CDSCO approved finished injectable semaglutide formulations for chronic weight management from Zydus Lifesciences, Sun Pharma and Alkem Laboratories, across a broad range of concentrations and dosing strengths.

 

These products are intended for adults who are obese (BMI 30 or above) or overweight (BMI 27 or above) with at least one weight-related condition such as high blood pressure, diabetes or high cholesterol, and are to be used alongside a reduced-calorie diet and increased physical activity.

 

Sun Pharma alone received approvals for several solution-for-injection strengths ranging from 0.5 mg/ml to 3.2 mg/ml. Alkem was cleared for step-up doses commonly used in obesity therapy, including 0.25 mg, 0.5 mg, 1 mg, 1.7 mg and 2.4 mg, while Zydus received approval for a 15 mg/3 ml injectable formulation.

 

The approvals come with standard restrictions, including warnings against co-administration with other GLP-1 receptor agonists and limited safety data in patients with a history of pancreatitis.

 

Sun Pharma has said it would also launch semaglutide for diabetes under the brand Sematrinity after patent expiry.

 

India represents a large and rapidly growing opportunity for GLP-1 therapies. According to the National Family Health Survey-5, nearly one in four Indians aged 15-49 is overweight or obese, while the ICMR-INDIAB study estimates that more than 101 million people in the country live with diabetes. 

Cipla exploring semaglutide entry after patent expiry

 

Cipla is exploring the opportunity to enter the semaglutide market as the patent expires in March, with Managing Director and Global CEO (designate) Achin Gupta saying, “We have possibilities to explore on semaglutide, but we would rather wait and watch how the market evolves before deciding on our entry into that space.”

 

The company has entered the obesity space in India through its partnership with Eli Lilly’s Mounjaro (tirzepatide).

 

Cipla said that its current focus is on tirzepatide, given its long patent life and differentiated profile, while it will adopt a wait-and-watch approach on semaglutide as the market evolves and pricing becomes clearer. While GLP-1 products are expected to make a meaningful contribution to revenue, Cipla said margins will be lower than core in-house products due to the in-licensing model, and the company will balance growth with profitability.