Sun Pharma Secures Regulatory Approval for Generic Weight-Loss Injection
Sun Pharmaceutical Industries Ltd has achieved a significant milestone in the Indian pharmaceutical landscape by obtaining approval from the Drugs Controller General of India (DCGI) to manufacture and market a generic version of semaglutide injection specifically designed for weight management. The company announced this development on Friday, revealing strategic plans to introduce the product to the market in March, coinciding with the expiration of the drug's patent protection.
Noveltreat: A New Contender in Weight Management
The generic semaglutide injection will be commercialized under the brand name Noveltreat, offering five distinct dosage options that mirror the specifications of the innovator drug Wegovy, originally developed by Novo Nordisk. This alignment in dosing aims to provide patients with a familiar and effective treatment regimen while enhancing accessibility through generic pricing.
Semaglutide functions as a glucagon-like peptide-1 (GLP-1) receptor agonist, a class of medications approved for chronic weight management in adults. With its patent exclusivity in India set to conclude in March, the pharmaceutical industry is witnessing a surge of activity as multiple generic drugmakers prepare to launch their versions, intensifying competition in the weight-loss drug segment.
Competitive Landscape and Regulatory Approvals
In a parallel move, rival pharmaceutical firm Dr Reddy's Laboratories Ltd confirmed on 21 January that it has also received regulatory approval for its generic semaglutide formulation. The company's management has outlined ambitious targets, aiming to produce and distribute approximately 12 million pens within the first year of launch, signaling a robust entry into this burgeoning market.
Furthermore, Sun Pharma had previously secured regulatory approval in December 2025 to manufacture and market semaglutide for the treatment of type-2 diabetes. This product is slated for launch under the brand name Sematrinity, positioning the company as a comprehensive provider in the cardiometabolic therapy domain. Notably, Novo Nordisk markets its semaglutide injection for type-2 diabetes under the brand name Ozempic, highlighting the expanding applications of this versatile drug.
Commitment to Quality and Accessibility
Kirti Ganorkar, Managing Director of Sun Pharma, emphasized the company's dedication to upholding high standards and improving patient access. "Noveltreat meets global quality standards and is supported by robust Indian clinical evidence on efficacy and safety for weight management. As India's largest pharmaceutical company with leadership in cardiometabolic therapies, we are committed to improving access to generic semaglutide across the country after the patent expiry," Ganorkar stated, underscoring the strategic importance of this launch.
Currently, Sun Pharma, Dr Reddy's Laboratories, and Alkem Laboratories Ltd stand as the only Indian drugmakers to have received regulatory approval for generic semaglutide. However, the landscape is poised for expansion, with several other pharmaceutical companies awaiting approvals and expressing intent to launch their versions as early as March, potentially transforming the market dynamics.
Manufacturing and Export Initiatives
In anticipation of the patent expiry, Sun Pharma and Dr Reddy's have proactively initiated manufacturing and export activities for generic semaglutide to non-patent markets. This move follows a favorable nod from the Delhi High Court in December, enabling these companies to capitalize on international opportunities while preparing for domestic rollout.
Market Pricing and Competitive Analysis
The current pricing structure for weight-loss drugs in India presents a stark contrast that generic versions aim to address. Novo Nordisk's Wegovy is priced at ₹13,850 per month for the 0.5mg and 1mg doses, with higher doses costing ₹16,400 each. Meanwhile, Eli Lilly's Mounjaro, which commands a significant share of the Indian weight-loss drug market, ranges from ₹14,000 per month for the 2.5mg dose to ₹27,500 for the 15mg dose. The introduction of generic alternatives like Noveltreat is expected to drive down costs, making weight management therapies more affordable and accessible to a broader population.
This development marks a pivotal moment in India's pharmaceutical industry, as companies leverage regulatory approvals and patent expirations to enhance treatment options and foster competitive pricing in the critical area of weight management and cardiometabolic health.
