Dr Reddy’s Wins Approval for Generic Ozempic in India, Targets 12 Million Pens in First Year
Regulatory clearance marks a major step into the booming diabetes and weight-loss drug market
Dr Reddy’s Laboratories has received regulatory approval in India to manufacture and sell a generic version of Ozempic, a widely used diabetes medication based on the active ingredient Semaglutide. The approval positions the company to tap into one of the fastest-growing therapeutic segments, with management targeting sales of 12 million injectable pens in the first year of launch.
The clearance from India’s drug regulator allows Dr Reddy’s to introduce the generic product for diabetes treatment. However, the company is still awaiting approval for the obesity-focused version, commonly associated with the weight-loss therapy Wegovy.
Semaglutide Patent Expiry Opens New Opportunities
The approval comes ahead of the global patent expiry for Semaglutide, scheduled for March 2026. Once the patent protection ends, Indian pharmaceutical companies are expected to intensify competition in both diabetes and weight-management therapies.
Semaglutide has gained significant attention globally not only for diabetes management but also for its appetite-suppressing properties, which have driven strong off-label use for weight loss. This dual demand has made the molecule a strategic growth driver for generic drugmakers.
Strong Demand Expected in Domestic and Overseas Markets
Dr Reddy’s management has indicated that the company has adequate manufacturing capacity to meet anticipated demand. The firm plans to collaborate with local partners in India to support distribution and market penetration.
Beyond the domestic market, Dr Reddy’s also plans to launch Semaglutide in Canada later this year, followed by other emerging markets. These launches are expected to strengthen the company’s branded generics portfolio and support long-term revenue growth.
India Business Shows Solid Growth Momentum
Semaglutide is expected to play a key role in accelerating Dr Reddy’s India business, which has been expanding through new product launches and strategic acquisitions. During the latest quarter, revenue from the company’s India operations rose 19% year-on-year to ₹16.03 billion.
This growth was supported by selective price increases and contributions from recently acquired brands, including an anti-vertigo therapy added to its domestic portfolio in September.
Quarterly Financial Performance Beats Expectations
For the quarter ended December 31, Dr Reddy’s reported a 14.4% decline in consolidated net profit to ₹12.1 billion. Despite the drop, the result exceeded market expectations, which had projected a sharper fall.
Total revenue from operations increased 4.4% year-on-year to ₹87.53 billion, comfortably ahead of estimates. The profit decline marked the company’s first quarterly contraction in five quarters.
Key Headwinds Impacting Profitability
- Slower sales of Lenalidomide, a generic cancer drug, in the US market
- Increased pricing pressure due to heightened competition
- Normalization of earnings following earlier high-margin periods
Outlook: Semaglutide as a Long-Term Growth Engine
While near-term earnings faced pressure, the approval for generic Ozempic significantly strengthens Dr Reddy’s medium- to long-term outlook. With diabetes and obesity rates rising steadily in India and abroad, Semaglutide-based therapies are expected to remain in high demand.
The company’s early regulatory clearance, manufacturing readiness, and international expansion plans could provide a meaningful boost to revenues once large-scale launches commence.
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