Sun Pharma Gains Legal Clearance to Manufacture and Export Semaglutide Amid Patent Tussle
In a significant development for India’s pharmaceutical landscape, the Delhi High Court on December 10 granted Sun Pharma permission to manufacture and export semaglutide, the active ingredient used in Novo Nordisk’s globally popular diabetes and weight-loss drugs Ozempic and Wegovy. The order marks another pivotal moment in the evolving patent battle surrounding one of the world’s most sought-after GLP-1 therapies.
The decision comes less than a week after a similar ruling in favour of Dr Reddy’s Laboratories, reinforcing a growing trend that positions India as an emerging hub for semaglutide manufacturing for global markets. However, despite being allowed to manufacture and export, Sun Pharma cannot sell semaglutide-based products within India until Novo Nordisk’s formulation patent expires in March 2026.
Court Allows Export but Bars Domestic Sales Until Patent Expiry
According to details reported by CNBC-TV18, the Delhi High Court order permits Sun Pharma to begin production and export of semaglutide, subject to the company filing an undertaking that it will not sell the drug in India during the subsistence of Novo Nordisk’s patent.
The ruling mirrors the relief granted to Dr Reddy’s, indicating judicial consistency in balancing intellectual property rights with India’s role in the global generics supply chain. For Sun Pharma, the export approval opens a meaningful growth avenue in international markets where Novo Nordisk does not hold valid patent protection.
Legal experts note that the decision underscores India’s emphasis on supporting innovation while ensuring global access to essential therapies, especially in high-demand drug categories like GLP-1 agonists.
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Patent Dispute Intensifies as Indian Drugmakers Eye GLP-1 Opportunity
Novo Nordisk currently holds two patents related to semaglutide in India.
The composition patent, which expired in September 2024, paved the way for Indian pharmaceutical companies to begin developing generic versions.
The formulation and delivery patent, valid until March 2026, remains the focal point of ongoing litigation.
It is this formulation patent that bars Indian manufacturers from commercializing semaglutide within the domestic market. As a result, companies like Sun Pharma and Dr Reddy’s are currently confined to exporting the drug to territories where patent restrictions do not apply.
The expiry of the primary composition patent has triggered aggressive interest from Indian drugmakers. Analysts say the GLP-1 segment has become one of the hottest therapeutic categories globally due to surging demand for weight-loss and diabetes management drugs. With Ozempic and Wegovy witnessing multi-billion-dollar sales worldwide, generic manufacturers are eager to gain a foothold in what could become one of the largest pharmaceutical markets of the decade.
Sun Pharma Strengthens Its Position in the High-Growth GLP-1 Market
Sun Pharma, India’s largest pharmaceutical company by market capitalization, has long indicated its intention to enter the GLP-1 product category. The High Court’s approval now arms the company with the ability to begin manufacturing and exporting semaglutide, a move that could strengthen its position in several international markets.
The ability to export semaglutide gives Sun Pharma early visibility and supply chain readiness before the formulation patent expires in India. This head start could offer competitive advantages when the drug becomes eligible for domestic commercialization in March 2026.
Industry experts believe that India may soon emerge as a key manufacturing hub for GLP-1 therapies as multiple domestic players ramp up production capabilities. The demand for weight-loss treatments has surged globally, stretching supply chains and creating opportunities for cost-efficient producers.
What This Means for Investors and the Pharmaceutical Sector
For investors, Sun Pharma’s entry into the semaglutide export market signals a promising strategic development. Although the company cannot sell the drug in India yet, export revenue potential in non-patent markets could contribute meaningfully to future earnings.
Additionally, the broader Indian pharmaceutical industry stands to benefit from increased participation in GLP-1 generics—a category projected to grow exponentially over the next decade.
Key investor takeaways include:
Export-led growth potential: Sun Pharma can begin building scale well before domestic commercialization becomes possible.
Patent clarity: Orders for both Sun Pharma and Dr Reddy’s suggest courts are taking a consistent stance in balancing patent rights and generics manufacturing.
Strategic positioning: India may become a preferred global supplier of semaglutide APIs and formulations.
Long-term growth story: The GLP-1 opportunity aligns with global healthcare trends around obesity, metabolic disorders, and chronic disease management.
Conclusion: A Defining Moment in India’s Semaglutide Play
The Delhi High Court’s decision to allow Sun Pharma to manufacture and export semaglutide marks a critical juncture in India’s pharmaceutical evolution. As patent disputes continue and global demand for GLP-1 therapies intensifies, Indian companies are positioning themselves to play a pivotal role in supplying one of the world’s most valuable drug categories.
While domestic sales will have to wait until 2026, Sun Pharma’s legal clearance sets the stage for a broader transformation in the generics landscape—and investors will be closely watching how this opportunity unfolds.
