Dr. Reddy’s Laboratories has informed the Delhi High Court that it will manufacture and export the weight-loss drug semaglutide but will not sell it within India. This decision comes amid ongoing legal proceedings concerning patent rights and market exclusivity.
Background
Semaglutide, marketed globally as Ozempic and Wegovy by Danish pharmaceutical company Novo Nordisk, has gained significant attention for its effectiveness in weight management. In October 2023, Dr. Reddy’s received approval from India’s drug regulatory authority to conduct a bioequivalence study for semaglutide, aiming to establish its safety and efficacy for the Indian population. The company had initially sought a waiver for this study and a Phase III clinical trial but was advised by the Subject Expert Committee to proceed with the bioequivalence study .
Legal Developments
A significant legal confrontation emerged when Novo Nordisk filed a patent infringement lawsuit against Dr. Reddy’s Laboratories and OneSource Specialty Pharma, accusing them of unauthorized sales of semaglutide in the Indian market. In response, the Delhi High Court issued an order restraining both companies from selling the drug domestically until further notice. The next court hearing on the matter is scheduled for August 19, 2025 .
The Economic Times
Company’s Position
In light of these legal proceedings, Dr. Reddy’s has clarified that it will not engage in the sale of semaglutide within India. Instead, the company plans to manufacture the drug for export purposes, adhering to the provisions of Section 107A of the Indian Patents Act, which allows for the manufacture and export of patented drugs without infringing on the patent holder’s rights.
Industry Implications
The decision to manufacture and export semaglutide without selling it domestically highlights the complexities pharmaceutical companies face in navigating patent laws and market exclusivity. While Dr. Reddy’s aims to capitalize on the global demand for weight-loss medications, the ongoing legal challenges underscore the importance of securing patent rights and navigating regulatory approvals in each market.
Conclusion
As the legal proceedings continue, Dr. Reddy’s Laboratories remains committed to complying with Indian patent laws while exploring opportunities in international markets. The outcome of the upcoming court hearing will likely have significant implications for the company’s strategy concerning semaglutide in India.