Dr. Reddy's Semaglutide Expectations Hinged on Prompt Approvals
DRL is pinning its hopes on semaglutide, although timely approvals are crucial. While sales of semaglutide in India are restricted until the patent expires locally in March, this period allows DRL to prepare for its domestic launch. Novo Nordisk, a Danish company, currently leads the weight-loss drug market, holding the semaglutide patent. As the patent nears expiration in several countries, significant market activity is anticipated.
The court's December order aligned with its May interim order. DRL now seeks domestic sales approval from the Central Drugs Standard Control Organization (CDSCO), following a recommendation from the regulator's expert committee in September. Dr. Reddy's is currently manufacturing the injectable form of the drug and is also developing an oral version.
The company's export plans are facing delays due to approval processes. Specifically, the pharmaceutical drugs directorate of Canada issued a notice of non-compliance in response to their application. While the company has responded, approval is expected only by May or June 2026, six months after Novo Nordisk's semaglutide patent expires in Canada.
The semaglutide opportunity presents itself at a crucial time for DRL. The company anticipates considerable revenue and margin pressure after losing exclusive rights to sell Revlimid, a cancer drug, in January. The US business, which accounted for over 40% of generics revenue, experienced a 15% year-on-year decline in dollar terms during the first half of FY26, driven by price erosion and reduced Revlimid sales.
