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Regulatory delays stall generic Semaglutide approval

* The additional information/clarification requirement by the Canadian health regulator from DRRD prolongs the prospects of Ozempic’s generic version (Semaglutide injection).

* Considering the time required to submit required information, time taken by the regulator to review the application, and the year end period, this delay has weakened the scope of Semaglutide injection business from the Canadian market in 4QFY26.

* Considering market potential and DRRD being an early filer, we have estimated revenue of USD75-80m/USD350m from this product in 4QFY26/FY27 in different markets (2%/8% of FY26E/FY27E revenue).

* We await clarity about the approval process for potential markets, including Canada.

Canada: A potential hotbed for early generic GLP1 opportunity

* Semaglutide, a GLP-1 receptor agonist developed by Novo Nordisk, has emerged as a transformative therapy for type-2 diabetes and obesity.

* Semaglutide, under the brand Ozempic, has annual sales of USD1.6b in the Canadian market. Ozempic is used to treat diabetes. Novo Nordisk sells Semaglutide under the brand Wegovy for weight management.

* Both Ozempic/Wegovy have recorded exceptional growth, although chronic shortages continue to constrain demand.

The race to market generics in full swing

* Multiple companies are working on the approval process for the generic version of Semaglutide. The patent related to Ozempic for the Canadian market will expire on 4th Jan’26.

* DRRD - first generic filer in Canada; currently addressing Health Canada’s NOC.

* Sandoz – filed the application in Nov’24 and is under review.

* Apotex – submitted the application in Jan’25 and is under review.

* Taro/Aspen/Teva – recent filers (Jun’25/Aug’25/Aug’25).

* While the product patent for Ozempic is expiring in Jan’26, we await clarity on device-related IP and any other manufacturing barriers that could delay the generics entry in potential markets.

Regulatory setback – A speed-breaker for generic launch by DRRD

* DRRD has received NOC from Health Canada for its abbreviated new drug submission (ANDS) for a Semaglutide injection.

* The timing of additional queries is in fact quite notable. DRRD was positioned as the first generic filer and had been preparing for a Jan’26 launch. As per management, the annualized revenue expectation is ~USD300m in the initial phase from Canada’s Semaglutide market, if launched alone by DRRD.

* The notice delays the company’s scope to capture the early-market opportunity. DRRD would be working on providing the required information to address the issue at the earliest.

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