Published Apr 29, 2026 | 2:06 PM ⚊ Updated Apr 29, 2026 | 2:06 PM
Dr Reddy's.
Synopsis: Health Canada has given market authorisation for Dr Reddy’s Laboratories for its generic semaglutide injection. The drug carries the same active molecule as Novo Nordisk’s Ozempic, the weekly injection that transformed diabetes treatment and sparked a worldwide demand surge. The authorisation covers two dosage strengths.
Hyderabad-based pharma Dr Reddy’s Laboratories received market authorisation from Health Canada, the health and safety agency of Canada, on 29 April 2026 for its generic semaglutide injection.
Dr Reddy’s becomes the first company anywhere in the G7 to receive this authorisation. Health Canada completed its review ahead of its 180-day target, a detail the department noted specifically in its announcement.
The drug carries the same active molecule as Novo Nordisk’s Ozempic, the weekly injection that transformed diabetes treatment and sparked a worldwide demand surge.
The authorisation covers two dosage strengths. The first is 2 mg per pen at 1.34 mg per mL. The second is 4 mg per pen at the same concentration. Both are indicated for once-weekly treatment of adult patients with type 2 diabetes.
“The approval of our generic semaglutide injection by Health Canada represents a significant milestone in our GLP-1 journey,” said Erez Israeli, chief executive of Dr Reddy’s. “As the first company to receive market authorisation for generic semaglutide injection in Canada, we remain dedicated to expanding access to high-quality, affordable GLP-1 treatments for patients with diabetes in the country.”
Israeli added that the company’s in-house development capabilities position it to ensure a reliable and consistent supply. “This approval further fortifies our long-standing presence in Canada and enhances our diabetes management portfolio for regulated markets,” he said.
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The Canadian government confirmed the scale of the decision in direct terms.
“Today, Health Canada authorised a generic semaglutide injection. This is the first generic semaglutide authorised by Health Canada, and the first to be approved in the G7,” the department said in a statement on 29 April.
Health Canada described the review process in detail. It confirmed that Dr Reddy’s submission underwent a thorough evaluation of safety, efficacy and quality before receiving the green light. The department emphasised that differences between generic and brand-name versions do not affect how the drug performs in the body.
Health Canada added that it currently reviews eight other submissions from different companies. It expects to announce decisions on those in the coming weeks and months. The department also pointed out that generic drugs in Canada typically cost 45–90 percent less than brand-name versions, and that wider availability carries the potential for significant savings for patients and the healthcare system alike.
The active pharmaceutical ingredient in Dr Reddy’s Canada product comes entirely from its own manufacturing facilities in India. The finished product moves through its partner, OneSource Specialty Pharma Limited.
This detail matters. Health Canada’s approval now certifies that an Indian-made molecule meets one of the world’s most demanding regulatory standards.
For the broader Indian pharmaceutical industry, that certification carries weight far beyond a single product approval. It strengthens the case that India-origin complex generics can satisfy scrutiny from the most rigorous regulators on earth.
Dr Reddy’s had already launched its generic semaglutide in India under the brand Obeda after Novo Nordisk’s Indian patent expired on 20 March 2026. The Canadian approval validates what Indian regulators had already cleared, and takes it several steps further.
Moving faster than any other country in the world, multiple Indian companies launched DCGI-approved generics within 24 hours of the patent expiry. The speed reflected years of preparation by Indian manufacturers who had tracked the patent expiry closely.
Over 40 brands now compete in the Indian market. Monthly treatment costs range from ₹1,290 to ₹5,200 depending on the brand, dose and format. Novo Nordisk responded to the competition by cutting its own brand price to ₹5,660 per month. Generics remain significantly cheaper across the board.
Zydus Lifesciences entered with Semaglyn, priced from ₹2,200 per month. Alkem Laboratories launched Semasize at around ₹1,800. Glenmark brought GLIPIQ to market starting at ₹1,300. Natco Pharma and Eris Lifesciences both priced their versions at ₹1,290. Sun Pharma launched Noveltreat, starting at ₹3,000.
The generics treat type 2 diabetes across all brands. Select brands also carry approval for obesity management. Formats range from pre-filled disposable pens to reusable pens and multi-dose vials. Vials carry the lowest price points.
None of the generic semaglutide products currently feature on India’s National List of Essential Medicines. Patients pay entirely out of pocket, which limits reach among lower-income groups despite the dramatic price drop from the originator brand.
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Canada ranks as the world’s second-largest market for semaglutide, a fact that amplifies the significance of this approval. Around 3.9 million Canadians live with diagnosed diabetes, representing 9.7 percent of the population. Over six percent of adults carry prediabetes, a condition that significantly raises the risk of developing type 2 diabetes. The Public Health Agency of Canada expects both figures to rise as the population ages.
The entry of the first generic typically pulls prices to 75–85 percent of the brand-name drug. Once three or more competitors enter the market, prices tend to fall to around 35 percent of the originator’s cost. With Health Canada reviewing eight additional submissions and promising decisions within weeks, that competitive pressure builds fast.
Launch preparations at Dr Reddy’s are already underway. The company has not announced a specific launch date or price point for the Canadian market.
Core patents for Ozempic and Wegovy in the United States do not expire until the early 2030s. The American market, the world’s largest for semaglutide, remains firmly out of reach for generic manufacturers for now.
Apotex, a Canadian generics company, received tentative FDA approval on 10 April 2026. Tentative approval means the drug meets all safety and quality standards. It cannot enter the US market, however, until the ongoing patent disputes are resolved.
Compounded semaglutide had circulated widely across the US during the shortage period, offering patients an unofficial route to the drug at lower prices.
That route has tightened significantly. The FDA declared the semaglutide shortage resolved in early 2025. Compounded versions no longer hold legal standing as essential copies unless the patient carries a specific allergy to an inactive ingredient in the approved product.
The contrast with India and Canada grows sharper by the month. American patients continue to pay originator prices with no generic alternative on the horizon.
(Edited by Muhammed Fazil.)
