On Jan. 5, Canada will be the first major market where cheaper generic versions of semaglutide – the active ingredient in Ozempic and Wegovy – become legal.Hollie Adams/Reuters
Indian pharma giant Dr. Reddy’s Laboratories Ltd. says Health Canada has rejected its application to make generic semaglutide, a setback for what was poised to be one of the first generic competitors to Ozempic to hit the market in 2026.
Ozempic, made by Danish drugmaker Novo Nordisk NVO-N, is easily the bestselling drug in Canada, earning more than $2.5-billion in sales at retail pharmacies last year, according to IQVIA Canada. It is prescribed to treat diabetes, while a higher-dose version called Wegovy is prescribed for weight loss.
Canada will be the first major market where cheaper generic versions of semaglutide – the active ingredient in Ozempic and Wegovy – become legal, starting on Jan. 5.
However, it’s not yet clear when those drugs will actually hit the market. Dr. Reddy’s had been the only major drugmaker suggesting it would be ready with product shortly after Canada’s legal protections lift.
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Erez Israeli, the drugmaker’s chief executive officer, said on an earnings call on July 23 that the company was prioritizing a launch in Canada in January, ahead of a launch in India when the semaglutide patent expires there in March. He cautioned that the timeline could be delayed pending regulatory approval.
On Wednesday, the company disclosed in regulatory filings that the initial response to its semaglutide submission from Health Canada had been negative.
“The [notice of non-compliance] outlines requests for additional information and clarifications on specific aspects of the submission,” company secretary K Randhir Singh wrote in a letter to shareholders. “We will submit a response at the earliest and well within the stipulated time period.”
Health Canada has been issuing more initial rejections of generic drug submissions in recent years, although ultimately approving most.
The Globe and Mail recently reported on data that showed 73 per cent of submissions were initially given a thumbs down in the 2024-25 fiscal year, although 90 per cent were eventually approved, sometimes months later. It has been part of what generic drug manufacturers say has been a slowdown in getting drugs to market in Canada.
Dr. Reddy’s did not respond to a question about whether it thought its rejection was part of the larger trend facing the industry.
Canadian firm enters race to bring generic Ozempic to market
More than one million Canadians are currently taking semaglutide injections, according to Novo Nordisk. The huge demand has led to a lot of interest from generic pharmaceutical companies.
Dr. Reddy’s was one of the first two companies to put in a submission to Health Canada to make generic semaglutide, in either February or March of 2024. (Health Canada’s registry of generic drug submissions does not list company names before April, 2024.)
Since then, five more companies have made submissions: Sandoz Canada Inc., Apotex Inc., Taro Pharmaceuticals Inc., Aspen Pharmacare Canada Inc. and Teva Canada Ltd. None have disclosed responses to those submissions yet. As well, a new Canadian pharmaceutical company called Vimy Pharma, founded by two former Novo Nordisk Canada executives, has said it plans to launch a generic semaglutide, too.
Sandoz chief executive officer Richard Saynor said in a call with analysts Aug. 7 that the company plans to launch “at some point during 2026, but we’ll see when we get there.”
The price of generic semaglutide will depend on how many competitors are on the market.
Generic drug prices are set out in an agreement between a national body called the pan-Canadian Pharmaceutical Alliance and the industry group Canadian Generic Pharmaceutical Association. If there is one generic product, the price is set at 85 per cent of the brand price; two leads to a discount of 50 per cent off the brand; and three or more sets the price at 35 per cent for injectables.
The current list price of Ozempic in Canada is $223 for a four-week dose, before markups from pharmacies and wholesalers.