Kenneth Glad
One of the world’s most successful diabetes medicines is beginning to face generic competition in parts of the global market. The shift follows changes in patent protection and could influence how quickly rival drugmakers move into the booming semaglutide sector.
Health Canada has approved a generic semaglutide injection from Dr. Reddy’s Laboratories, equivalent to Ozempic, marking the first authorization of its kind in a G7 country.
The decision allows a competing version of the type 2 diabetes treatment to enter a market where Ozempic generated billions in sales last year, writes Drug Discovery Trends.
The publication reports that more than one million Canadians currently use Ozempic, which has become one of Novo Nordisk’s most commercially important medicines.
Semaglutide, the drug’s active ingredient, is also used in the obesity treatment Wegovy.
The Canadian approval followed the lapse of a Novo Nordisk patent connected to semaglutide compounds. Drug Discovery Trends says that the patent expired after a required maintenance fee was not paid, ending legal protection earlier than in several other large pharmaceutical markets.
Health Canada said the approved product met the agency’s standards for safety, quality, and effectiveness. Regulators also stated that additional semaglutide submissions remain under review.
Expanding generic market
The approval reflects growing international interest in generic versions of GLP-1 medicines, a category that has transformed the diabetes and obesity treatment business over the past several years.
According to Danish newspaper JydskeVestkysten, semaglutide generics have already launched in India, where patent protection has also expired.
Additional versions are expected in countries such as China, Brazil, Turkey, and South Africa.
“As GLP-1 therapies continue to be a key focus area for us, we are actively working to
expand access across multiple global markets,” Dr. Reddy’s chief executive Erez Israeli said in a company press release.
The company also said the approval highlighted its experience in peptide development and complex injectable medicines.
Health Canada authorized pen presentations containing 2 mg and 4 mg doses at a concentration of 1.34 mg/mL.
Pressure on Novo
Novo Nordisk still maintains longer patent protection in several major markets, including the United States.
Drug Discovery Trends writes that the company lists U.S. patent expiry for Ozempic, Wegovy, and Rybelsus in 2032.
The Danish drugmaker has also faced rising pressure tied to soaring demand for GLP-1 medicines.
In the United States, semaglutide products experienced supply shortages beginning in 2022, leading some compounding pharmacies to produce alternative versions while supplies remained limited.
Novo Nordisk recently adjusted its financial outlook. According to JydskeVestkysten, the company narrowed its full-year adjusted sales guidance to a decline of 4% to 12% at constant exchange rate s, compared with an earlier expectation of a 5% to 13% decline.
The company also said that patent expirations in some countries during 2026 are expected to affect international sales.
Market changes ahead
Semaglutide has become one of the pharmaceutical industry’s most valuable products, helping fuel explosive growth in the global GLP-1 market.
Ozempic, Wegovy, and related medicines reshaped treatment demand for diabetes and weight management while generating billions in annual revenue for Novo Nordisk.
The arrival of generic competition in one regulated market does not automatically guarantee lower pharmacy prices or rapid global expansion.
Patent timelines, national regulations, and manufacturing capacity will continue to shape how quickly competitors can enter different countries.
Still, the latest approval marks a significant step in the transition of semaglutide from an exclusively branded medicine toward broader generic competition.
Sources: Health Canada, Drug Discovery Trends, JydskeVestkysten, Dr. Reddy’s Laboratories.
