Cheaper generic Ozempic is coming to Canada after Novo Nordisk fails to maintain patent in this country

In what Science magazine has dubbed “Novo Nordisk’s Canadian Mistake,” Ozempic is soon to come off patent in Canada, opening the door to cheaper generic copycats, after the drug giant reportedly failed to pay a few hundred dollars in annual fees to maintain the patent rights before the weight-loss drug became a blockbuster seller. As Science reported, a patent, once lapsed, can’t be restored. Novo Nordisk will continue to hold its U.S. patent until 2032. Ozempic was already the third most prescribed drug in Canada last year with 7,390,000 prescriptions dispensed, a 17 per cent increase over 2023, according to drug analytics research firm IQVIA. Several applications for generic semaglutide, the active compound in Novo Nordisk’s injectable drugs Ozempic and Wegovy, are now before Health Canada. Last week, a U.S. telehealth service announced plans to expand into Canada next year and offer generic semaglutide at  a significant discount. Richard Saynor, the head of Sandoz, a global leader in generic and biosimilar drugs, told Endpoint News in June that his company has filed for approval for a generic semaglutide in Canada once Novo Nordisk’s patent exclusivity expires “sometime in Q1 next year.” Canada is the globe’s second-biggest semaglutide market, Saynor told Endpoint News. “You gotta ask why. I don’t think Canadians are disproportionately large. There’s clearly a dynamic, like insulin, with cross-border business,” he said. Americans with diabetes have crossed into Canada to buy insulin at much lower prices. Ozempic and Wegovy cost about $5,000 per year. If money is no longer a factor, if chemically-identical drugs are cheaper and more affordable, “that’s going to change the calculus for many people,” said Justin Lehmiller, a senior research fellow at Indiana University’s Kinsey Institute and co-author of a new survey exploring the impact that weight-loss drugs — formally known as GLP-1 agonists — are having on dating and intimacy. The survey of 2,000 single Americans (aged 18 to 91) led by Kinsey with DatingNews.com found eight per cent reported having used a GLP-1 medication for weight loss in the past year. Among the GLP-1 users, 16 per cent said exes had reached out to reconnect, 14 per cent said they were getting more matches on dating apps and 12 per cent said they were going on more dates. The drugs seemed to be doing more to booster “online dating success” for men than for women, the researchers said. “Some of the studies and research that I’ve seen suggest that men only match one in 100 times on dating apps where for women, it’s more like one in 10,” Lehmiller said. “An attractiveness boost for men, which often accompanies using these drugs, could translate into a much bigger impact for them in the world of dating.” Men, however, were nearly twice as likely to women to say they feared being judged or shamed for taking Ozempic or other GLP-1 drugs. “There are some masculinity concerns that are tied up in this,” said Lehmiller, a social psychologist. Men might worry about being accused of cheating, he said. “It might be viewed as a sign of weakness for turning to a drug as opposed to losing weight through ‘hard work.'” About half of the GLP-1 users also said the medications impact their sex lives, in both positive and negative ways: 18 per cent said their sexual desire increased, while 16 per cent said it dropped. Sixteen per cent said their sexual function improved; 12 per cent said it worsened. It’s a nuanced picture, Lehmiller said. “These drugs seem to be affecting different people in different ways.” “And I think that makes sense: There is a lot of variability in the side effects people experience on these drugs.” More side effects might mean more negative impact on intimacy, he said. The drugs have also been associated with a slightly higher risk o f erectile dysfunction and testosterone deficiency in men taking semaglutide for obesity compared to men not taking the drug. About one in five in the dating survey said the drugs are creating more stigma against being overweight. “Changing standards of attractiveness might be creating more pressure for people to look a certain way or use these medications,” Lehmiller said. A study published this week in the Canadian Medical Association Journal found 32.7 per cent of adults in Canada (10.6 million people) were obese in 2023, an eight per cent jump over 2009. Generic semaglutide won’t be as cheap as Aspirin. “It’s still going to be a cost,” said Dr. Hertzel Gerstein, an endocrinologist and professor in McMaster University’s department of medicine. “And that does not relieve a responsible health practitioner of assessing a patient before they prescribe the medication,” he said. “Is it possible that more people would be willing to pay out of pocket if they don’t have insurance coverage for the drug? Sure, if it’s cheaper,” Gerstein said. “There may be more demand for it. People need to understand the risks and benefits.” Taken once a week by injection, Ozempic and Wegovy work by mimicking a hormone — glucagon-like peptide-1 — the small intestine releases when people eat. GLP-1 tricks the body into thinking it’s full. It works on the brain to reduce appetite and interest in continuing to eat, and works on the stomach to slow how fast it empties so that food lingers in the stomach longer. Semaglutide has been studied extensively, Gerstein said. The amount of weight lost is related to the dosage: the higher the dose, the more weight dropped. In people with type 2 diabetes, the drug can reduce the need for insulin, or the dosage. “But most importantly these drugs unequivocally reduce the future risk of serious health outcomes, including heart attacks, strokes, death from cardiovascular causes” and heart failure symptoms when used long-term, “in the two- to five-year window of time,” Gerstein said. A major analysis published earlier this year based on health data from more than two million Americans veterans with diabetes found that, compared to more traditional drugs, GLP-1 use was associated with a reduced risk of substance use (alcohol, cannabis, stimulants and opioids), psychotic disorders such as schizophrenia, seizures, several respiratory conditions and neurocognitive diseases like Alzheimer’s and dementia. The magnitude of the associated benefits — about a 10 to 20 per cent reduction for most outcomes — was modest, according to a background release, though the researchers said they don’t “negate” the potential value of the drugs. There were, however, several drawbacks, including an increased risk of gastrointestinal disorders (nausea, vomiting, diarrhea), low blood pressure, fainting, arthritic disorders, kidney disorders and drug-induced pancreatitis associated with GLP-1 drugs compared to usual care. Nothing is guaranteed, Gerstein said. “I always tell patients we don’t know exactly what it’ll do in you. And weight loss, if it’s going to happen, usually takes a month or two to start” and plateaus at around eight months. People don’t lose weight indefinitely. “There’s definitely a plateau. You do not keep losing weight,” he said. The drugs yield an average weight loss of around 15 per cent, and weight can also rebound rapidly once the drugs are stopped. Ozempic has been approved in Canada for diabetes but is often used “off label” for obesity. Wegovy has been approved for obesity. In an email to National Post, Novo Nordisk, the only current company in Canada with Health Canada-approved products containing semaglutide, said “all intellectual property decisions are carefully considered at a global level. “Periods of exclusivity for pharmaceutical products end as part of their normal lifecycle and generic treatments may become available over time.” “Currently, no Health Canada-approved generic versions of semaglutide exist and we cannot speculate on other manufacturers’ plans,” the company said. National Post         Our website is the place for the latest breaking news, exclusive scoops, longreads and provocative commentary. Please bookmark nationalpost.com and sign up for our newsletters here.