Canada and India now have generic Wegovy. Here's why the U.S. doesn't.

Dow Jones
05/22

MW Canada and India now have generic Wegovy. Here's why the U.S. doesn't.

By Tahir Amin

The U.S. allows drugmakers to extend their patent terms to prevent cheaper generic drugs from entering the market sooner. That's bad for patients.

Several countries will soon get generic versions of Wegovy and Ozempic, but that won't happen in the U.S. until at least 2032.

There are now highly anticipated generic versions of Novo Nordisk's GLP-1 blockbusters, Ozempic and Wegovy, on the Canadian market.

Several generic versions have also launched in India, with prices up to 80% lower than Novo Nordisk's pricing for the brand-name versions. Over the next year, countries that are home to 40% of the world's population, including Brazil, China, South Africa and Turkey, are set to get access to Ozempic and Wegovy generics that could cost as little as $15 a month.

The reason Canada and other countries are getting lower-cost generic versions is because the key patents protecting semaglutide - the active ingredient of the drugs - expired March 20. Meanwhile, patients, public payers and insurers in Europe and the U.S. have to wait until, at the earliest, 2031 and 2032, respectively, for generic versions of the game-changing GLP-1 medications that could significantly lower prices of these drugs. This is because patent policies in Europe and the U.S. extend the standard 20-year patent term by up to five additional years.

As a result of intense lobbying by the branded pharmaceutical industry, patent-term extensions were born in the U.S. in the early 1980s under what is now more commonly known as the Hatch-Waxman Act. The pharmaceutical industry argued that because of more stringent regulatory requirements introduced in 1962 to show the safety and efficacy of new products, the average effective patent life was cut to roughly 10 years instead of around 13 years. To compensate the industry for what it described as "regulatory delays," Hatch-Waxman's answer was to grant a maximum of five years of patent-term extension to guarantee up to 14 years of patent protection from the day a product is first approved. The concept was exported to Europe in the 1990s and to any other country that the industry - with the backing of successive U.S. governments - could successfully lobby.

When it comes to Novo Nordisk's (NVO) (DK:NOVO.B) semaglutide brands, which include Ozempic, Rybelsus and Wegovy, U.S. sales account for more than two-thirds of total revenue. The Initiative for Medicines, Access, and Knowledge, or I-MAK, the organization that I lead, last year released a report calculating how much the five-year patent-term extension in the U.S. could be worth to Novo Nordisk's semaglutide franchise. Given some of the recent price reductions in the U.S. for these products, we updated the calculation based on publicly available data and Novo Nordisk's own 2026 guidance.

We estimate that from March 2026 through December 2031, which is when the main compound patent for semaglutide expires in the U.S., Novo Nordisk could bring in approximately $146 billion in revenue. That works out to roughly an average of $80 million per day in the U.S. until the end of 2031. In comparison, if generic semaglutide became available this year, as it has in other countries, Novo Nordisk would still generate approximately $48 billion in revenue for its branded versions over the same period.

But in a pharmaceutical industry with financialized business models that put more weight on extracting maximum profit and increasing share value at the expense of patients, leaving $98 billion on the table would be seen as irresponsible. After all, the industry regularly reminds us that longer patent terms are needed to ensure they can make enough profit to pay for the research and development of the next wonder drug. Indeed, when lobbying for patent-term extensions back in the late 1970s and early 1980s, the industry argued that shortened patent protection due to regulatory requirements was causing a decline in profitability and stifling companies' ability to invest in R&D. Despite achieving the goal of longer patent monopolies, the evidence shows pharmaceutical companies are spending a large proportion of their profits on corporate shareholders through dividends and share buybacks.

A recent poll by the Kaiser Family Foundation found that about one in eight adults (12%) in the U.S. say they are taking a GLP-1 drug such as Ozempic or Eli Lilly's $(LLY)$ Zepbound. Among people who have not taken GLP-1 drugs, approximately one in five (22%) say they would be interested in doing so to lose weight. Yet among adults who have taken GLP-1 drugs, cost is one of the most commonly cited reasons for stopping - with 14% of such users saying they no longer use the medication for that reason.

Although it is largely operated by a foundation, Novo Nordisk is no different from the rest of the industry. Between 2018 and 2026, Novo Nordisk will generate an estimated $94 billion from U.S. sales of its semaglutide-based products. Based on disclosures in its annual reports, the company is expected to return $68 billion to its shareholders via share buybacks and dividends during that same period. That equates to 72 cents of every dollar not going to R&D but being extracted from payers and patients who are desperate for more affordable access.

With Lilly's GLP-1 Mounjaro surpassing Keytruda as the world's best-selling drug and its main patent not expiring until 2036, we can be sure that the CEOs of Novo Nordisk and Lilly will continue to look to the patent system to prolong their market monopoly and record-breaking revenues. In a financialized pharmaceutical industry, the ultimate marker of success and failure rests not with the lives improved or saved. It rests with the motivations and decisions of executives, investors and shareholders who continue to subscribe to a doctrine of short-term profits and revenue at the expense of our health and well-being.

It is well past time to end the statutory patent-term extensions that the industry has lobbied for over the past 40 years to prolong monopolies. We are often told by the pharmaceutical industry that Americans have a greater freedom of choice than other countries when it comes to the availability of new medicines. The story of semaglutide now being more available in other countries around the world raises the question: What good is that freedom if you cannot afford to pay for it? The $146 billion weight of five extra years of patent monopoly is not being carried by Novo Nordisk's shareholders. It's being carried by patients and payers.

Tahir Amin is a co-founder and CEO of I-MAK, a nonprofit working to lower the prices of prescription drugs by reforming the patent system. He and Rohit Malpani are the co-authors of the forthcoming book, "Pharma Monopoly: The Battle for the Future of Medicines."

-Tahir Amin

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(END) Dow Jones Newswires

May 21, 2026 12:16 ET (16:16 GMT)

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