As Novo’s patent expires, GLP-1 generics go global

We know GLP-1s are all the rage in the US, with 1 in 8 adults already taking the medications, according to KFF.

But the US isn’t the only country interested in treating diabetes and obesity. Worldwide, there’s an estimated 830 million people living with diabetes and 1 billion people living with obesity. Morgan Stanley Research reported that the global GLP-1 market could reach $190 billion by 2035, with China and Brazil in particular seeing possible “rapid expansion” in uptake.

Novo Nordisk’s patent on semaglutide expired in several large countries in March, clearing the way for cheaper generic alternatives that could make GLP-1s attainable for many more people globally. Canada’s FDA equivalent, Health Canada, has already approved two generic versions of Ozempic and is reviewing submissions for seven others, according to a May 1 press release.

In other words, GLP-1s are ready to go global.

Worldwide Wegovy

Novo is already selling its GLP-1s, which include Ozempic and Wegovy, in 80 countries, Rodrigo Gribble, the company’s SVP of obesity, told us. “The interest in GLP-1s is growing across the globe,” he said, which translates to 14 million patients.

Part of that growth is coming from new pill medications—in Novo’s case, Wegovy—compared to just injectables. Eli Lilly also has an oral option, Foundayo (orforglipron), as of April 1. Lilly did not respond to requests for an interview, but is reportedly working to expand into 40 countries.

Some people “really reject needles” and are more comfortable with pills, Gribble said.

According to Novo’s Q1 earnings, Wegovy saw a boost from the new pill. EVP of US Operations Jamey Millar said during the call that 1 million people are already using the Wegovy pill, “far outpacing the uptake of any prior GLP-1 drug launch in the US.” Meanwhile, 20,000 people are already taking Lilly’s Foundayo, CNBC reported.

Long term, Gribble said, the US is a priority but “it’s important for us to ensure that we work to bring our medicines beyond the US.”

Patent pending

While Novo’s international patent has expired in several countries, it gets to hold on to its US-based semaglutide patent until 2032. And many of Eli Lilly’s US patents for tirzepatide (Zepbound and Mounjaro) don’t start to expire until 2036.

That’s simply due to differences in how countries write their patent language, Jayne Hornung, chief clinical officer at pharma consultancy MMIT, told Healthcare Brew. And although Novo has a US patent for several more years, “the international market is probably where they need to be concerned,” Hornung said.

The countries in which Novo’s patents have expired represent 33% of the global population of adults with obesity, according to life sciences research and analytics firm IQVIA.

“The product going generic internationally is probably going to play a significant role in the US market as well because people will start going internationally to get the generic version,” Hornung added. (When AbbVie lost its Humira patent in 2023, for example, global sales plummeted 34% from $3.5 billion in Q1 2023 to $2.3 billion in Q1 2024).

Lilly and Novo are both going to feel pricing pressure as a result and won’t be able to come to the market with prices as high as they currently are, Hornung said. Both Ozempic and Zepbound can cost more than $1,000 per month.

“Price is important to patients, and if they can get something for $14 a month that they were getting previously for, in some cases, $900 or $1,000 a month through employer plans, where are you going to go?” Hornung said.

Lilly and Novo will both likely be forced to reduce their prices, she added.

However, Emil Kongshøj Larsen, Novo’s EVP of international operations, said in a May 6 earnings call that the introduction of the first two generics in Canada is expected to have just a low “single-digit impact” on the company’s earnings.

Patrik Jonsson, EVP of Eli Lilly and president of Lilly International, said in an April 30 earnings call that while the company only has a few weeks’ worth of data from India on how generic semaglutide is impacting the market, it seems the generics are “really stimulating the growth in the overall obesity market, and that includes [Mounjaro].” Prescriptions for Mounjaro have been 10% higher in recent weeks compared to before generic semaglutide was introduced, he added.

Bigger pie = lower prices

In general, GLP-1s sell similarly to other drugs in the international market—which is to say, it’s quite different from how the US operates, Philip Sclafani, who leads consultancy PwC’s pharmaceutical and life sciences commercial practice, told Healthcare Brew.

Where the US market is a multipayer system with Medicare, Medicaid, and commercial coverage, a number of international markets have single-payer systems. These markets are similar in that if prices are coming down, there’s more insurance coverage and more direct-to-patient options, he said.

“But it’s not surprising to see this kind of evolution where the US market pays more for something first and then [other international] markets start to pick it up,” Sclafani added.

He’s expecting China, India, Brazil, Canada, and Turkey to attract the most GLP-1 attention as large countries with higher populations of adults with obesity, though he said there’s still a question of which medication will scale the best around the world.

“Some of the brands may be able to lower their prices and keep some brand loyalty and get that volume,” he said. 

Gribble seemed confident that Novo’s reputation will stand out abroad, calling the company “pioneers” in the weight loss space.

At the end of the day, Sclafani said companies “don’t have to be successful everywhere,” but can focus their efforts on countries where interest is growing.

“It’s less about who gets the share now and more about how big can the treated population and pie grow,” he said, like through generics or compounders. “The hope for the branded companies is they’ll launch these newer, better agents and be able to capture a growing slice of that now really big pie.”