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There are two clear market leaders in the market for obesity drugs. Novo Nordisk and Eli Lilly are the only pharmaceutical companies with GLP-1 medications approved for weight loss, and the popularity of their drugs has made them household names.
Since GLP-1s hit the market, the five biggest diabetes and obesity medications — Novo’s Ozempic, Wegovy and Rybelsus, and Lilly’s Zepbound and Mounjaro — have collectively raked in $71 billion in U.S. revenue since 2018, according to a recent report by the Initiative for Medicines, Access and Knowledge (I-MAK), a nonprofit focused on documenting what it sees as abuses in the patent system. Ozempic, which also has approvals in chronic kidney disease and heart disease, accounted for about half of that total.
There’s more growth to come. By 2030, cumulative revenue of those five GLP-1 drugs are projected to reach $470 billion, I-MAK estimated, which would make them some of the best-selling products of all time, according to Tahir Amin, CEO and co-founder of I-MAK.
“What's pretty staggering is how much these drugs are going to earn in their first five years compared to some of the best-selling drugs we've seen over the last two decades,” Amin said.
Zepbound, which was approved by the FDA for weight loss in 2023, will earn $66 billion in revenue during its first five years, I-MAK projected, using consensus estimates from Wall Street. That estimate dwarfs the revenues earned by other bestsellers “once considered industry-shaping,” such as Prozac and Viagra, which pulled in $4 billion and $7 billion, respectively, in their first five years on the market. Keytruda, Merck & Co.’s blockbuster cancer drug — and the industry’s top seller in 2024 — took home $14 billion during that same amount of time.
GLP-1 drugs are now in a league of their own, and even as competition creeps closer to market, Novo and Lilly’s are working to ensure they’ll stay at the top.
A patent playbook
To help maintain market dominance, Novo and Lilly are taking a page from the pharma playbook for creating patent thickets. Novo, in particular, is taking these protections to new heights.
The Danish pharma company has filed 320 patent applications for its three semaglutide drugs and has been granted 154, according to I-MAK. Its main patent for semaglutide is set to expire at the end of 2031 because of a five-year extension through a Patent Term Adjustment and a Patent Term Extension, according to I-MAK. During this extended five-year period, Novo could bring in another $166 billion in revenue from Ozempic, Wegovy and Rybelsus.
Novo has also been granted another 49 patents that cover minor modifications to the products and offer exclusivity protections through 2042.
This strategy is a common way to limit the potential for generic competition. However, the high number of Novo’s patent applications is more typical among biologic monoclonal antibodies, than Novo and Lilly's polypeptides.
“In the biologic space, it's quite common to see hundreds of patents,” Amin said. “To have 320 patent applications, they're putting themselves in the same bracket as biologics. And these drugs are not as complex as those.”
By comparison, Lilly has only applied for 53 patent applications and been granted 16 for its two tirzepatide drugs Zepbound and Mounjaro, with the main compound patent set to expire in 2036. Add-on patents have extended the protections through 2041, although Lilly could still apply for more patents that could further lengthen tirzepatide’s exclusivity, according to I-MAK.
“Eli Lilly is still in its early days [with tirzepatide],” Amin said. “The underlying drug is still a more recent approval, whereas Ozempic has a longer history runway. I think we'll see Eli Lilly build [those patents] up over time.”
These patent strategies have made it unclear exactly when generic semaglutide and tirzepatide could pose a threat. A generic version of liraglutide, a GLP-1 medication for diabetes under Novo’s brand name of Victoza, was launched last year by Teva Pharmaceuticals after the pharma company reached a settlement agreement with Novo. Generic drugmakers could also come after Novo and win rights to launch generic semaglutide sooner than the date its patent extensions lapse.
But as GLP-1s gain more approvals for new disease areas, Novo and Lilly will push their patents further. For example, Novo is studying semaglutide in addiction, osteoarthritis and MASH.
“These drugs are going to be perpetually novel because they’ll keep re-pattenting [them] for a different use,” Amin said. “There'll always be a monopoly on the drug, even if other uses drop off and become generic.”
New entrant influence
Novo and Lilly could also face competition from novel cardometabolic drugs, though. Dozens of pharmas are developing obesity treatments and, while some are experimenting with GLP-1 combinations and oral versions, others are working on completely new drugs.
Even as these other companies threaten to elbow their way into the market, will any of these novel approaches make a dent in Novo and Lilly’s armor?
“As it stands now, Eli Lilly and Novo Nordisk [have] got the GLP-1 space locked down,” Amin said.
Drugmakers could potentially compete with a better price. Lilly’s and Novo’s GLP-1 self-injectable drugs are currently listed at around $1,000 per month, although both have recently begun offering vials for a lower, out-of-pocket monthly cost.
But until generics or new obesity drugs land on the market, Novo and Lilly aren’t likely to lower prices much more. There’s no competitive incentive to do so, and in fact, they may even raise prices in the run-up to their patent expirations, according to Amin.
“We might see the price go up … while they've still got these, pattern monopolies,” he said.
Other drugmakers are also developing formulations that could give them an edge in the obesity market and companies like Roche are spending billions on new hopefuls. The hunt for an oral versions in particular is being closely watched, with companies such as Viking Therapeutics and Pfizer moving candidates through the clinic.
But the market leaders are also working to compete with these rising contenders as well. Novo’s oral semaglutide Rybelsus is approved for Type 2 diabetes and being tested for other indications. And last week, Lilly announced topline phase 3 results from a trial of its GLP-1 pill orforglipron, which showed that the drug controlled blood sugar and resulted in weight loss on par with the injectable versions.
Still, Novo and Lilly’s stronghold on the market and patient familiarity with their products have given them a leg up on any emerging competition for years to come. Their revenue has also put GLP-1s on track to become the best-selling drugs of all time.
“Unless there's some massive [user] drop-off because of some health reason, [GLP-1s are] going to take the pharmaceutical industry to a new stratosphere,” Amin said.
