Novo Nordisk is on the verge of losing patent protection for its blockbuster weight loss drug in India, China and several other nations, opening the door for cheaper competing versions, reports The New York Times.
This past weekend, the drug, sold as Ozempic and Wegovy, went generic in countries that are home to 40% of the world’s population, significantly lowering the price of a costly medicine that had been largely unaffordable to nearly all but the wealthiest people.
The first generic versions are expected to arrive in India as soon as this week, and in the coming months, the generics are also expected to become available in South Africa, China, Canada, Brazil and Turkey.
“The availability of these drugs, which have been restricted to high-income countries to very wealthy people, will now be democratised by the generics,” said Leena Menghaney, an activist in New Delhi focused on treatment access.
The new markets for generics are enormous. Together, India and China are home to more than 800m adults who are obese or overweight and more than 360m adults with diabetes.
The generics are poised to shake up a global market for drugs that have transformed the treatment of obesity. Novo Nordisk and competitor Eli Lilly have generated huge sales worldwide, but access has been very limited.
Generics promise to significantly increase the number of people taking the drugs, which have also been shown to help prevent heart attacks and strokes.
In the United States and Europe, the drug is not expected to go generic until the early 2030s. That delay is due to special regulatory protections that are intended to encourage innovation by extending a brand-name drugmaker’s monopoly.
Dozens of generic manufacturers have been racing to produce supplies and win regulatory approvals in countries where they can soon compete. Huge demand is expected from patients who could not afford Novo Nordisk’s offering but can budget for cheaper generics.
Novo Nordisk sells the drug, semaglutide, as Ozempic for diabetes and as Wegovy for obesity.
“I don’t think there has ever been so much excitement for any class of drug going off patent,” said Siddharth Mittal, chief executive of Biocon, a manufacturer in India that hopes to introduce generics next year in Brazil, Canada and Turkey.
Generic makers have not yet disclosed pricing plans. Analysts predicted that as more competitors enter the market, prices for the generics could eventually drop to about $15 a month. By comparison, higher doses of Wegovy can be bought in the United States without insurance for $349 a month.
(The drug is generally available at five dose levels. Higher doses are more expensive. Patients typically start at a low dose and move up to higher doses over a matter of months.)
The drugs are not a cure-all. Some patients stop taking them because of side effects, like nausea, vomiting and constipation, but adverse reactions that have been reported are rarely severe.
Public health advocates hope that if competition from generics drives down prices enough, national health insurance systems might agree to cover the drug for their citizens. Some public health systems, mostly in rich countries, pay for its use to treat diabetes, and all reject coverage for most people taking it to lose weight, because of the cost.
More competition for Novo
The expiration of the patents presents more trouble for Novo Nordisk, whose stock has plummeted as global competition has eroded its market share. At its peak in mid-2024, the Danish drugmaker was the most valuable public company in Europe.
America’s Eli Lilly, which sells its weight loss drug as Mounjaro for diabetes and as Zepbound for obesity, poses the biggest competitive threat. Eli Lilly is expected to retain patent protection for another decade in most major markets.
Last year, the United States accounted for two-thirds of Novo Nordisk’s global sales of Ozempic and Wegovy. But the company has lost US market share to cheap copycat versions of the drug produced through the compounding process.
These are not generics; they fall into a legal grey area, and US regulators recently vowed to restrict their sales.
Seeking to preserve its monopoly, Novo Nordisk has fought in courts in India, China and Brazil to try to block the generics. The company has also cut prices in China and India in anticipation of competition.
Officials at Novo Nordisk said the company had developed several strategies to keep reaching patients in countries where it will soon face generics. It might sometimes try to position the original version as a premium brand, they said.
Researchers estimated that the generics could be mass-produced for as little as $3 a month per patient.
In India, Novo Nordisk sells higher doses of Wegovy for about $180 a month, a price that is out of reach for most patients.
“Many of my patients would benefit from them, but haven’t been using them because of their cost,” said Dr Reema Arora, a dermatologist and cosmetologist in New Delhi.
Alkem Laboratories of Mumbai, one of several manufacturers that has won regulatory approval to market a generic in India, has been producing supplies and preparing to distribute them. “We will try to ensure as quickly as possible that we can make our product accessible to doctors and patients,” said Vikas Gupta, the company’s chief executive.
India, like many countries, does not permit the kind of prescription drug ads aimed at consumers that are omnipresent in the United States. But with generics looming, Novo Nordisk this month paid for a front-page ad promoting obesity awareness in The Times of India.
Eli Lilly has been running ads featuring Bollywood actors. Apparently in response, Indian regulators last week warned the makers of weight loss medicines about the rules against drug advertising.
Booming in China
By early March, 10 generic competitors were in the final stage of being evaluated by Chinese regulators to sell their semaglutide products, and at least a dozen more firms had completed clinical trials.
The United Laboratories, which has its headquarters in the southeastern province of Guangdong and in Hong Kong, expects approval to sell its generic for diabetes before July, said Cao Chunlai, an executive at the company’s R&D subsidiary.
China’s national health insurance system covers Novo Nordisk’s drug for diabetes, while people taking it for obesity must pay out of pocket.
Novo Nordisk makes all of its global supply in-house.
But more than a dozen Chinese manufacturers have already been making active ingredients for semaglutide that is sold in markets around the world, including compounded versions for American consumers.
Long wait for Americans
Why are Americans and Europeans getting semaglutide generics so much later? The reason can be boiled down to a critical difference in how friendly countries are to the pharmaceutical industry.
Patents are good for 20 years after an application is filed. But because Novo Nordisk spent years developing its drug and waiting for regulatory review, the company has been selling it for only about eight years.
For situations like this, the United States and Europe grant brand-name drugmakers like Novo Nordisk special protections – patent term extensions – giving them a monopoly for a few more years.
These protections date back to the 1980s and 1990s, when drugmakers intensely lobbied American and European lawmakers, arguing that a shorter monopoly span would discourage investment in new medicines. Such protections do not exist in India.
“These policies are essentially subsidies for the pharmaceutical industry, at huge expense for American and European patients and taxpayers,” said Tahir Amin, chief executive of the Initiative for Medicines, Access & Knowledge, or I-MAK, a non-profit that tracks drug patents.
US prices for Wegovy have fallen in recent months, partly because of a deal Novo Nordisk struck with the Trump administration in exchange for relief from the President’s threatened tariffs. But that deal did not cut prices as deeply as generic competition would have.
Because of the delay, millions of Americans who could have benefited, probably won’t have access to the drug. Meanwhile, spending on Novo Nordisk’s version of the drug will be inflated by tens of billions of dollars, I-MAK estimated.
See more from MedicalBrief archives:
Aspen sets its sights on Canada for generic weight-loss jabs
Cheaper obesity drugs in Indian and Chinese pipelines
Costly Ozempic can be made for less than $5 month – UK study