Weight-Loss Blockbuster Ozempic and Wegovy Set
to Go Generic in India as Novo Nordisk Goes Off Patent, No Off Patent in US and
Europe
In India, China and several other nations,
Novo Nordisk is on the verge of losing patent protection for its blockbuster weight
loss drug, opening the door for cheaper competing versions.
1.
The blockbuster weight-loss and diabetes drugs
Ozempic and Wegovy are set to lose patent protection
in several major countries, including India.
2.
Danish drugmaker Novo Nordisk will face generic
competition in countries that together account for nearly 40% of the world’s
population.
3.
The first generic versions are expected to launch
in India immediately, followed by China, Brazil, Canada, Turkey and South
Africa.
4.
Cheaper generics are expected to significantly reduce
the cost of semaglutide-based treatment, which has so far remained
unaffordable for most patients.
5.
India and China together have hundreds of
millions of overweight, obese and diabetic adults, making them the biggest
potential markets for the generic versions.
6.
The development is likely to intensify competition
in the global weight-loss drug market, especially for Novo Nordisk and its key
rival Eli Lilly.
7.
While generics will become available soon in
emerging markets, the drugs are not expected to go generic in the United
States and Europe until the early 2030s due to extended patent protections.
The
blockbuster weight loss drug sold as Ozempic and Wegovy
will soon go generic in countries that are home to 40 percent 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.
On
Saturday, Novo Nordisk, the company that until now has had a monopoly on selling
the drug, will lose patent protection in several of the world’s most populous countries.
The first generic versions are expected to arrive in India as soon as this weekend.
In the coming months, the generics are also expected to become available in China,
Canada, Brazil, Turkey and South Africa.
“The
availability of these drugs, which have been restricted to high-income countries
to very wealthy people, will now be democratized 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 800 million adults who are obese or overweight and more than 360 million 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 its competitor, Eli Lilly, have generated
huge sales around the world, 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.
Argent
Wang, 31, who lives in the northeastern Chinese city of Dalian, said she spends
about $160 a month for the drug. She stopped working to manage complications from
diabetes and lives at home with her mother, who also has diabetes. Ms. Wang’s doctor
suggested that she switch to a different dose, but at $291 a month, she cannot afford
it.
If
a Chinese company offered a generic that was just as effective and cost under $75
a month, Ms. Wang might try it. “My expenses are so large, I will consider the path
that saves money,” she said.
More competition for Novo Nordisk
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.
Eli
Lilly, an American company that 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 U.S. market
share to cheap copycat versions of the drug produced through a process known as
compounding. These are not generics; they fall into a legal gray
area, and U.S. 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.
Once
the generics arrive in Canada, where Novo Nordisk’s patent protection expired in
January, some U.S. patients might seek to import the drug from Canadian pharmacies.
Generic
makers could also bring semaglutide to poorer countries where Novo Nordisk never
sought patent protection and where there has been very little use of the drug so
far. Researchers estimated that the generics could be mass-produced for as little
as $3 a month per patient.
Anticipating lower prices in
India
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 and make sure as quickly
as possible that we can make our product accessible to doctors and patients,” Vikas
Gupta, the company’s chief executive, said.
On
Instagram and WhatsApp, Indian patients have been eagerly discussing the arrival
of the generics, said Himani Raj, who lives in Ahmedabad, in western India. She
takes Eli Lilly’s drug and runs one of the discussions.
In
New Delhi, Dr. Nivedita Dadu, a dermatologist, said she expects patient demand for
the drugs to grow once cheaper generics become available. Already, she and her sister,
an anesthesiologist, have been prescribing the brand-name
drugs to hundreds of patients.
One,
a 55-year-old man, lost enough weight that he was able to fit back into a beloved
pair of jeans from 25 years ago, she said. “When he finally came to the clinic in
those jeans, he got so emotional,” she said.
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, a major newspaper. 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.
Drug production booms 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 research and development 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.
Lei
Zhang, 33, a tech worker in the southern Chinese city of Suzhou, used to spend about
$200 a month for Eli Lilly’s Mounjaro to manage his diabetes.
But in August 2024, he switched to Ozempic, which is cheaper, reducing his out-of-pocket
cost to just $16 a month.
Mr.
Zhang said he’s optimistic about switching to a Chinese generic. Since so much semaglutide
is already made in China, “there shouldn’t be much difference,” he said.
A 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, called 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 nonprofit that
tracks drug patents.
U.S.
prices for Wegovy have fallen in recent months, in part
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 most likely 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.