Ozempic, a patent challenge, and the $25 billion race for India's weight-loss drug market

Mint

5 hours ago

Mumbai: In late May, Dr. Reddy's Laboratories, a pharmaceutical company from Hyderabad, sprang a surprise. It filed a patent challenge against Novo Nordisk, a Danish company, for its popular weight loss drug semaglutide.
Novo Nordisk filed for two patent applications in India—in 2006, which expired in September 2024, and another in 2007, which is set to expire in March 2026. Dr. Reddy's has challenged the second patent, contending that it lacks novelty.
Pharma companies often file follow-on patents with claims of modifications to the original compound and its derivative forms. The follow-on patents allow drug developers to extend their market monopoly and halt generic competition for longer. Generic versions are cheaper copies of the original drug.
Dr. Reddy's, obviously, is in a hurry to launch a generic version. A win for the company will upend the plans of more than a dozen local pharmaceutical firms, all of whom are eyeing a slice of the estimated $25 billion Indian weight loss market.
No prescription drug in recent memory has captured the imagination of Indian patients as much as semaglutide. Or for that matter globally. In 2024, sold under three brand names—Ozempic, Wegovy and Rybelsus—semaglutide is the second most prescribed drug in the world, notching sales of $29 billion annually.
A more recently launched competing brand, Mounjaro, by US-headquartered drug maker Eli Lilly, grew 123% in 2024 to $11.5 billion and is already among the top 10 drugs in the world, according to Drug Discovery & Development, a pharmaceutical industry news website.
'It's a big opportunity. It's a product that comes once in a while in the pharma cycle, and perhaps a product that people are a lot more aware of, much before its launch," Umang Vohra, managing director and global CEO of Cipla, told journalists during an interaction last month.
Social media has contributed immensely to the street popularity of Ozempic, largely driven by celebrity endorsements by the likes of Oprah Winfrey and Elon Musk. Both admitted to using such drugs to manage their weight. Though Indian celebrities haven't yet admitted to their use, the mystery slimming of Bollywood film maker Karan Johar and TV talk show host Kapil Sharma have drawn comparisons.
Opportunity 2.0
Nonetheless, it is not all social media. There is a genuine market for weight loss medications—numbers tell the story.
A recent Lancet study stated that India is expected to total 450 million overweight or obese people by 2050, the largest in the world. The study also found that obesity rates increased from 1.2% in 1990 to 9.8% in 2022 for women and 0.5% to 5.4% in men. Those with body mass index (BMI) between 25 kg/m2 to 29.9 kg/m2 are considered overweight while those with an index of over 30 kg/m2 are considered obese.
'Often, lifestyle diseases are associated with adults but we must not overlook the increasing issues of overweight and obesity in juveniles. It is a growing menace," said Dr Sambit Patnaik, a Mumbai-based surgeon.
The pharmaceutical industry has also spotted a rare opportunity, similar to the one it saw in anti-diabetic drugs at the turn of the century. At that time, the Indian pharmaceutical market, according to market research agency MARG, was all of ₹16,000 crore and diabetic drugs accounted for about ₹1,000 crore of it. Today, the market for diabetic drugs is worth ₹40,000 crore and it accounts for roughly 10% of the ₹4 trillion Indian industry.
Back then, the boom was aided by the generic version of metformin, an oral drug with lower gastric side effects for type 2 diabetes. It caught the fancy of Ranbaxy Laboratories, Dr. Reddy's, Glenmark Pharmaceuticals and a host of other Indian pharmaceutical companies.
Like diabetes drugs, weight loss medications also have to be taken as long as a patient wants to manage her or his weight—which explains the current gold rush.
Crash the price
In India, generic versions can cut current prices substantially, thereby expanding the market.
Novo Nordisk's Rybelsus is available in India but only in oral form and a month's supply costs ₹10,000. The most effective form of the drug is as an injectable, and it is delivered in metered doses using a pen-like device with thin hair like needles. Imports can cost upwards of ₹80,000 per month. The injectable version is expected to launch soon.
Despite the high costs, Rybelsus sales have notched up ₹418 crore, between its launch in 2022 and March 2025, according to Pharma data agency IQVIA.
Mounjaro's injectables, available in India, cost far less— ₹17,500 per month.
'Since India sells branded generic dosages, the retail price of new launches will be 40-70% of the innovator's price," Ravinder Singha, managing director of Firmlink Pharma, a generic exporter, said. 'But since Mounjaro is the benchmark treatment, we should expect semaglutide drugs to be substantially cheaper," he added.
Semaglutide tablets, therefore, could be available for ₹4000- ₹7000 per month and Wegovy clones at a bigger discount to Mounjaro's ₹17,500 per month.
'Generic brands in India will hit the shelf the next day a drug goes off patent," said Nimish Mehta, founder of Research Delta Advisors, a pharma consultancy.
So, Indian generics should be available from April 2026 onwards.
Meanwhile, Indian pharmacies have acknowledged the growing demand for such drugs.
'These GLP-1s…everyday we are selling huge quantities," Shobana Kamineni, executive chairperson of Apollo Health Co and Apollo Pharmacies, said.
Medications used to treat obesity and type 2 diabetes are classified as GLP-1 (glucagon-like peptide-1) drugs.
The science
GLP-1 is an equivalent of peptide glucagon that is produced in the small intestine and colon after ingestion of food which increases blood sugar. Glucagon then stimulates the pancreas to produce insulin to control blood sugar.
GLP-1 drugs behave like synthetic glucagon and stimulate the same effects from the body. In addition, GLP-1 drugs leave the user with a feeling of fullness that sends a message to the brain to slow down the ingestion of food.
From the last decade, there is enough evidence that the new class of GLP-1 drugs, like semaglutide and tirzepatide, offer weight reduction between 21-23% of the initial body weight without any severe side effects. And as anti-diabetic drugs, they were meant for prolonged use. 'In the range of medication for management of obesity, (GLP-1s) have proven to be the game changer," bariatric surgeon Dr Muffazal Lakdawala told Mint.
Historically, GLP-1 class of drugs did not see much competition for two reasons. Initially, these drugs were marketed as an anti-diabetic injection—there were already many competing drugs available in that space.
Second, glucagon being a peptide hormone, an organic substance, the drugs had to emulate their form and structure. Like insulin, they can be produced by fermentation or by chemical synthesis and both have their complexities. Producing large quantities of fermentation medicines like insulin or penicillin require high investments, both in manufacturing and cold supply chains.
Even in the oral version of semaglutide, which is manufactured by chemical synthesis, the manufacturing process is a long and complex one. Oral delivery of peptides does not permeate the gastrointestinal tract easily and, therefore, Novo Nordisk had to engineer its product differently to ensure potency.
US dreams
Despite all the complexities, Indian companies want to grab the opportunity the US, global and Indian markets present. Let's look at the US first.
Companies like Sun Pharma, Dr. Reddy's, Lupin and Natco Pharma (which has a tie-up with Mylan Pharmaceuticals) filed applications with the US Food and Drug Administration (FDA) to make the generic versions of semaglutide the same month—December 2021. They did so to avail what is called the first-to-file (FTF) status. Overall, 18 Indian companies have applied.
Generic applications in the US are filed way before patents expire and an FTF allows a company to market its generic for 180 days exclusively in the US, before more cheaper generics hit the market.
Natco (through Mylan) is the only company to have sought approval for generic Wegovy.
The US FDA has not yet approved any generic so far.
'Since an application to the FDA will include a sample of the product and details of manufacturing plants, we can assume that there is enough confidence among Indian players to make the drug," Mehta of Research Delta Advisors said.
India stack
A long list of companies, from different pharma sub-sectors, could benefit from the weight-loss bonanza.
For the domestic market and for generic exports to countries where no patents exist, the list of companies waiting to launch semaglutide next year includes Dr. Reddy's, Sun Pharma, Cipla, Zydus Lifesciences, Lupin, Mankind Pharma, Alkem Laboratories, Biocon, Aurobindo Pharma, Natco and Torrent Pharmaceuticals among others.
Zydus Lifesciences is working on a single pen device in multiple strengths, The Economic Times reported last month. It is also working on a novel formulation for semaglutide to commercialize in India and other markets. 'We are on track for day one launch in India," managing director Sharvil Patel told investors during an earnings call last month.
Cipla, meanwhile, is eyeing the launch of GLP-1s through partnerships as well as through its own generic version. In a post-earnings media interaction recently, the company's managing director and global CEO Umang Vohra said: 'I think the biggest opportunity for us, at least, would continue to be the Indian market."
Biocon has already launched another GLP-1, liraglutide, in India earlier this month. 'Our strategy is to offer liraglutide at competitive prices, aligned with local healthcare economics to maximize patient access in India," a company spokesperson told Mint in an email response.
Biocon plans to launch semaglutide in India mid-next year, CEO Siddharth Mittal had told Mint in an earlier interview. The company now plans to expand its manufacturing capabilities to ensure supply reliability, it said in the emailed response.
Sun Pharma and Mankind are also working on their own novel anti-obesity drugs. Sun Pharma is working on a novel GLP-1 GL0034 called utreglutide, which will likely be commercialized by the end of this decade.
Mankind's drug candidate, GRP119, is currently in phase 2 trials in Australia. For the generic version of semaglutide, the company is banking on its salesforce and reach to give it a competitive edge, managing director Rajeev Juneja told Mint in an earlier interview.
'Any doctor would want to prescribe it, because now people know that there is something called Mounjaro, or semaglutide or Ozempic," Juneja said. 'We, by default, have a natural advantage because we have the deepest coverage, we have the maximum number of people working in each division," he added.
Further, players like Divi's Laboratories, a manufacturer of active pharmaceutical ingredients, and Syngene International, a contract research, development and manufacturing company, can also benefit from the gold rush.
'Divi's Laboratories will be a key beneficiary in GLP-1 manufacturing as it makes several components in the peptide sequence," Shrikant Akolkar, head of pharmaceutical research at Nuvama, a brokerage, said.
OneSource Specialty Pharma, the contract development and manufacturing arm of Strides Pharma, is among the few companies with end-to-end capabilities for GLP-1s—from formulation to device assembly. 'The most complex part of the whole value chain is to assemble the pen devices," OneSource Pharma's CEO, Neeraj Sharma, told Mint during a recent interaction.
Another company, Vadodara-based Shaily Engineering Plastics, says it is nearly doubling its manufacturing line to make injectable pens—from 45 million to 85 million—funded by customer advances.
A caution
Clearly, speed to market will separate the winners from the also-rans.
'Early movers among the Indian players stand a good chance to benefit from GLP-1," said Akolkar. A recent report by Nuvama put a buy on Dr. Reddy's and Divi's Laboratories and a hold on Natco Pharma based on their GLP-1 play.
Nonetheless, some doctors fear misuse of the drug because of its popularity.
A prescription for diabetic drugs can be written by any medical practitioner. Weight loss clinics in the unorganised sector could start dispensing the drug for cosmetic purposes. For instance, a person in her 20s, who is slightly overweight, may be tempted to use these drugs instead of trying to lose weight by making lifestyle changes.
'We need some regulations to prevent over-the-counter use for weight loss," Dr Muffazal Lakdawala said. 'It is a hormonal drug so you have to be a little careful."