Weight-loss drug boom in India: As patent lapses, generic Ozempic, Wegovy shots may cost Rs 3,000– Rs 4,000 per month

With the semaglutide patent expiring, the weight loss drug boom in the West is now expected to hit India more strongly with generics, which will be the same as brand-name drugs in dosage, safety, strength, quality and performance, but usually cost significantly less as they do not have to repeat costly clinical trials.

Why semaglutide has been sought after

Semaglutide has been a hot-seller because it mimics the GLP-1 hormone, which is released in the gut after eating, to stimulate insulin production, lower blood sugar, slow digestion and reduce appetite. It was first approved for the treatment of Type-2 diabetes by the US Food and Drug Administration in 2017. However, it soon gained popularity for its off-label use as a weight-loss agent. A higher dose version of the medicine was finally approved for weight-loss by the US FDA in 2021.

Danish pharma major Novo Nordisk, the primary patent holders of semaglutide, sold Ozempic primarily for Type 2 diabetes but its appetite-suppressing ability made it highly effective for weight management. Its Wegovy is specifically tailored to control chronic obesity. Both were launched in India last year before the patent expired.

However, US pharma giant Eli Lilly’s tirzepatide drug Mounjaro, that mimics an additional hormone, GIP, alongside GLP-1, will not have generics soon. Its patent lasts till 2035 and commands 61 per cent of the Indian weight loss market. Eli Lilly has, however, partnered with Cipla to sell branded tirzepatide while firms like Biocon are preparing injectables for launch in 2027.

How will the Indian market look like

While nearly 50 brands will be launched, only three or four of the bigger brands are likely to grab a share in the pie. “Other brands from smaller companies, which only a few doctors prescribe, are likely to fade away. This is what we have seen with other diabetes drugs that have gone off patent,” said Sheetal Sapale, vice president (commercial), Pharmarack.

Despite the competition, the two market leaders — Novo Nordisk and Eli Lilly — are unlikely to change their current price point. “We are driven by patients, not patents. Patent expiry is a natural part of the pharmaceutical product lifecycle, and we are well-positioned to navigate this evolving landscape. Semaglutide carries a strong clinical evidence base of proven safety and efficacy with over 50 robust clinical trials across Type 2 diabetes, obesity, heart, liver and kidney disease. This is complemented by 49 million patient years of exposure, extensive real-world evidence, world-class r-DNA manufacturing process, state-of-the-art device and delivery system and high safety standards,” said Vikrant Shrotriya, managing director of Novo Nordisk, India.

While the newer drugs are likely to eat into some of Mounjaro’s market share, the change is not likely to happen immediately. “The people who are already on Mounjaro or Wegovy can afford these drugs. They are unlikely to shift to the generic versions immediately despite the lower costs. This is because they value the premium quality of the innovator products and a shift to a new product may lead to the initial side effects again,” said Sapale.

She added that the lower-cost generic versions are likely to lead to a two-to-three fold surge in the number of people using it, including those who kept away from the drug because of its prices.

“Generics are likely to capture a bigger volume share as GLP-1 therapy becomes more affordable, accessible, and awareness about management of diabetes and obesity goes up… This is expected to enable more patients to initiate therapy while also supporting continuity of treatment,” said Dr Vikas Gupta, Chief Executive Officer, Alkem Laboratories. The company is set to launch its generic version of semaglutide on the first day of patent expiry.

What’s the sales pitch of generic manufacturers?

Several drug manufacturers would be launching multiple brands. For example, Zydus Lifesciences plans to launch Semaglyn, Mashema and Alterme.

Companies are also looking at innovations to capture the market. Again, Zydus will launch semaglutide pens, which can be used multiple times, allowing patients to select and administer varying dose strengths from a single unit, which is particularly useful during the titration phase (gradually increasing the dose). The pens available so far could dispense the drug only in a single dosage, meaning patients had to buy different pens for different doses.

Dr Sharvil Patel, managing director of Zydus, said, “We are not just planning to bring a critical therapy to market, we are aiming to elevate the standard of care. By introducing the new drug delivery mechanism in India, we plan to simplify the treatment. This leap in convenience will drive better long-term adherence.” And push down costs too.

Misuse, excessive marketing push

With the popularity of GLP-1 drugs — driven by celebrity endorsements when the first products were launched globally —  there is a risk of misuse. A strong marketing push is already palpable, with companies reaching out to doctors and driving “awareness campaigns”, according to an industry expert.

That’s why the apex drug regulator, the Central Drugs Standard Control Organisation (CDSCO) has issued an advisory warning manufacturers against such advertising. It said: “any promotional activity carried out under the pretext of disease awareness, influencer engagement, corporate campaigns or similar activities that create brand recall or product visibility of the prescription product, shall also be treated as violations.”

Local chemist stores are also internalising discipline. “We have written to all our members to ensure that they dispense the products only as per doctors’ prescription. We received complaints that in a few cases, Mounjaro was sold without one. That problem is likely to increase with many more drugs becoming available,” said Rajiv Singhal, general secretary of the All-India Chemists and Druggists Association.

Shrotriya, too, emphasized vigil, saying, “We strongly discourage self-medication or any form of misuse of these medicines.”

While semaglutide has been there in the market for years without such serious concerns, it does lead to adverse effects such as nausea, vomiting, and other gastrointestinal symptoms when people are starting out. It can also lead to serious side effects such as pancreatitis, thyroid cancer, and stomach paralysis.“Responsible use remains key. It is important to distinguish between medical obesity management and cosmetic weight loss, and ensure that the treatment is taken under appropriate medical supervision,” said Dr Gupta.