In a significant development for diabetes and obesity care, the patent for semaglutide - the key molecule behind blockbuster drugs like Ozempic and Wegovy, expired on March 20. Originally developed by Danish pharmaceutical giant Novo Nordisk, semaglutide has been widely regarded as a breakthrough in managing type 2 diabetes and aiding weight loss.
With the patent expiry, multiple Indian pharmaceutical companies have now entered the market with generic versions of the drug, reducing costs and potentially expanding access to millions of patients.
This development comes at a critical time. According to data from the Indian Council of Medical Research–INDIAB study, approximately 101 million Indians are living with diabetes, while 136 million have prediabetes. Alongside this, the country faces a massive obesity burden, with an estimated 254 million people classified as generally obese and 351 million experiencing abdominal obesity.
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Experts say this could be a turning point in India’s fight against ‘diabesity’, improving affordability and access, but also requiring stricter oversight to prevent misuse.
Affordability and access
Until recently, semaglutide-based therapies remained out of reach for a large section of the population due to their high cost. Injectable drugs such as Ozempic and Wegovy were priced between Rs 8,000 and Rs 16,000 or more per month in India. Even Rybelsus, the oral version, cost between Rs 2,300 and Rs 3,300 monthly.
However, following the patent expiry, at least seven pharmaceutical companies have launched generic semaglutide formulations priced between Rs 1,290 and Rs 4,200 per month. This represents a reduction of nearly 65–90% compared to earlier prices.
What experts say
Dr Rajiv Kovil, Head of Diabetology and Weight Loss Expert at Zandra Healthcare, emphasised that semaglutide is not a new or untested drug, but one backed by strong scientific evidence. He noted that the molecule has been studied extensively over the years.
“Semaglutide is an 11-year-old molecule with nearly 50 clinical trials behind it. It has very robust data, largely built by Novo Nordisk,” he said.
Originally introduced for diabetes management, the drug now has a much broader role globally. “It is now indicated for diabetes, weight management, and even reducing heart disease risk in people with or without diabetes who have obesity,” he explained.
Highlighting its clinical benefits, he pointed out that semaglutide has demonstrated significant risk reduction across multiple conditions. “There is about a 28% reduction in heart disease risk and nearly a 24% reduction in kidney-related events. It also reduces cardiovascular events by around 20% in people with obesity and heart disease,” he said.
He added that the drug also shows promise in improving metabolic conditions like fatty liver disease, although this indication is not yet approved in India. “A large proportion of patients with diabetes, nearly 70%, have fatty liver, 40% have kidney disease, and 25% have established heart disease. So, this drug can benefit a wide spectrum of patients,” he noted.
On weight loss, Dr Kovil explained that semaglutide offers gradual and sustained results. “It can lead to about 15–16% weight loss over time, even in people without diabetes. The weight loss is slow, sustained, and typically peaks over a year,” he said.
Challenges, access and need for regulation
However, Dr Kovil cautioned that the shift to generics comes with certain challenges. Unlike the original biologic drug, generic versions are synthetically manufactured, making production more complex.
“Semaglutide is a peptide and a difficult drug to manufacture. It also requires strict cold chain maintenance—from production to storage and distribution. Any break in this chain can lead to batch-to-batch variation,” he explained.
He pointed out that while Indian pharmaceutical companies have strong capabilities, this marks a relatively new space for many of them. “This is the first time many companies are entering peptide-based products like this, so maintaining cold chain integrity will be crucial,” he added.
Dr Kovil welcomed the price reduction, saying it would improve access for a larger section of the population. However, he strongly cautioned against misuse.
“When prices come down, more people, especially the middle class, will be able to afford it. But this is not a magic bullet for weight loss,” he said.
He stressed that semaglutide must always be used under medical supervision, with careful patient selection and counselling.
“It requires detailed patient education - how to take the drug, how to gradually increase the dose, what side effects to expect, and how to manage them. Doctors often need to spend significantly more time counselling patients on this therapy,” he explained.
Dr Kovil also highlighted the importance of following strict prescription guidelines, particularly in the context of obesity treatment.
“In India, the criteria are clear. If BMI is above 30 without comorbidities, or above 27 with conditions like hypertension, cholesterol issues, PCOS, or sleep apnea, semaglutide can be prescribed,” he said.
“It is very crucial that semaglutide is given only through a proper prescription,” he said, adding that prescriptions should clearly mention both the patient’s diagnosis and body mass index (BMI).
Dr Kovil emphasised that this step is necessary to prevent misuse, particularly for non-medical or cosmetic weight loss. “The prescription should carry the BMI and the diagnosis so that nobody is prescribing it for cosmetic weight loss, where the patient does not actually need to lose weight,” he explained.
He also called for tighter governance and monitoring mechanisms. “There has to be stronger oversight, possibly from government and enforcement authorities, to ensure that these guidelines are followed,” he said, reiterating that maintaining prescription discipline will be key to ensuring safe and appropriate use of the drug.
This story is done in collaboration with First Check, which is the health journalism vertical of DataLEADS