After an early lead in Semaglutide generics, Torrent Pharmaceuticals is now positioning itself for what could be a more differentiated play—bringing the US-approved liver disease drug Resmetirom to India once patent barriers ease.
Managing director Aman Mehta said the Ahmedabad-based company is currently running a Phase 3 clinical trial in India for the drug, which has already been approved in the United States under the brand Rezdiffra by Madrigal Pharmaceuticals.
“We are currently conducting a Phase 3 clinical trial for Resmetirom in India,” Mehta told investors on Friday. “Assuming the trial completes successfully within our projected timelines, we may be among the first to launch this in the India market after patent expiry. This is presently projected to be a large sized opportunity for us,” he added.
Resmetirom is the first approved therapy in the US specifically for metabolic dysfunction-associated steatohepatitis (MASH), earlier known as NASH—a progressive fatty liver disease linked to obesity, diabetes and poor metabolic health.
The condition leads to fat accumulation in the liver, followed by inflammation and scarring, and can eventually progress to cirrhosis or liver failure if untreated.
Mehta said there is currently no innovative treatment available in India for this condition, suggesting a potential opening for early entrants once regulatory and patent-related constraints ease. While he did not share a definitive launch timeline, he indicated that entry could be possible within 12–18 months after patent expiry, subject to successful clinical outcomes and approvals.
Alongside its pipeline push, Torrent has also made an early start in the fast-growing semaglutide market with two branded launches—Semalix (oral) and Sembolic (injectable). Semaglutide, widely used in diabetes management and increasingly in obesity care, has seen rapid generic activity in India following patent expiry dynamics in key markets.
Mehta said the launch has seen strong initial traction and helped the company secure a leading position among early generic entrants.
Based on Pharmatrac April data cited by the company, Torrent held a 38 per cent share among generic players in the semaglutide market, including 28 per cent share in injectables and 100 per cent share in oral formulations at that time.
However, he acknowledged that the competitive landscape is evolving. As of May 21, another competitor has entered the oral segment, which is expected to impact near-term share dynamics.
Despite this, Torrent believes its early entry across both dosage formats has helped it build prescription momentum.
“Early availability in both oral and injectable formats has given us a strong start,” Mehta said, adding that first-mover advantage typically plays a key role in chronic therapy markets where physician adoption builds over time.
To explain the scale of the opportunity, Mehta compared semaglutide with one of the company’s earlier successful diabetes launches in 2023.
He referred to sitagliptin (a widely used diabetes drug in the DPP-4 class), which had been one of Torrent’s best-performing launches in the last decade.
That product generated about ₹70–75 crore in its first year and helped the company secure roughly 20–22 per cent share in the generic diabetes segment. In simple terms, sitagliptin was a strong but “standard generic success”—a crowded diabetes drug where many companies compete and growth is steady rather than explosive.
In contrast, Mehta said semaglutide is shaping up very differently. He estimated that semaglutide alone could generate ₹200–250 crore, calling it a significantly larger opportunity than past launches.
“It is anyone’s guess what the market size could be in 3–5 years, but certainly it is looking to be significantly larger than any product launch that we have seen,” Mehta said.