Sun Pharma said it will launch generic semaglutide in India after the patent expiry in March 2026, becoming the second domestic drugmaker to secure regulatory approval for the blockbuster drug
Federal regulators have told drugmakers Novo Nordisk and Eli Lilly to remove label warnings about potential suicidal thoughts and behaviours from their blockbuster weight-loss medications. The US Food and Drug Administration on Tuesday said a comprehensive review found no increased risk related to suicide among users of the GLP-1 drugs for obesity, including Novo Nordisk's Wegovy and Saxenda and Eli Lilly's Zepbound. A preliminary review in January 2024 showed no link between the drugs and suicidal thought or actions, the FDA said. At that time, however, officials said they could not rule out that a small risk may exist. The new analysis puts those concerns to rest. Labeling for other drugs known as GLP-1 receptor agonists approved to treat diabetes carried no such warnings, the agency noted. Today's FDA action will ensure consistent messaging across the labelling for all FDA-approved GLP-1 RA medications, officials said.
The FDA had reached similar conclusion following a preliminary review in 2024, but had acknowledged at the time that it could not rule out a small risk because of limited data
The patent in question is due to lapse in March next year. The court is scheduled to take up Natco's challenge for further hearing in February
Patent expiries of blockbuster weight-loss drug semaglutide may create a ₹5,000 crore generic opportunity for Indian pharma firms across India and key emerging and regulated markets
Novo's strategy emphasises price cuts and accelerated launches, while Lilly's products benefitted from hitting the market early
US-listed shares of Novo jumped 8 per cent and Lilly fell 1 per cent in extended trading after the approval announcement
Novo will start selling the pill, the first of the blockbuster GLP-1 class, in the US in early January, the company said in a statement Monday
With Mounjaro gaining ground, launch comes just three months before Novo loses patent for semaglutide
Novo Nordisk's appeal is listed for hearing on Friday before a bench of Justice C Hari Shankar and Justice Om Prakash Shukla
The Delhi High Court refused to stop an earlier order that lets Dr Reddy's make Semaglutide in India only for export, saying Novo Nordisk's patent challenge needs a full hearing before any decision
The Delhi High Court has allowed Sun Pharma to manufacture and export semaglutide-based drugs to countries where Novo Nordisk holds no patent, but barred sales in India until March 2026
The approval marks a major win for Sun Pharma in its patent dispute with Danish drugmaker Novo Nordisk, the company that manufactures weight loss drug Ozempic
The dispute centres on Novo Nordisk's Indian patents for semaglutide, which it markets globally as Ozempic and Wegovy for Type 2 diabetes and weight management
Novo Nordisk cut Wegovy prices in mid-November, driving a 70% consumption jump and higher market share. Pharmarack data show Lilly's Mounjaro still dominates sales
The deal marks Healthify's first such partnership with a drugmaker, and it hopes similar agreements will boost its paid subscriber base
Novo Nordisk will strengthen its oral semaglutide portfolio led by Rybelsus while cutting Wegovy injection prices by up to 37% to improve accessibility and expand its market in India
Move comes in a bid to gain more space in India's anti-obesity market dominated by Mounjaro
2.4 mg injectable Poviztra to mark next phase of weight-loss rollout
The deal will help expand the availability and marketing of this weight-loss medicine, especially in areas where Novo Nordisk's reach is limited