Lupin Limited has informed the Exchange regarding a press release dated December 05, 2025, titled "Lupin Receives Tentative Approval from U.S. FDA for Siponimod Tablets".
LUPIN · price
▲ positive · ▼ negative · ● neutral filings · teal = economic event · numbered = multiple that day (click to pick). Times IST.
Awaiting price reaction for this filing.
Lupin has received tentative approval from the U.S. FDA for Siponimod Tablets, which is a generic version of Novartis's Mayzent used to treat relapsing forms of multiple sclerosis. A tentative approval means the FDA has found the drug meets all safety, efficacy, and quality standards but Lupin cannot commercially launch it in the U.S. market until existing patents or exclusivity periods on the brand-name drug expire. This approval strengthens Lupin's pipeline of complex generics targeting the U.S. market, which is one of the company's key growth drivers.
Positive for Lupin as it adds another product to its U.S. generics portfolio, though actual revenue impact will only materialize once the patent hurdle is cleared and the product is launched. Shareholders may see modest long-term benefit depending on the market size and launch timing.