Lupin Limited has informed the Exchange regarding a press release dated May 18, 2026, titled "Lupin Receives Tentative Approval from U.S. FDA for Revefenacin Inhalation Solution".
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Lupin Limited has received tentative approval from the U.S. FDA for its Revefenacin Inhalation Solution, 175 mcg/3 mL Unit-Dose Vials. The drug is bioequivalent to Mylan's Yupelri® Inhalation Solution and is used for maintenance treatment of Chronic Obstructive Pulmonary Disease (COPD) patients. The reference drug Yupelri® had estimated annual sales of USD 260.7 million in the U.S. market as of March 2026. This tentative approval allows Lupin to market a generic version of this COPD treatment pending final approval. Lupin is a global pharmaceutical company headquartered in Mumbai with presence in over 100 markets.
The FDA tentative approval is positive for Lupin as it opens the door to entering the U.S. COPD market with a generic version of a drug with over USD 260 million in annual sales. This could contribute to revenue growth once final approval is granted and the product is launched.