Lupin Limited has received tentative approval from the U.S. Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Revefenacin Inhalation Solution, 175 mcg/3 mL. This product is a bioequivalent version of Mylan’s Yupelri®, used for the maintenance treatment of patients with Chronic Obstructive Pulmonary Disease (COPD). The reference drug recorded estimated annual U.S. sales of USD 260.7 million as of March 2026.
Strategic Product Development
Lupin Limited announced on May 18, 2026, that it has secured tentative approval from the U.S. FDA to market Revefenacin Inhalation Solution in 175 mcg/3 mL unit-dose vials. This milestone highlights the company’s commitment to expanding its respiratory product portfolio, providing healthcare providers and patients with high-quality, bioequivalent treatment options for COPD.
Market Opportunity and Impact
The product is a bioequivalent version of the established treatment Yupelri®. According to IQVIA MAT data from March 2026, the reference product generated annual sales of approximately USD 260.7 million in the U.S. market. By securing this approval, Lupin continues to strengthen its footprint in the U.S. generic pharmaceutical sector, leveraging its robust manufacturing and research capabilities to capture significant market share in the respiratory therapy space.
Source: BSE
