Lupin Receives U.S. FDA Tentative Approval for Generic Revefenacin Inhalation Solution

20 May 2026 | Wednesday | News

Tentative approval for bioequivalent version of Yupelri® strengthens Lupin’s respiratory portfolio in the U.S. market, where the COPD therapy recorded annual sales of $260.7 million.

Global pharmaceutical leader Lupin Limited (Lupin) (BSE: 500257) (NSE: LUPIN) (REUTERS: LUPIN.BO) (BLOOMBERG: LPCIN) announced that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Revefenacin Inhalation Solution, 175 mcg/3 mL Unit-Dose Vials.

Lupin's Revefenacin Inhalation Solution, 175 mcg/3 mL is bioequivalent to Mylan's Yupelri® Inhalation Solution and indicated for the maintenance treatment of patients with Chronic Obstructive Pulmonary Disease (COPD).

Revefenacin Inhalation Solution (RLD Yupelri®) had estimated annual sales of USD 260.7 million in the U.S. (IQVIA MAT March 2026).

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Lupin Receives U.S. FDA Tentative Approval for Generic Revefenacin Inhalation Solution