Lupin has received tentative approval from the United States Food and Drug Administration (USFDA) 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 $260.7 million in the U.S. (IQVIA MAT March 2026).
Lupin is an innovation led transnational pharmaceutical company producing, developing and marketing a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.