MoneyWorks4Me

Lupin gets USFDA tentative approval for Revefenacin Inhalation Solution

19 May 2026 Evaluate

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.


Peers
Company Name CMP
Sun Pharma. Inds. 1860.00
Dr. Reddys Labs. 1250.00
Cipla 1383.00
Lupin 2060.00
Zydus Lifesciences 1195.20
View more..