Lupin Gets US FDA Tentative Approval for COPD Drug Revefenacin
Lupin Limited announced tentative U.S. FDA approval for its Revefenacin Inhalation Solution for COPD maintenance treatment. The drug is bioequivalent to Mylan's Yupelri®. The reference drug had estimated U.S. sales of USD 260.7 million in March 2026.
The drug targets a significant market (COPD) and the reference product has substantial sales, indicating a good market potential. However, it is a tentative approval, and actual market entry and sales will depend on final approvals and market reception.
The tentative approval from the U.S. FDA for a new drug application is a positive development for the company, potentially leading to future revenue generation.
Lupin Limited has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Revefenacin Inhalation Solution, 175 mcg/3 mL Unit-Dose Vials.
This inhalation solution is indicated for the maintenance treatment of patients with Chronic Obstructive Pulmonary Disease (COPD). Lupin's Revefenacin Inhalation Solution is bioequivalent to Mylan's Yupelri® Inhalation Solution.
The estimated annual sales for the reference listed drug, Revefenacin Inhalation Solution (RLD Yupelri®), in the U.S. were USD 260.7 million as of March 2026 (IQVIA MAT March 2026). The announcement was made on May 18, 2026.
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