Lupin Limited announced that it has received tentative approval from the United States Food and Drug Administration (US FDA) for its abbreviated new drug application for Revefenacin Inhalation Solution, 175 mcg/3 mL unit-dose vials. The approved product is the generic equivalent of Yupelri® Inhalation Solution developed by Mylan and is indicated for the maintenance treatment of patients suffering from Chronic Obstructive Pulmonary Disease (COPD). Lupin stated that its product has been found bioequivalent to the reference listed drug.
According to IQVIA MAT data for March 2026, the reference product recorded estimated annual sales of USD 260.7 million in the United States, highlighting the market opportunity for the respiratory therapy product. The tentative approval marks another milestone in Lupin’s expanding respiratory portfolio and further strengthens its position in the U.S. generics market, particularly in complex inhalation therapies.
Chronic Obstructive Pulmonary Disease remains one of the leading chronic respiratory conditions globally, requiring long-term maintenance therapy to manage symptoms and improve patient quality of life. The approval is expected to support broader access to affordable treatment options in the U.S. healthcare market once final approval conditions are met.
Headquartered in Mumbai, Lupin has established itself as a major global pharmaceutical company with operations spanning more than 100 markets worldwide. The company’s portfolio includes branded and generic formulations, biotechnology products, active pharmaceutical ingredients, and complex generics across multiple therapeutic areas.
Lupin maintains a significant presence in India and the United States in therapy segments including respiratory care, cardiovascular medicine, anti-diabetics, anti-infectives, gastrointestinal treatments, women’s health, and central nervous system therapies. The company currently operates 15 manufacturing facilities and seven research centers globally, supported by a workforce of more than 24,000 employees. Through its subsidiaries, including Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions, the company continues to focus on expanding healthcare access and improving patient outcomes through innovation and technology-driven solutions.
