Cipla gets US FDA approval for generic asthma/COPD inhaler; first from US facility
Cipla has received approval from the U.S. Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA) for a generic version of Advair Diskus, a combination inhalation powder used to treat asthma and chronic obstructive pulmonary disease (COPD).
The approval covers three strengths — 100/50 mcg, 250/50 mcg, and 500/50 mcg — of fluticasone propionate and salmeterol inhalation powder. This marks Cipla's first dry powder inhaler (DPI) approval from its U.S.-based manufacturing network. The company said on Monday that the product is expected to launch in the second quarter (Q2) of the financial year 2026-27 (FY27) in the U.S.
Advair Diskus is a widely prescribed combination therapy that helps reduce inflammation and open airways in patients with asthma and COPD. Cipla's generic version is therapeutically equivalent to the branded drug, meaning it can be substituted for the original. According to IQVIA data, the U.S. market for fluticasone propionate and salmeterol inhalation powder is approximately $908 million.
Marc Falkin, CEO of Cipla North America, said, "This approval marks our first dry powder inhaler from our New York facility and reflects our targeted investments in building differentiated inhalation manufacturing capabilities in the U.S." Achin Gupta, Managing Director and Global CEO of Cipla, said the approval reinforces the company's commitment to expanding access to complex therapies in the U.S. and highlights its strength in developing and scaling sophisticated inhalation products through integrated capabilities.
The approval is a significant step for Cipla as it strengthens its position in the U.S. generics market, particularly in the respiratory segment. Respiratory therapies have been a key focus area for the company, which has multiple manufacturing facilities across the world. The U.S. is one of the largest pharmaceutical markets globally, and approvals for complex generics are seen as a major milestone for Indian pharmaceutical companies.
Asthma and COPD are chronic respiratory diseases affecting hundreds of millions of people worldwide. According to the World Health Organization, asthma affected an estimated 262 million people in 2019 and caused 455,000 deaths. COPD is the third leading cause of death globally, responsible for 3.23 million deaths in 2019. Access to affordable generic versions of essential inhalers is crucial for improving patient outcomes and reducing healthcare costs.
The launch of Cipla's generic version is expected to increase competition and potentially lower drug prices in the U.S., where respiratory medications are among the most prescribed. Generic competition often leads to significant cost savings for patients and health systems.
Cipla has been investing in specialized manufacturing capabilities to develop complex therapies, including inhalers that require precise formulation and delivery mechanisms. The New York facility, which is part of its global manufacturing network, will play a key role in producing the approved product.
This approval adds to Cipla's track record of gaining U.S. FDA approvals for complex products. The company's focus on complex generics is part of a broader strategy to differentiate itself in competitive markets and expand its portfolio beyond traditional dosage forms.
Neither Cipla nor the FDA provided additional details about the approval timeline or potential market entry beyond the company's expected launch in Q2 FY27. Investors reacted positively to the announcement, reflecting confidence in Cipla's growth prospects.
