Transpire Bio’s ANDA for Generic Breo® Ellipta® Accepted for Filing By the U.S. FDA
SUNRISE, Fla., Sept. 23, 2025 (GLOBE NEWSWIRE) -- Transpire Bio, an integrated clinical-stage biopharmaceutical company focused on developing inhaled therapeutics for pulmonary and systemic diseases, today announces that its abbreviated new drug application (ANDA) for fluticasone furoate and vilanterol inhalation powder, a generic version of Breo® Ellipta®1 100/25, has been accepted for filing by the U.S. Food and Drug Administration (FDA). Based on FDA’s public records,2 Transpire Bio believes that it was the first to file an ANDA with a Paragraph IV certification under the provisions of the Hatch-Waxman Act. Should its ANDA be approved by FDA, Transpire Bio believes it will be eligible for 180 days of market exclusivity. In the U.S., Breo® Ellipta® is indicated for the maintenance treatment of patients with asthma and the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). According to IQVIA, Breo® Ellipta® reported U.S. annual sales of $2.02 Billion3 in 2024.
“The FDA’s acceptance of our ANDA for filing is an important achievement for our generic Breo Ellipta development program and our complex generic franchise as a whole,” said Dr. Xian-Ming Zeng, Chief Executive Officer of Transpire Bio. “I am proud of our highly experienced team in South Florida who have worked tirelessly with world class CDMOs and other partners since the inception of Transpire Bio to achieve this important milestone. We are now one step closer to providing patients suffering from asthma or COPD, an affordable option and improved access to this critical medication.” “This milestone represents the culmination of years of investment in the right technical competence and infrastructure and demonstrates Transpire Bio’s capabilities in developing complex drug device combination products,” said Dr. Abhishek Gupta, Chief Scientific Officer of Transpire Bio.
In addition to its focused generic franchise, Transpire Bio is building a pipeline of innovative inhalation medicines for Idiopathic Pulmonary Fibrosis (IPF) where it has three assets in development. Transpire Bio is also developing therapies for Pulmonary Arterial Hypertension (PAH), Diabetes, Obesity, Parkinson Disease Psychosis and Glioblastoma. These products will all be developed and manufactured in Transpire Bio’s state-of-the-art manufacturing facilities located in South Florida, U.S.
About Transpire Bio Inc.
Transpire Bio Inc. is an integrated US-based, clinical-stage biopharmaceutical company headquartered in Sunrise, Florida. Transpire Bio harnesses its inhaled drug delivery expertise to improve patients’ lives by expanding access to important therapies and developing treatments for serious diseases where therapeutic options are significantly lacking. Transpire Bio has developed multiple proprietary inhalation technology platforms, including dry powder inhalers, soft-mist inhalers and metered-dose inhalers. For more information, please visit www.transpirebio.com.
- Breo® Ellipta® is a registered trademark of GSK group of companies.
- See FDA’s list of drug products for which an ANDA has been received by the Office of Generic Drugs containing a “Paragraph IV” patent certification.
- Data on file with the company.
Contacts:
Corporate
info@transpirebio.com
+1 954.908.2233
Investors
Stuart Loesch
Chief Commercial Officer, Transpire Bio
Stuart.loesch@transpirebio.com
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