Transpire Bio's ANDA for Generic High-Strength Trelegy® Ellipta® Accepted for Filing by the U.S. FDA
SUNRISE, Fla., May 11, 2026 /PRNewswire/ -- Transpire Bio Inc., an integrated clinical-stage biopharmaceutical company developing inhaled therapeutics for pulmonary and systemic diseases, today announces that its abbreviated new drug application (ANDA) for fluticasone furoate, umeclidinium, and vilanterol inhalation powder, a generic version of the high-strength Trelegy® Ellipta®1 (200 mcg/62.5 mcg/25 mcg) product, has been accepted for filing by the U.S. Food and Drug Administration (FDA).
Based on the FDA's public records,2 Transpire Bio believes that it was the first company to file an ANDA for the high-strength product with a Paragraph IV certification under the provisions of the Hatch-Waxman Act. Should Transpire Bio's ANDA be approved by the FDA, Transpire Bio believes it will be eligible for 180 days of market exclusivity.
In the U.S., Trelegy® Ellipta® is indicated for the maintenance treatment of asthma in patients 18 years and older and the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). According to IQVIA, Trelegy® Ellipta® reported U.S. annual sales of $8 Billion in 2025.3
"The FDA's acceptance of our ANDA filing for the substitutable generic version of high-strength Trelegy® Ellipta® is another major milestone in advancing our development program and our complex generic franchise as a whole," said Dr. Xian-Ming Zeng, Chief Executive Officer of Transpire Bio. "Our highly experienced team in South Florida continues to meet and exceed each challenge put in front of them. With our first two ANDAs for generic Breo® and Trelegy® now confirmed as first-to-file, and this ANDA as our potentially third first-to-file, we move one step closer to providing patients suffering from asthma or COPD with an affordable option and improved access to this critical medication."
"This milestone demonstrates Transpire Bio's strong capabilities in developing complex drug device combination products. We are extremely proud of the deep scientific and technical competence of our Transpire Bio team to constantly execute against our strategic plan," said Dr. Abhishek Gupta, Chief Scientific Officer of Transpire Bio.
In addition to its focused complex generic franchise, Transpire Bio is building a pipeline of innovative inhalation medicines for Idiopathic Pulmonary Fibrosis (IPF) and Progressive Pulmonary Fibrosis (PPF), with three assets in development. Transpire Bio is also developing therapies for Pulmonary Arterial Hypertension (PAH), Diabetes, Obesity, Parkinson's Disease Psychosis, and Glioblastoma. These products are being developed and manufactured in Transpire Bio's state-of-the-art manufacturing facilities located in South Florida, U.S.
- Trelegy® Ellipta® is a registered trademark of the GSK group of companies.
- FDA's "Paragraph IV" patent certification list
- IQVIA NPA (US SMART Edition). Data on file.
About Transpire Bio Inc.
Transpire Bio Inc. is an integrated US-based, clinical-stage biopharmaceutical company headquartered in Sunrise, Florida. Transpire Bio is innovating by applying its deep inhalation drug formulation and delivery expertise to respiratory and systemic diseases where currently available options are significantly lacking. Transpire Bio has developed multiple proprietary inhalation technology platforms, including dry-powder inhalers and soft-mist inhalers, and is progressing a pipeline of innovative inhalation medicines for Idiopathic Pulmonary Fibrosis (IPF), Progressive Pulmonary Fibrosis (PPF), Pulmonary Arterial Hypertension (PAH), Diabetes, Obesity, Parkinson's Disease Psychosis, and Glioblastoma. For more information, please visit www.transpirebio.com.
SOURCE Transpire Bio
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