Transpire Bio Inc., a clinical-stage biopharmaceutical company focused on inhaled treatments for lung and systemic disorders, announced that the U.S. Food and Drug Administration (FDA) has accepted its abbreviated new drug application (ANDA) for fluticasone furoate, umeclidinium, and vilanterol inhalation powder. This formulation serves as a generic equivalent to the high-strength Trelegy^® Ellipta^®¹ (200 mcg/62.5 mcg/25 mcg).

According to FDA public records,² Transpire Bio appears to be the first filer of an ANDA for this high-strength version, including a Paragraph IV certification per the Hatch-Waxman Act. If approved, the company anticipates gaining 180 days of market exclusivity.

In the United States, Trelegy^® Ellipta^® is approved for maintaining treatment of asthma in adults 18 and older, as well as for chronic obstructive pulmonary disease (COPD) maintenance. IQVIA data shows U.S. annual sales for Trelegy^® Ellipta^® reaching $8 billion in 2025.³

"The FDA's decision to accept our ANDA for this interchangeable generic of high-strength Trelegy^® Ellipta^® marks a key achievement in our development efforts and broader complex generics portfolio," stated Dr. Xian-Ming Zeng, CEO of Transpire Bio. "Our skilled team in South Florida consistently surpasses expectations. With our initial ANDAs for generic Breo^® and Trelegy^® secured as first-to-file, and this one poised as our third, we are advancing toward offering cost-effective access to vital therapy for asthma and COPD patients."

"This accomplishment highlights Transpire Bio's expertise in creating sophisticated drug-device combinations. We take great pride in our team's profound scientific and technical prowess as they deliver on our strategic goals," remarked Dr. Abhishek Gupta, Chief Scientific Officer at Transpire Bio.

Beyond its complex generics initiative, Transpire Bio is advancing a lineup of novel inhaled drugs targeting Idiopathic Pulmonary Fibrosis (IPF) and Progressive Pulmonary Fibrosis (PPF), with three candidates underway. The company is also pursuing treatments for Pulmonary Arterial Hypertension (PAH), Diabetes, Obesity, Parkinson's Disease Psychosis, and Glioblastoma. All development and production occur at Transpire Bio's advanced facilities 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 a U.S.-based, clinical-stage biopharmaceutical company based in Sunrise, Florida. Leveraging its inhalation drug formulation and delivery know-how, the firm addresses unmet needs in respiratory and systemic diseases. It has created proprietary platforms like dry-powder and soft-mist inhalers, fueling a pipeline for IPF, PPF, PAH, Diabetes, Obesity, Parkinson's Disease Psychosis, and Glioblastoma. Visit www.transpirebio.com for details.

SOURCE Transpire Bio