Transpire Bio’s FDA-accepted ANDA for a generic high-strength Trelegy Ellipta could position the company for potential 180-day exclusivity in the U.S. inhaled respiratory market.
Written By: Karthik Teja Macharla, PharmD
Reviewed By: Pharmacally Editorial Team
Transpire Bio Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for filing its abbreviated new drug application (ANDA) for fluticasone furoate, umeclidinium, and vilanterol inhalation powder, a proposed generic version of the high‑strength Trelegy Ellipta 200 mcg/62.5 mcg/25 mcg product.
The company stated that, based on FDA public records, it believes it was the first to submit an ANDA for the high‑strength version of Trelegy Ellipta with a Paragraph IV certification under the Hatch‑Waxman Act. If approved, the application could qualify for 180 days of generic market exclusivity in the United States, subject to FDA approval and potential litigation outcomes.
Trelegy Ellipta is approved in the U.S. for maintenance treatment of asthma in adults aged 18 years and older, as well as for maintenance treatment of chronic obstructive pulmonary disease (COPD). According to IQVIA data cited by the company, the branded product generated approximately $8 billion in U.S. net sales in 2025.
Transpire Bio Chief Executive Officer Dr. Xian‑Ming Zeng said the FDA filing acceptance marks another milestone for the company’s complex generic inhalation portfolio. He noted that Transpire Bio’s generic versions of Breo and Trelegy have both achieved first‑to‑file status, with the latest ANDA potentially representing a third such opportunity. Zeng emphasized the company’s goal of expanding patient access to lower‑cost treatment options for asthma and COPD.
Chief Scientific Officer Dr. Abhishek Gupta highlighted that the filing reflects the company’s capabilities in developing complex drug‑device combination products and underscored the technical and scientific expertise of the development team.
Beyond its complex generics business, Transpire Bio is advancing a pipeline of inhaled therapies for idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF), with three investigational assets currently in development. The company is also developing inhaled therapies targeting pulmonary arterial hypertension (PAH), diabetes, obesity, Parkinson’s disease psychosis, and glioblastoma.
Transpire Bio’s research, development, and manufacturing operations are based in South Florida, United States. Trelegy® Ellipta® is a registered trademark of the GSK plc group of companies.
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About the Writer
Karthik Teja Macharla, PharmD (LinkedIn) is a Pharm.D. graduate with a strong interest in clinical research, pharmacovigilance, and medical writing. In his words, he is passionate about converting complex medical information into clear, evidence-based scientific communication, committed to contributing to patient safety and advancing healthcare through accurate and impactful medical content.
