Transpire Bio recently announced that its Abbreviated New Drug Application (ANDA) for fluticasone furoate, umeclidinium, and vilanterol inhalation powder, a generic version of the high-strength Trelegy Ellipta (200 mcg/62.5 mcg/25 mcg) product, has been accepted for filing by the US Food and Drug Administration (FDA).

Based on the FDA's public records, 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 the company’s ANDA be approved by the FDA, it believes it will be eligible for 180 days of market exclusivity.

In the US, 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 US annual sales of USD 8 billion in 2025.

Dr. Xian-Ming Zeng, Chief Executive Officer (CEO), Transpire Bio, said, "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. 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."

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. It 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 the company's state-of-the-art manufacturing facilities located in South Florida, U.S.

Dr. Abhishek Gupta, Chief Scientific Officer, Transpire Bio, said, "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."