Clinical-stage biopharmaceutical company Transpire Bio Inc announced on Monday 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).

Transpire Bio says that based on the FDA's public records, it 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 United States, 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 recorded US annual sales of USD8bn in 2025.