Transpire Bio has announced the FDA’s acceptance of the company’s ANDA for a generic version of GSK’s Trelegy Ellipta fluticasone furoate / umeclidinium / vilanterol dry powder inhaler. The company says that it believes that it is first to file with a Paragraph IV certification, which would make it eligible for a period of market exclusivity.
The FDA approved Trelegy Ellipta for the treatment of COPD in September 2017 and approved expanded use of the inhaler for COPD in April 2018. In 2020, the FDA okayed the use of Trelegy Ellipta for the treatment of asthma.
In September 2025, Transpire announced that the FDA had accepted its ANDA for a generic of Breo Ellipta fluticasone furoate / vilanterol DPI. The company is developing a number of other inhaled products and announced in June 2025 that it had licensed Suzhou Intragrand Pharma’s ITG-1052 PDE4 inhibitor. Transpire also recently announced the initiation of a Phase 1 trial of an inhaled cannabidiol formulation.
Transpire Bio CEO Xian-Ming Zeng commented, “The FDA’s acceptance for filing of our ANDA for fluticasone furoate, umeclidinium, and vilanterol inhalation powder, a generic version of Trelegy Ellipta, is another major milestone in advancing our complex generic franchise. Our highly experienced team in South Florida continues to work tirelessly to achieve important milestones like this. We are now one step closer to providing patients suffering from asthma or COPD with an affordable option and improved access to this critical medication.”
Chief Scientific Officer Abhishek Gupta said, “This milestone is a result of Transpire Bio’s deep scientific and technical competence, and demonstrates Transpire Bio’s strong capabilities in developing complex drug device combination products.”
Read the Transpire Bio press release
