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Transpire Bio’s Generic Trelegy ANDA Accepted by US FDA

29 Jan 2026
Admin
News Article

Transpire Bio’s Generic Trelegy ANDA Accepted by US FDA

Transpire Bio has announced that the US Food and Drug Administration (FDA) has accepted for filing its abbreviated new drug application (ANDA) for fluticasone furoate, umeclidinium, and vilanterol inhalation powder.

The product is a generic version of Trelegy Ellipta 100/62.5/25, a widely used triple-combination inhaler for asthma and chronic obstructive pulmonary disease (COPD).

Potential first-to-file status under Hatch-Waxman

Based on FDA public records, Transpire Bio believes it is the first company to submit an ANDA with a Paragraph IV certification for this reference listed drug. If confirmed, this status could make Transpire Bio eligible for:

180 days of market exclusivity in the US
Early commercial entry ahead of other generic competitors

Trelegy Ellipta generated nearly $2.7 billion in US net sales in 2024, highlighting the commercial significance of a generic alternative.

Indications and market relevance

In the US, Trelegy Ellipta is approved for:

Maintenance treatment of asthma in adults aged 18 years and older
Maintenance treatment of chronic obstructive pulmonary disease (COPD)

A generic version could substantially improve affordability and access for patients managing chronic respiratory disease.

Company perspective

Dr. Xian-Ming Zeng, CEO of Transpire Bio, said the filing acceptance represents another major milestone in advancing the company’s complex generics franchise and moves the company closer to delivering a more affordable option for asthma and COPD patients.

Dr. Abhishek Gupta, chief scientific officer, added that the milestone reflects Transpire Bio’s scientific and technical strength in developing complex drug-device combination products.

Beyond generics: expanding inhalation pipeline

Alongside its generic portfolio, Transpire Bio is building a pipeline of innovative inhaled therapies, including:

Three development-stage assets for idiopathic pulmonary fibrosis (IPF)
Programs in pulmonary arterial hypertension (PAH)
Additional development efforts in diabetes, obesity, and neurological diseases

All products are being developed and manufactured at the company’s state-of-the-art facilities in South Florida, US.