Vilanterol manufacturers

About vilanterol

Vilanterol manufacturers are led by the originator, GSK, which uses it in three Ellipta inhalers: Breo (Relvar in the EU), Anoro and Trelegy. Generic developers such as Transpire Bio have filed US applications for generic Breo and Trelegy. Vilanterol is a once-daily long-acting beta-2 agonist (LABA) for asthma and chronic obstructive pulmonary disease (COPD). It is not sold on its own. Pharmaceutical companies can source vilanterol combination inhalers and API through development partnerships or out-licensing.

Vilanterol key facts

Vilanterol manufacturers and licensing history

GSK developed vilanterol with Theravance as a once-daily LABA. It was approved in 2013 as part of Breo Ellipta (Relvar in the EU), combined with the inhaled steroid fluticasone furoate, and in Anoro Ellipta, combined with umeclidinium. Trelegy Ellipta, a triple inhaler with all three ingredients, followed in 2017.

Trelegy has become one of the world's largest respiratory products, with US sales of about USD 8 billion in 2025. An authorised generic of Breo Ellipta has been available in the US since 2022.

Transpire Bio has filed what it believes are first-to-file ANDAs for generic Breo and Trelegy, and in 2026 its ANDA for high-strength Trelegy was accepted for review. Generic inhalers are complex to develop. Buyers should confirm device design, in vitro equivalence data, GMP status and patent position before choosing a partner.

Vilanterol dosage forms and dossier types

Vilanterol is available only in Ellipta dry powder inhalers, in fixed combinations.

Vilanterol regulatory and patent status

Vilanterol was first approved in Breo Ellipta in 2013, followed by Anoro and Trelegy. An authorised generic of Breo is sold in the US. Generic ANDAs for Breo and Trelegy have been filed with paragraph IV certifications, so launch timing depends on litigation and FDA review. Check the FDA Orange Book and national registers before planning development.

Vilanterol mechanism of action and therapeutic use

Vilanterol stimulates beta-2 receptors in the airways, relaxing the muscles and opening the airways for 24 hours. It is used once daily, always with an inhaled steroid or an anticholinergic, for maintenance treatment of COPD and, in some combinations, asthma. Vilanterol is not used alone in asthma, because LABAs without a steroid increase asthma risks.

Vilanterol licensing and sourcing

Vilanterol suppliers and licensing partners typically offer generic inhaler development, API supply or co-development. Buyers usually compare device capability, GMP status, regulatory progress and patent position. Current offers and supplier contacts are listed among the vilanterol manufacturers on Pipelinepharma.

Frequently asked questions about vilanterol

Who manufactures vilanterol? GSK makes vilanterol and uses it in Breo / Relvar, Anoro and Trelegy Ellipta. Transpire Bio and others are developing generic versions.

Is vilanterol available on its own? No. Vilanterol is sold only in combination inhalers with fluticasone furoate, umeclidinium, or both.

Is there a generic version of vilanterol? An authorised generic of Breo Ellipta has been available in the US since 2022. ANDAs for generic Breo and Trelegy have been filed but depend on FDA review and litigation.

What forms and strengths of vilanterol are available? Vilanterol is available at 25 mcg per inhalation in Ellipta dry powder inhalers, combined with other drugs.

What is vilanterol used for? Vilanterol is used in combination inhalers for maintenance treatment of COPD and, in some products, asthma.