Umeclidinium bromide manufacturers

About umeclidinium bromide

Umeclidinium bromide manufacturers are led by the originator, GSK, which sells it alone as Incruse Ellipta and in combination as Anoro Ellipta and Trelegy Ellipta, while generic developers such as Transpire Bio have filed US applications for generic Trelegy. Umeclidinium is a once-daily long-acting muscarinic antagonist (LAMA) inhaled for chronic obstructive pulmonary disease (COPD). No generic is approved in the US. Pharmaceutical companies can source umeclidinium inhalers and API through development partnerships or out-licensing.

Umeclidinium bromide key facts

Umeclidinium bromide manufacturers and licensing history

GSK developed umeclidinium as a once-daily LAMA for COPD. It was first approved in December 2013 in Anoro Ellipta, combined with vilanterol, and alone as Incruse Ellipta on 30 April 2014. Trelegy Ellipta, a triple combination with fluticasone furoate and vilanterol, followed in 2017 and is now one of the world's largest respiratory products.

No generic umeclidinium product is approved in the US. Transpire Bio has filed what it believes are first-to-file ANDAs for generic Trelegy, including the high-strength version accepted for review in 2026. Several oppositions have been filed against GSK's European patents.

Generic inhalers are complex to develop. Buyers should confirm device design, in vitro equivalence data, GMP status and patent position before choosing a partner.

Umeclidinium bromide dosage forms and dossier types

Umeclidinium is available only in Ellipta dry powder inhalers, alone or in fixed combinations.

Umeclidinium bromide regulatory and patent status

Umeclidinium was first approved in Anoro Ellipta in December 2013, then as Incruse Ellipta on 30 April 2014 and in Trelegy in 2017. No generic is approved in the US. Patent databases estimate Incruse's last US patent expires in October 2030, and generic Trelegy ANDAs are under FDA review. Check the FDA Orange Book and national registers before planning development.

Umeclidinium bromide mechanism of action and therapeutic use

Umeclidinium blocks muscarinic receptors in the airways, which prevents acetylcholine from narrowing them. This keeps the airways open for 24 hours. Umeclidinium is used once daily for maintenance treatment of COPD, alone or with vilanterol and fluticasone furoate. It is not a rescue medicine for sudden breathing problems.

Umeclidinium bromide licensing and sourcing

Umeclidinium 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 umeclidinium bromide manufacturers on Pipelinepharma.

Frequently asked questions about umeclidinium bromide

Who manufactures umeclidinium bromide? GSK makes umeclidinium and sells it in Incruse, Anoro and Trelegy Ellipta. Transpire Bio and others are developing generic versions.

Is there a generic version of umeclidinium? No. No generic umeclidinium product is approved in the US. Generic Trelegy ANDAs are under FDA review.

What forms and strengths of umeclidinium are available? Umeclidinium is available as 62.5 mcg per inhalation in Ellipta inhalers, alone or with vilanterol and fluticasone furoate.

What is umeclidinium used for? Umeclidinium is used once daily for maintenance treatment of COPD.

What is the difference between Incruse, Anoro and Trelegy? Incruse contains umeclidinium alone. Anoro adds vilanterol. Trelegy adds both vilanterol and the inhaled steroid fluticasone furoate.