About arformoterol
Arformoterol manufacturers include the originator Sunovion, now Sumitomo Pharma America (Brovana), and US generic makers Glenmark, Cipla and Lupin. Arformoterol tartrate is a long-acting beta-2 agonist given by nebuliser for the maintenance treatment of chronic obstructive pulmonary disease (COPD). It is the (R,R)-isomer of formoterol. Pharmaceutical companies can source arformoterol inhalation solution through out-licensing, supply or technology transfer. Dossiers are available in US ANDA format.
Arformoterol key facts
|
Property |
Arformoterol |
|---|---|
|
INN |
Arformoterol (as tartrate) |
|
Chemical description |
(R,R)-enantiomer of formoterol |
|
Molecular formula / weight |
C19H24N2O4 / 344.4 g/mol (base) |
|
Drug class |
Long-acting beta-2 adrenergic agonist (LABA) |
|
Brand name |
Brovana (US) |
|
Originator |
Sepracor, later Sunovion; now Sumitomo Pharma America |
|
Dosage form and strength |
Inhalation solution 15 mcg/2 ml, unit-dose vials, for nebuliser use |
|
Dose |
15 mcg twice daily (morning and evening) |
|
Indication |
Long-term maintenance treatment of bronchoconstriction in COPD, including chronic bronchitis and emphysema |
|
First approval |
US FDA, October 2006 |
|
US generics |
Glenmark (June 2021), Cipla (June 2021), Lupin (February 2022), and others |
|
Market size |
Brovana US sales about USD 438 million (IQVIA, 12 months to April 2021) |
|
EU status |
Not approved |
|
Patent status |
Off-patent in the US; generics marketed |
Arformoterol manufacturers and licensing history
Sepracor developed arformoterol as the single active isomer of formoterol, and the FDA approved Brovana in October 2006. Sepracor became Sunovion, now part of Sumitomo Pharma.
The first US generics were approved in June 2021. Glenmark received approval for 15 mcg/2 ml unit-dose vials made at its Monroe, North Carolina site, its first nebuliser approval. Cipla's generic was approved at the same time, and Lupin followed in February 2022. At the time, Brovana had US sales of about USD 438 million a year.
Arformoterol is a sterile nebuliser solution, so manufacturing needs blow-fill-seal or similar aseptic capability. Buyers should confirm GMP status, a US DMF for arformoterol tartrate and sterile manufacturing capacity before choosing a dossier partner.
Arformoterol dosage forms and dossier types
Arformoterol is approved as a 15 mcg/2 ml inhalation solution in unit-dose vials. Generic arformoterol manufacturers develop the same product, referencing Brovana.
|
Form |
Strengths |
Typical dossier |
Notes |
|---|---|---|---|
|
Arformoterol inhalation solution |
15 mcg/2 ml unit-dose vial |
US ANDA |
Main form for licensing; reference Brovana |
|
Arformoterol tartrate API |
Bulk |
US DMF |
Enantiomeric purity is critical |
|
Target market |
Dossier format |
Key requirement |
|---|---|---|
|
United States |
ANDA (eCTD) |
Sterile nebuliser manufacturing; FDA product-specific guidance |
|
Canada, other markets |
National CTD |
Check whether a reference product is authorised |
|
European Union |
Not applicable |
Not approved; formoterol nebuliser products used instead |
Arformoterol regulatory and patent status
The FDA approved Brovana in October 2006. The first generics were approved in June 2021, and several companies now market arformoterol in the US. Arformoterol is not approved in the EU. Like other LABAs, it is for COPD only and is not indicated for asthma or acute bronchospasm.
Arformoterol mechanism of action and therapeutic use
Arformoterol stimulates beta-2 receptors in airway smooth muscle, which relaxes the airways for about 12 hours. It is the active isomer of formoterol. Arformoterol is used twice daily by nebuliser for the long-term maintenance treatment of bronchoconstriction in COPD. It is not a rescue medicine for sudden breathing problems.
Arformoterol licensing and sourcing
Arformoterol suppliers and licensing partners typically offer dossier out-licensing, finished-product supply or technology transfer. Buyers usually compare GMP status (US FDA, EU GMP), sterile manufacturing capability, dossier format and territory availability. Current offers and supplier contacts are listed among the arformoterol manufacturers on Pipelinepharma.
Frequently asked questions about arformoterol
Who are the main arformoterol manufacturers? Sumitomo Pharma America (formerly Sunovion) makes Brovana. US generic arformoterol is made by Glenmark, Cipla, Lupin and others.
Is there a generic version of arformoterol? Yes. The first US generics were approved in June 2021, including Glenmark and Cipla, and Lupin followed in February 2022.
What is the difference between arformoterol and formoterol? Formoterol is a mixture of two mirror-image forms. Arformoterol is the single active (R,R) form.
What forms and strengths of arformoterol are available? Arformoterol is available as a 15 mcg/2 ml inhalation solution in unit-dose vials, for use with a nebuliser.
Is arformoterol approved in the EU? No. Arformoterol is approved in the US but not in the EU.
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