Prescription medicine
Aclidinium and formoterol Brand names: Duaklir; first approved as Duaklir Pressair
Aclidinium and formoterol (Duaklir Pressair) is a prescription medicine with an FDA approval on record since 2019. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the aclidinium and formoterol FDA label on DailyMed (effective August 1, 2022, Covis Pharma US, Inc); the NDA 210595 record on Drugs@FDA; every aclidinium and formoterol label on DailyMed.
Highlights of the record
FDA label of August 1, 2022; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageDUAKLIR PRESSAIR is a combination of aclidinium bromide (an anticholinergic) and formoterol fumarate (a LABA) indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).
Forms and strengths
Powder (metered).
On the market
- Earliest approval on file
- March 29, 2019 Duaklir Pressair, Azurity; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- March 13, 2029 Duaklir Pressair powder; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 29 through July 30, 2026
What is aclidinium and formoterol used for?
From the label: indications and usageDUAKLIR PRESSAIR is a combination of aclidinium bromide (an anticholinergic) and formoterol fumarate (a LABA) indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Limitations of Use: DUAKLIR PRESSAIR is not indicated for the relief of acute bronchospasm or for the treatment of asthma [see Warnings and Precautions ( 5.1 , 5.4 )]. DUAKLIR PRESSAIR is a combination of aclidinium bromide an anticholinergic, and formoterol fumarate, a long-acting beta 2 -adrenergic agonist (LABA) indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). […]
Conditions named in the indications of aclidinium and formoterol's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Anticholinergic and beta2-Adrenergic Agonist.
Source: FDA drug label (DUAKLIR PRESSAIR), NDA210595 (Azurity), as published by Covis Pharma US, Inc, effective August 1, 2022 (SPL set 2eba3089-28b4-4190-9fba-2511246cfd16), via openFDA; the full label on DailyMed
Is there a generic for aclidinium and formoterol (Duaklir Pressair)?
No generic aclidinium and formoterol is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 2 patents for Duaklir Pressair powder, the last expiring on March 13, 2029. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2019 earliest approval on file
- 2029 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the aclidinium and formoterol label say about other medicines?
The aclidinium and formoterol label names 2 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Albuterol | warnings and precautions | Doses of the related beta-agonist albuterol, when administered intravenously, have been reported to aggravate pre-existing diabetes mellitus and ketoacidosis. |
| Salmeterol | warnings and precautions | A 28-week, placebo-controlled, U.S. trial comparing the safety of another LABA (salmeterol) with placebo, each added to usual asthma therapy, showed an increase in asthma-related deaths in subjects receiving salmeterol (13/13,176 in subjects treated with salmeterol vs 3/13,179 in subjects treated with placebo; … |
Source: FDA drug label (DUAKLIR PRESSAIR), NDA210595 (Azurity), as published by Covis Pharma US, Inc, effective August 1, 2022 (SPL set 2eba3089-28b4-4190-9fba-2511246cfd16), via openFDA; the full label on DailyMed
What do FAERS reports show for aclidinium and formoterol?
The FDA Adverse Event Reporting System holds 29 reports that list aclidinium and formoterol among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1 are coded as a death and 4 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as aclidinium and formoterol?
12 other medicines are given the same way (respiratory (inhalation)) and in the same FDA class as aclidinium and formoterol or labeled mainly for the same use (COPD), the same class first. COPD lists all 23 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (respiratory (inhalation)) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Fluticasone and salmeterol | COPD | 8 labelers | $1.07 per unit 100-50 | A presentation being discontinued |
| Albuterol and ipratropium | COPD | 14 labelers | $0.0787 per mL 0.5-3(2.5) mg/3 mL | No current entry |
| Ipratropium | COPD | 13 labelers | $0.111 per mL 0.02% solution | No current entry |
| Arformoterol | COPD | 15 labelers | $0.633 per mL 15 mcg/2 mL solution | No current entry |
| Fluticasone and vilanterol | COPD | none listed | $3.90 per unit 100-25 | No current entry |
| Fluticasone and umeclidinium and vilanterol | COPD | none listed | $11.12 per unit 100-62.5-25 | No current entry |
| Tiotropium | COPD | none listed | $126.08 per gram 1.25 mcg inhaler | No current entry |
| Umeclidinium and vilanterol | COPD | none listed | $4.95 per inhaler 62.5-25 mcg inhaler | No current entry |
Every medicine labeled for the same conditions as aclidinium and formoterol
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to aclidinium and formoterol
- 12 medicines for the same use
- Other anticholinergics
- the pharmacologic class, with prices and generics
- Aclidinium and formoterol side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other