Prescription medicine
Formoterol and glycopyrrolate Brand names: Bevespi; first approved as Bevespi Aerosphere
Formoterol and glycopyrrolate (Bevespi) is a prescription medicine with an FDA approval on record since 2016. No generic is listed; pharmacies paid $40.86 per gram (Bevespi aerosphere inhaler) in the October 7, 2026 NADAC survey.
- No generic listed
Check it at the source: the formoterol and glycopyrrolate FDA label on DailyMed (effective March 24, 2023, AstraZeneca Pharmaceuticals LP); the NDA 208294 record on Drugs@FDA; every formoterol and glycopyrrolate label on DailyMed.
Highlights of the record
FDA label of March 24, 2023; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageBEVESPI AEROSPHERE is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).
Forms and strengths
Aerosol (metered).
On the market
- Earliest approval on file
- April 25, 2016 Bevespi Aerosphere, Astrazeneca; Drugs@FDA’s file, where older or withdrawn approvals can be missing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 17, 2031 Bevespi Aerosphere aerosol; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $40.86 per gram Bevespi aerosphere inhaler
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2021 0 Class I among all firms' recalls; latest March 15, 2021
- FAERS reports
- 1,941 through July 30, 2026
What is formoterol and glycopyrrolate used for?
From the label: indications and usageBEVESPI AEROSPHERE is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Limitations of Use: BEVESPI AEROSPHERE is not indicated for the relief of acute bronchospasm or for the treatment of asthma [see Warnings and Precautions ( 5.1 , 5.2 )]. BEVESPI AEROSPHERE is a combination of glycopyrrolate, 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). ( 1 ) Limitations of Use: Not indicated for the relief of acute bronchospasm or for the treatment of asthma.
Conditions named in the indications of formoterol and glycopyrrolate's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Anticholinergic, Cholinergic Muscarinic Antagonist and beta2-Adrenergic Agonist.
Source: FDA drug label (BEVESPI AEROSPHERE), AstraZeneca Pharmaceuticals LP, effective March 24, 2023 (SPL set ae02436e-9528-490e-a844-0c0f6f2843f9), via openFDA; the full label on DailyMed
Is there a generic for formoterol and glycopyrrolate (Bevespi)?
No generic formoterol and glycopyrrolate is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 7 patents for Bevespi Aerosphere aerosol, the last expiring on March 17, 2031. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2016 earliest approval on file
- 2031 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for formoterol and glycopyrrolate (Bevespi)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $40.86 per gram (Bevespi aerosphere inhaler), up 3% from $39.78 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Bevespi aerosphere inhaler (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Bevespi aerosphere inhaler | Brand | $40.86 per gram | n/a | +3% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has formoterol and glycopyrrolate been recalled?
The FDA's Enforcement Report lists 1 recall naming formoterol and glycopyrrolate since 2021: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| March 15, 2021 | Class II | Cardinal Health Inc. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the formoterol and glycopyrrolate label say about other medicines?
The formoterol and glycopyrrolate 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 2 -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 US 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 (BEVESPI AEROSPHERE), AstraZeneca Pharmaceuticals LP, effective March 24, 2023 (SPL set ae02436e-9528-490e-a844-0c0f6f2843f9), via openFDA; the full label on DailyMed
What do FAERS reports show for formoterol and glycopyrrolate?
The FDA Adverse Event Reporting System holds 1,941 reports that list formoterol and glycopyrrolate among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 232 are coded as a death and 279 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.
Reports received each year
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 formoterol and glycopyrrolate?
13 other medicines are given the same way (respiratory (inhalation)) and in the same FDA class as formoterol and glycopyrrolate 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 formoterol and glycopyrrolate
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to formoterol and glycopyrrolate
- 13 medicines for the same use
- Other anticholinergics
- the pharmacologic class, with prices and generics
- Formoterol and glycopyrrolate side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other