Prescription medicine

Budesonide and formoterol and glycopyrrolate Brand names: Breztri; first approved as Breztri Aerosphere

Budesonide and formoterol and glycopyrrolate (Breztri) is a prescription medicine with an FDA approval on record since 2020. No generic is listed; pharmacies paid $61.41 per gram (Breztri aerosphere 160-9-4.8 mcg) in the October 7, 2026 NADAC survey.

No generic listed

Check it at the source: the budesonide and formoterol and glycopyrrolate FDA label on DailyMed (effective April 27, 2026, AstraZeneca Pharmaceuticals LP); the NDA 212122 record on Drugs@FDA; every budesonide and formoterol and glycopyrrolate label on DailyMed.

Highlights of the record

FDA label of April 27, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026

Used for

From the label: indications and usage
BREZTRI AEROSPHERE is a combination of budesonide, an inhaled corticosteroid (ICS);

Forms and strengths

Aerosol (metered).

On the market

Earliest approval on file: July 23, 2020 Breztri Aerosphere, Astrazeneca Ab; Drugs@FDA’s file, where older or withdrawn approvals can be missing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: October 5, 2038 Breztri Aerosphere aerosol; not a generic launch date

Supply and safety

Pharmacy cost (NADAC): $61.41 per gram Breztri aerosphere 160-9-4.8 mcg
Shortage (FDA): No current entry
Recalls by its makers (FDA): No recall recorded
FAERS reports: 10,386 through July 30, 2026

What is budesonide and formoterol and glycopyrrolate used for?

From the label: indications and usage
BREZTRI AEROSPHERE is a combination of budesonide, an inhaled corticosteroid (ICS); glycopyrrolate, an anticholinergic; and formoterol fumarate, a long-acting beta 2 -adrenergic agonist (LABA), indicated for:
the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients. ( 1.1 )
the maintenance treatment of asthma in adult and pediatric patients 12 years of age and older. ( 1.2 ) Limitations of Use: Not indicated for the relief of acute bronchospasm. […]

Conditions named in the indications of budesonide and formoterol and glycopyrrolate's FDA labels, with every medicine labeled for each:

From other budesonide and formoterol and glycopyrrolate labels
Asthma: Treatment of Asthma BREZTRI AEROSPHERE is indicated for the maintenance treatment of asthma in adult and pediatric patients 12 years of age and older.

FDA pharmacologic class: Anticholinergic, Cholinergic Muscarinic Antagonist, Corticosteroid and beta2-Adrenergic Agonist.

Source: FDA drug label (BREZTRI), AstraZeneca Pharmaceuticals LP, effective April 27, 2026 (SPL set 715433dc-cb2b-43ea-b6df-c5b4177adc6c), via openFDA; the full label on DailyMed

Is there a generic for budesonide and formoterol and glycopyrrolate (Breztri)?

No generic budesonide and formoterol and glycopyrrolate is approved (Drugs@FDA, October 8, 2026).

The Orange Book lists 9 patents for Breztri Aerosphere aerosol, the last expiring on October 5, 2038. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.

2020 earliest approval on file
2038 last listed patent

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What do pharmacies pay for budesonide and formoterol and glycopyrrolate (Breztri)?

In CMS's NADAC survey of October 7, 2026, pharmacies paid $61.41 per gram (Breztri aerosphere 160-9-4.8 mcg). 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.

NADAC per unit, October 7, 2026
Strength and form	Brand or generic	Pharmacy cost	30 tablets, or one pen or vial	12-month change
Breztri aerosphere 160-9-4.8 mcg	Brand	$61.41 per gram	n/a	n/a

Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price

What does the budesonide and formoterol and glycopyrrolate label say about other medicines?

The budesonide and formoterol and glycopyrrolate label names 13 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 -adrenoceptor agonist albuterol, when administered intravenously, have been reported to aggravate preexisting diabetes mellitus and ketoacidosis.
Arformoterol	warnings and precautions	Patients using BREZTRI AEROSPHERE should not use another medicine containing a LABA (e.g., salmeterol, formoterol fumarate, arformoterol tartrate, indacaterol) for any reason [see Drug Interactions (7.1) ].
Atazanavir	drug interactions	Caution should be exercised when considering the coadministration of BREZTRI AEROSPHERE with long-term ketoconazole and other known strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin) [see Warnings and Precautions (5.9) ].
Clarithromycin	drug interactions	Caution should be exercised when considering the coadministration of BREZTRI AEROSPHERE with long-term ketoconazole and other known strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin) [see Warnings and Precautions (5.9) ].
Fluticasone	warnings and precautions	Three trials included adult and adolescent patients aged ≥12 years: one trial compared budesonide/formoterol to budesonide; one trial compared fluticasone propionate/salmeterol inhalation powder to fluticasone propionate inhalation powder; and one trial compared mometasone furoate/formoterol to mometasone furoate.
Itraconazole	drug interactions	Caution should be exercised when considering the coadministration of BREZTRI AEROSPHERE with long-term ketoconazole and other known strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin) [see Warnings and Precautions (5.9) ].
Ketoconazole	drug interactions	After oral administration of ketoconazole, a strong inhibitor of CYP3A4, the mean plasma concentration of orally administered budesonide increased.
Mometasone	warnings and precautions	Three trials included adult and adolescent patients aged ≥12 years: one trial compared budesonide/formoterol to budesonide; one trial compared fluticasone propionate/salmeterol inhalation powder to fluticasone propionate inhalation powder; and one trial compared mometasone furoate/formoterol to mometasone furoate.
Nefazodone	drug interactions	Caution should be exercised when considering the coadministration of BREZTRI AEROSPHERE with long-term ketoconazole and other known strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin) [see Warnings and Precautions (5.9) ].
Nelfinavir	drug interactions	Caution should be exercised when considering the coadministration of BREZTRI AEROSPHERE with long-term ketoconazole and other known strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin) [see Warnings and Precautions (5.9) ].
Prednisone	warnings and precautions	Patients who have been previously maintained on 20 mg or more per day of prednisone (or its equivalent) may be most susceptible, particularly when their systemic corticosteroids have been almost completely withdrawn.
Ritonavir	drug interactions	Strong cytochrome P450 3A4 inhibitors (e.g. ritonavir): Use with caution.
Salmeterol	warnings and precautions	Salmeterol Multicenter Asthma Research Trial (SMART) A 28-week, placebo-controlled U.S. trial that compared the safety of salmeterol with placebo, each added to usual asthma therapy, showed an increase in asthma-related deaths in patients receiving salmeterol (13/13,176 in patients treated with salmeterol vs. …

Check budesonide and formoterol and glycopyrrolate against other medicines

Source: FDA drug label (BREZTRI), AstraZeneca Pharmaceuticals LP, effective April 27, 2026 (SPL set 715433dc-cb2b-43ea-b6df-c5b4177adc6c), via openFDA; the full label on DailyMed

What do FAERS reports show for budesonide and formoterol and glycopyrrolate?

The FDA Adverse Event Reporting System holds 10,386 reports that list budesonide and formoterol and glycopyrrolate among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,280 are coded as a death and 1,379 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 rose sharply in 2025 (3,164, against a median of 80 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.

Reports received each year

The most reported reactions

Dyspnoea2,012
Device Delivery System Issue1,579
Product Dose Omission Issue (a use or a product term, not a reaction)1,464
Wrong Technique In Device Usage Process (a use or a product term, not a reaction)1,166
Death (an outcome recorded in the report)1,140
Device Use Issue1,089
Cough (named in the label)839
Device Malfunction822

Side effects: the label's list and every FAERS reaction

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What else is labeled for the same conditions as budesonide and formoterol and glycopyrrolate?

17 other medicines are given the same way (respiratory (inhalation)) and in the same FDA class as budesonide and 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
Albuterol	Asthma	33 labelers	$0.0612 per mL 2.5 mg/3 mL solution	Resolved
Fluticasone and salmeterol	Asthma, COPD	8 labelers	$1.07 per unit 100-50	A presentation being discontinued
Fluticasone	Asthma	1 labeler	$11.82 per gram 44 mcg inhaler	No current entry
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
Beclomethasone	Asthma	2 labelers	$20.57 per gram 40 mcg	No current entry
Fluticasone and vilanterol	Asthma, COPD	none listed	$3.90 per unit 100-25	No current entry

Every medicine labeled for the same conditions as budesonide and formoterol and glycopyrrolate

Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)

What next?

Alternatives to budesonide and formoterol and glycopyrrolate: 17 medicines for the same use
Other anticholinergics: the pharmacologic class, with prices and generics
Budesonide and formoterol and glycopyrrolate side effects: the label's list beside FAERS reports
Check an interaction: what two or more labels say about each other