Prescription medicine
Aclidinium Brand names: Tudorza; first approved as Tudorza Pressair
Aclidinium (Tudorza Pressair) is a prescription medicine with an FDA approval on record since 2012. No generic is listed; pharmacies paid $344.55 per unit (Tudorza pressair 400 mcg inhal) in the October 7, 2026 NADAC survey.
- No generic listed
Check it at the source: the aclidinium FDA label on DailyMed (effective August 1, 2022, Covis Pharma US, Inc); the NDA 202450 record on Drugs@FDA; every aclidinium label on DailyMed.
Highlights of the record
FDA label of August 1, 2022; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageTUDORZA® PRESSAIR® (aclidinium bromide inhalation powder) is 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
- July 23, 2012 Tudorza Pressair, Azurity; Drugs@FDA’s file, where older or withdrawn approvals can be missing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 Tudorza Pressair powder; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $344.55 per unit Tudorza pressair 400 mcg inhal
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 6,373 through July 30, 2026
What is aclidinium used for?
From the label: indications and usageTUDORZA® PRESSAIR® (aclidinium bromide inhalation powder) is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). TUDORZA PRESSAIR is an anticholinergic indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).
Conditions named in the indications of aclidinium's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Anticholinergic.
Source: FDA drug label (Tudorza Pressair), NDA202450 (Azurity), as published by Covis Pharma US, Inc, effective August 1, 2022 (SPL set 6f92cceb-a63f-4470-99b6-56179d98f10f), via openFDA; the full label on DailyMed
Is there a generic for aclidinium (Tudorza Pressair)?
No generic aclidinium is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 2 patents for Tudorza 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.
- 2012 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 do pharmacies pay for aclidinium (Tudorza Pressair)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $344.55 per unit (Tudorza pressair 400 mcg inhal). 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.
- Tudorza pressair 400 mcg inhal (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Tudorza pressair 400 mcg inhal | Brand | $344.55 per unit | 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 do FAERS reports show for aclidinium?
The FDA Adverse Event Reporting System holds 6,373 reports that list aclidinium among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 288 are coded as a death and 1,892 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 aclidinium?
14 other medicines are given the same way (respiratory (inhalation)) and in the same FDA class as aclidinium 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 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 |
| Budesonide and formoterol and glycopyrrolate | COPD | none listed | $61.41 per gram 160-9-4.8 mcg | 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 |
| Formoterol and glycopyrrolate | COPD | none listed | $40.86 per gram Bevespi aerosphere inhaler | No current entry |
| Olodaterol and tiotropium | COPD | none listed | $115.80 per gram 60) | No current entry |
Every medicine labeled for the same conditions as aclidinium
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to aclidinium
- 14 medicines for the same use
- Other anticholinergics
- the pharmacologic class, with prices and generics
- Aclidinium side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other