NDAINHALATIONPOWDER, METERED
Approved
Jul 2012
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
20
Data completeness
4/8 — Partial
Drug data last refreshed 42m ago · AI intelligence enriched 42m ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TUDORZA PRESSAIR is an inhaled anticholinergic bronchodilator containing aclidinium bromide, approved in 2012 for maintenance treatment of chronic obstructive pulmonary disease (COPD). It works by blocking muscarinic receptors in airway smooth muscle to improve airflow and reduce symptoms in COPD patients.
$11MPart D
LOE Approaching2.4 years to LOEWith LOE approaching in 2029 and modest Part D utilization (~12K claims), this product is transitioning toward decline, likely consolidating to a smaller, specialized commercial team.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Phase I, Open-Label, Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Aclidinium Bromide in Healthy Chinese Participants
Started Oct 2021
20 enrolled
Healthy Volunteers
To Evaluate Effectiveness of Aclidinium Bromide/Formoterol Fumarate Dihydrate in Chronic Obstructive Pulmonary Disease
Started Dec 2017
0Chronic Obstructive Pulmonary Disease
Pharmacokinetics, Safety and Tolerability of Twice-Daily Aclidinium Bromide/Formoterol Fumarate Fixed Dose Combination in Chinese Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
Started Nov 2017
20 enrolled
Pulmonary Disease, Chronic Obstructive
Aclidinium Bromide Post-Authorisation Safety Study to Evaluate the Risk of Cardiovascular Endpoints
Started Mar 2017
26,839 enrolled
Pulmonary Disease, Chronic Obstructive
Study to Assess Efficacy and Safety of Aclidinium Bromide and Aclidinium Bromide/Formoterol Fumarate in Stabile COPD Patients
Started Feb 2017
1,625 enrolled
COPD
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.