ATROVENT
LOE ApproachingNDAINHALATIONSOLUTIONPriority Review
Approved
Sep 1993
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
17
Data completeness
3/8 — Basic
Priority Review
ATROVENT by Boehringer Ingelheim is (parasympatholytic) agent which, based on animal studies, appears to inhibit vagally-mediated reflexes by antagonizing the action of acetylcholine, the transmitter agent released at the neuromuscular junctions in the lung. First approved in 1993.
Drug data last refreshed 11h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ATROVENT is an inhaled anticholinergic (parasympatholytic) agent that blocks vagally-mediated airway reflexes by antagonizing acetylcholine at muscarinic receptors on bronchial smooth muscle. It reduces intracellular calcium concentration to prevent bronchoconstriction. The drug is indicated for maintenance treatment of airway obstruction in patients with chronic obstructive pulmonary disease (COPD) and asthma.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30/100), signaling team downsizing and transition planning ahead.
Mechanism of Action
(parasympatholytic) agent which, based on animal studies, appears to inhibit vagally-mediated reflexes by antagonizing the action of acetylcholine, the transmitter agent released at the neuromuscular junctions in the lung. Anticholinergics prevent the increases in intracellular concentration of…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (17)
A Comparison of 18g of Tiotropium Inhalation Capsules Once Daily and Atrovent Metered Dose Inhaler (2 Puffs of 20g, 4 Times Daily) in a Double-Blind, Double-Dummy, Efficacy and Safety Study in Adults With Chronic Obstructive Pulmonary Disease (COPD)
Started Jun 2003
200 enrolled
Pulmonary Disease, Chronic Obstructive
Safety Trial of Atrovent® in Pediatric Patients With Rhinorrhea Associated With a Common Cold or Allergy
Started Dec 2002
230 enrolled
Cold
Acute Bronchodilator Response of a Single Dose of Atrovent or Berotec on Top of Pharmacodynamic Steady State of Spiriva
Started Oct 2002
65 enrolled
Pulmonary Disease, Chronic Obstructive
Efficacy and Safety of Tiotropium Inhalation Capsules and Atrovent MDI in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Started Sep 2002
132 enrolled
Pulmonary Disease, Chronic Obstructive
Comparison of Tiotropium Inhalation Capsules and Atrovent Metered Dose Inhaler (MDI) in a Efficacy and Safety Study in Adults With Chronic Obstructive Pulmonary Disease
Started Jun 2001
50 enrolled
Pulmonary Disease, Chronic Obstructive
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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.