NDAINHALATIONSOLUTION
Approved
Nov 2018
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
7
Data completeness
5/8 — Partial
YUPELRI (revefenacin) by Viatris is cholinergic antagonists [moa]. First approved in 2018.
Drug data last refreshed 12h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
YUPELRI (revefenacin) is an inhaled anticholinergic agent approved in November 2018 for maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). It works as a cholinergic antagonist to relax airway smooth muscle and improve airflow. Administered as an inhalation solution, it represents a long-acting maintenance therapy for COPD patients.
$4MPart D
Peak13.0 years to LOEProduct is in peak revenue phase with modest Part D penetration; commercial team focus is on defending market share and optimizing managed care access.
Mechanism of Action
Cholinergic Antagonists
Pharmacologic Class:
Anticholinergic
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (7)
Efficacy of Nebulized Long-Acting Bronchodilators (Formoterol and Revefenacin) vs. Short-Acting Bronchodilators (Albuterol and Ipratropium) in Patients Presenting to the Emergency Department With Acute Exacerbation of COPD (ECOPD)
Started Nov 2026
280 enrolled
COPD Exacerbation
Revefenacin in Chinese Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease(COPD)
Started Nov 2021
258 enrolled
COPD
Fasting Bioavailability Study of Mylan's Revefenacin Inhalation Solution
Started Sep 2021
24 enrolled
Healthy Volunteers Bioavailability Study
Feasibility, Safety and Efficacy of Nebulized Long-Acting Bronchodilators (Formoterol and Revefenacin) vs. Short-Acting Bronchodilators (Albuterol and Ipratropium) in Hospitalized Patients With AECOPD
Started Dec 2020
60 enrolled
COPD Exacerbation
Revefenacin in Acute Respiratory Insufficiency in COPD
Started Nov 2020
21 enrolled
COPDAcute Respiratory Failure
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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.