TheraRadar
Data updated: May 26, 2026

YUPELRI (revefenacin)

Cholinergic Antagonists Trial Activity: Declining
Respiratory Approved 2018-11-09

Yupelri is a long-acting medication used for the daily maintenance of chronic obstructive pulmonary disease (COPD). It helps patients with this condition by providing ongoing support to keep the airways open and improve breathing. This anticholinergic therapy is prescribed as a regular treatment to help manage the persistent respiratory symptoms associated with chronic lung disease.

Source: FDA Label • Viatris • Anticholinergic

How YUPELRI Works

This medication works by blocking M3 receptors found in the smooth muscles of the airways. By inhibiting these receptors, the drug relaxes the muscles and causes bronchodilation, which helps prevent the lungs from tightening. This site-specific effect is long-lasting, providing relief from airway constriction for more than 24 hours.

Development Insights

Mylan Inc. conducting 2 trials (67%)
4 indications explored (Focused)
chronic obstructive pulmonary disease (1 trials)
chronic obstructive pulmonary disease, copd (1 trials)
low peak inspiratory flow rate (pifr) (1 trials)
1
Indication
--
Phase 3 Trials
7
Years on Market

Details

Status
Prescription
First Approved
2018-11-09
Patent Cliff
2039

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Patent cliff and revenue data

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Routes
INHALATION
Dosage Forms
SOLUTION

Companies

Active Ingredient: REVEFENACIN

YUPELRI Approval History

2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
4 FDA actions from 2018 to 2022
May 2022 SUPPL
Label · Labeling
Nov 2021 SUPPL
Label · Labeling
May 2019 SUPPL
Label · Labeling

What YUPELRI Treats

1 indications

YUPELRI is approved for 1 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Chronic Obstructive Pulmonary Disease
Source: FDA Label

YUPELRI Competitive Set

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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to YUPELRI

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FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

ANORO ELLIPTA
UMECLIDINIUM BROMIDE
1 shared
GSK
ARFORMOTEROL TARTRATE
ARFORMOTEROL TARTRATE
1 shared
AIPING PHARM INC
ATROVENT HFA
IPRATROPIUM BROMIDE
1 shared
Boehringer Ingelheim
📋

Clinical Trial Registry

3 trials
Trial Sponsor ID Phase Status Title
NCT05165485 PIFR-2 results posted 0180 Ph 4 completed Phase 4 COPD and Suboptimal Inspiratory Flow Rate
NCT03095456 results posted 0149 Ph 3 completed Revefenacin Peak Inspiratory Flow Rate (PIFR) Study in COPD
NCT03573817 results posted 0167 Ph 3 completed A 42-day Parallel Group Safety Study of Revefenacin and Formoterol, Administered in Sequence and as a Combination, in Participants With COPD
🔬

Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

YUPELRI FDA Label Details

Indications & Usage

FDA Label (PDF)

YUPELRI is indicated for the treatment of Chronic Obstructive Pulmonary Disease.

View full patent landscape →
10 OB patents · 3 families · 162 international docs across 32 countries

YUPELRI Patents & Exclusivity

Latest Patent: Oct 2039

Patents (10 active)

US11484531 Expires Oct 23, 2039
US12285417 Expires Aug 29, 2039
US12048692 Expires Aug 29, 2039
US8541451 Expires Aug 25, 2031
US11008289 Expires Jul 14, 2030
US11858898 Expires Jul 14, 2030
US10550081 Expires Jul 14, 2030
US9765028 Expires Jul 14, 2030
US11691948 Expires Jul 14, 2030
US7288657 Expires Oct 31, 2028
Source: FDA Orange Book

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Deep insights for YUPELRI

Revenue Insights

  • Quarterly revenue tracking
  • Historical trend analysis

Patent Timeline

  • Cliff: 2039
  • 10 active patents

Trial Analysis

  • 3 total trials
  • Stage: Declining

Competitive Landscape

  • 20 similar drugs
  • Same target/indication analysis
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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment