Yupelri

(Revefenacin)

ApprovedSmall molecule

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Yupelri is one of 3 small molecule programs targeting COPD Exacerbation. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

COPD ExacerbationCompleted

COPD ExacerbationApproved

Completed

Competition

Competitive Landscape

2 competitors in COPD Exacerbation

#DrugCompanyPhaseTrials

Atrovent

Boehringer Ingelheim

Approved

1 2

Lipitor

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Approved

1 3

Yupelri

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Approved

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2028

ApprovedNot yet recruiting

COPD Exacerbation

NCT07721922

Clinical

Trials by Indication[1]

COPD3 trials

Revefenacin Peak Inspiratory Flow Rate (PIFR) Study in COPD

Completed·MMylan Inc.·Phase 3·NCT03095456·207 enrolled

Phase 4 COPD and Suboptimal Inspiratory Flow Rate

Completed·TTheravance Biopharma·Phase 4·NCT05165485·404 enrolled

A 42-day Parallel Group Safety Study of Revefenacin and Formoterol, Administered in Sequence and as a Combination, in Participants With COPD

Completed·MMylan Inc.·Phase 3·NCT03573817·122 enrolled

COPD Exacerbation2 trials

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): A Phase IV, Prospective, Randomized, Blinded, Parallel-group Trial

Not yet recruiting·UUniversity of Tennessee Graduate School of Medicine·Approved·NCT07721922·280 enrolled

Randomized, Parallel-group Trial to Evaluate Feasibility, Safety and Efficacy of Nebulized Long-Acting Bronchodilators (Formoterol and Revefenacin) vs. Short-Acting Bronchodilators (Albuterol and Ipratropium) in Hospitalized Patients With AECOPD

Completed·UUniversity of Tennessee Graduate School of Medicine·Approved·NCT04655170·60 enrolled

Regulatory

FDA Approval Timeline[4]

Nov 9, 2018

YUPELRI

NDA NDA210598

Sources

References

[1]
ClinicalTrials.gov — 5 trial records for Revefenacin. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Revefenacin compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Revefenacin. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA210598). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Yupelri. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Pfizer's Upjohn has merged with Mylan to form Viatris Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Patent Landscape[5]

Patent Cliff

Oct 31, 2028

Earliest patent expiration — generic entry possible after this date

Patent #Expires

7288657Oct 31, 2028

10550081Jul 14, 2030

11008289Jul 14, 2030

11858898Jul 14, 2030

9765028Jul 14, 2030

5 more patents

11691948Jul 14, 2030

8541451Aug 25, 2031

12048692Aug 29, 2039

12285417Aug 29, 2039

11484531Oct 23, 2039

Yupelri

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2028

Trials by Indication[1]

COPD3 trials

COPD Exacerbation2 trials

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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