Yupelri

(Revefenacin)

ApprovedSmall molecule

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

Yupelri is one of 5 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

4 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

2 4

Formoterol Fumarate

AstraZeneca

Phase 3

1 5

Glucophage

EMD Serono

Phase 1

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

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

Revefenacin Peak Inspiratory Flow Rate (PIFR) Study in COPD

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