Yupelri

(Revefenacin)

Small molecule

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

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Clinical

Trials by Indication[1]

COPD3 trials

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

Phase 4 COPD and Suboptimal Inspiratory Flow Rate

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

Revefenacin Peak Inspiratory Flow Rate (PIFR) Study in COPD

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

Regulatory

FDA Approval Timeline[3]

Nov 9, 2018

YUPELRI

NDA NDA210598

Sources

References

[1]
ClinicalTrials.gov — 3 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]
OpenFDA — FDA approval records (NDA NDA210598). U.S. Food & Drug Administration.
[4]
FDA Orange Book — Patent and exclusivity data for Yupelri. U.S. Food & Drug Administration.
[5]
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]
Company: PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Patent Landscape[4]

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