Tudorza Pressair

(Aclidinium)

Small molecule

AAzurity Pharmaceuticals

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Clinical

Trials by Indication[1]

Efficacy and Safety2 trials

Efficacy and Safety Study of Two Fixed-dose Combinations of Aclidinium Bromide With Formoterol Fumarate Compared With Aclidinium Bromide, Formoterol Fumarate and Placebo

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT01049360·128 enrolled

Efficacy and Safety of Two Fixed Dose Combinations of Aclidinium Bromide With Formoterol Fumarate

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT01078623·176 enrolled

Moderate to Severe COPD1 trial

A Dose-Range Finding Study of SUN-101 in Subjects With Moderate to Severe COPD

Completed·SSunovion Respiratory Development Inc.·Phase 2·NCT02038829·96 enrolled

Scar1 trial

Evaluation of Long-Acting Muscarinic Antagonists in COPD

Completed·UUniversity of Dundee·Phase 4·NCT02039050·15 enrolled

Regulatory

FDA Approval Timeline[3]

Jan 1, 1982

QUARZAN

NDA NDA010355

Jul 23, 2012

TUDORZA PRESSAIR

NDA NDA202450

Sources

References

[1]
ClinicalTrials.gov — 4 trial records for Aclidinium. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Aclidinium compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
OpenFDA — FDA approval records (NDA NDA202450). U.S. Food & Drug Administration.
[4]
FDA Orange Book — Patent and exclusivity data for Tudorza Pressair. U.S. Food & Drug Administration.
[5]
SEC EDGAR — Azurity Pharmaceuticals company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Company: AAzurity Pharmaceuticals

Patent Landscape[4]

Patent Cliff

Mar 13, 2029

Earliest patent expiration — generic entry possible after this date

Patent #Expires

10085974Mar 13, 2029