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Colazal

(Balsalazide)

Small molecule

VValeant Pharmaceuticals

0

Indications

2

Total Trials

0

Active Trials

0

Competitors

2

FDA Applications

NDA/BLA/ANDA regulatory filings

6

Patents

Clinical

Trials by Indication[1]

Fasting Conditions2 trials

Bioequivalency Study of Balsalazide Capsules Under Fasting Conditions

Completed·RRoxane Laboratories·N/A·NCT00618228·52 enrolled

A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Balsalazide Disodium 750 mg Capsules Under Fasting Conditions

Completed·RRoxane Laboratories·N/A·NCT00618202·52 enrolled

Regulatory

FDA Approval Timeline[3]

Jul 18, 2000

COLAZAL

NDA NDA020610

Feb 3, 2012

GIAZO

NDA NDA022205

Sources

References

[1]
ClinicalTrials.gov — 2 trial records for Balsalazide. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Balsalazide compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
OpenFDA — FDA approval records (NDA NDA022205). U.S. Food & Drug Administration.
[4]
FDA Orange Book — Patent and exclusivity data for Colazal. U.S. Food & Drug Administration.
[5]
SEC EDGAR — Valeant Pharmaceuticals company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Company: VValeant Pharmaceuticals

Patent Landscape[4]

Patent Cliff

Aug 2, 2026

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9192616Aug 2, 2026

7625884Aug 24, 2026

7452872Aug 24, 2026

7452872*PEDFeb 24, 2027

7625884*PEDFeb 24, 2027

1 more patents

8497256Jun 23, 2031

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