NDAORALCAPSULE
Approved
Jul 2000
Lifecycle
LOE Approaching
Competitive Pressure
25/100
Clinical Trials
2
Data completeness
6/8 — Strong
COLAZAL (balsalazide disodium) by Bausch + Lomb is mesalamine, which is the therapeutically active portion of the molecule, and the 4-aminobenzoyl-β-alanine carrier moiety. Approved for ulcerative colitis, inflammatory bowel disease. First approved in 2000.
Drug data last refreshed 18h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
COLAZAL is an oral small-molecule 5-aminosalicylate (5-ASA) prodrug approved for ulcerative colitis and inflammatory bowel disease. Balsalazide disodium is cleaved in the colon to release mesalamine, which reduces inflammation by inhibiting arachidonic acid metabolites (prostanoids and leukotrienes). The mechanism is believed to be local to the colonic mucosa rather than systemic.
$0.197MPart D
LOE ApproachingDeclining
10mo to LOEMature product facing imminent loss of exclusivity with minimal Part D volume; brand team focus is on profitability preservation rather than growth initiatives.
Mechanism of Action
mesalamine, which is the therapeutically active portion of the molecule, and the 4-aminobenzoyl-β-alanine carrier moiety. The carrier moiety released when balsalazide disodium is cleaved is only minimally absorbed and is largely inert. The mechanism of action of 5-ASA is unknown, but appears to be…
Indications (2)
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.