NDAORALCAPSULEPriority Review
Approved
Jul 1990
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
5/8 — Partial
Priority Review
DIPENTUM (olsalazine sodium) by Viatris (2) is colon, colonic bacteria convert olsalazine into 5‑aminosalicylic acid (5-asa or mesalazine). Approved for ulcerative colitis. First approved in 1990.
Drug data last refreshed Yesterday · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DIPENTUM (olsalazine sodium) is an oral small-molecule prodrug that is converted by colonic bacteria into 5-aminosalicylic acid (5-ASA), a topical anti-inflammatory agent for treating ulcerative colitis. The mechanism involves blocking cyclooxygenase and inhibiting prostaglandin production in the colon to reduce inflammation of the colonic epithelium.
$3.0MPart D
LOE ApproachingDeclining
As a mature product approaching loss of exclusivity with limited Part D volume, brand teams typically focus on retention and cost management rather than expansion.
Mechanism of Action
colon, colonic bacteria convert olsalazine into 5‑aminosalicylic acid (5-ASA or mesalazine). The mechanism of action of 5-ASA (mesalamine) is not fully understood, but appears to be a topical anti-inflammatory effect on colonic epithelial cells. Mucosal production of arachidonic acid metabolites,…
Indications (1)
Career Relevance
DIPENTUM recruitment is minimal, reflecting its mature lifecycle and declining market presence. Career opportunities are largely limited to small legacy brand support teams focused on patient retention and managed care negotiations rather than growth initiatives.
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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.