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 8h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DIPENTUM (olsalazine sodium) is an oral capsule small-molecule prodrug approved in 1990 for ulcerative colitis. It is metabolized by colonic bacteria into 5-aminosalicylic acid (5-ASA), which exerts topical anti-inflammatory effects by inhibiting prostaglandin production and arachidonic acid metabolism in the colon.
$3MPart D
LOE ApproachingDeclining
small niche within ulcerative colitis treatment; approximately 2–3% estimated share
Declining commercial momentum and minimal claims indicate a shrinking team focus with limited growth opportunities.
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 offers limited career growth due to LOE approaching and minimal linked job openings. Work on this product is typically defensive and process-focused, suitable for professionals seeking a stable, lower-intensity role rather than a high-growth assignment.
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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.