NDAORALCAPSULEPriority Review
Approved
Jul 1990
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
5/8 — Partial
Priority Review
DIPENTUM (olsalazine sodium) by Viatris 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 13h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DIPENTUM (olsalazine sodium) is an oral small-molecule prodrug approved in 1990 for ulcerative colitis. Colonic bacteria convert olsalazine into 5-aminosalicylic acid (5-ASA), which exerts topical anti-inflammatory effects by inhibiting prostaglandin production and blocking cyclooxygenase pathways in colonic epithelial cells.
$0.003BPart D
LOE ApproachingDeclining
LOE approaching with modest Part D spending ($3M, 1,408 claims in 2023) signals a mature, contracted franchise with reduced headcount requirements.
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 expansion opportunity; with zero linked job openings and LOE approaching, roles are primarily defensive—maintaining existing market share, supporting prescribers, and managing the transition to generic competition. Positions on this team focus on operational efficiency and compliance rather than growth.
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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.