NDARECTALENEMAPriority Review
Approved
Dec 1987
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
20
Data completeness
6/8 — Strong
Priority Review
ROWASA (mesalamine) by Viatris (2) is understood, but appears to be a topical anti-inflammatory effect on colonic epithelial cells. Approved for ulcerative colitis, crohn's disease, proctitis. First approved in 1987.
Drug data last refreshed 18h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ROWASA (mesalamine) is a topical aminosalicylate administered as a rectal enema for the treatment of ulcerative colitis, Crohn's disease, proctitis, and colitis. It works by reducing inflammation in the colon through local inhibition of prostaglandin production and arachidonic acid metabolites. The drug delivers anti-inflammatory effects directly to colonic epithelial cells.
$0.069BPart D
LOE ApproachingDeclining
1.2 years to LOEWith LOE approaching in 1.3 years and minimal Part D spending ($69K in 2023), ROWASA presents a shrinking commercial footprint requiring focused retention and generic transition strategies.
Mechanism of Action
understood, but appears to be a topical anti-inflammatory effect on colonic epithelial cells. Mucosal production of arachidonic acid metabolites, both through the cyclooxygenase pathways, i.e., prostanoids, and through the lipoxygenase pathways, i.e., leukotrienes and hydroxyeicosatetraenoic acids,…
Pharmacologic Class:
Aminosalicylate
Indications (3)
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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.