NDARECTALENEMAPriority Review
Approved
Dec 1987
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
20
Data completeness
6/8 — Strong
Priority Review
SFROWASA (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. First approved in 1987.
Drug data last refreshed 18h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SFROWASA (mesalamine) is a rectal enema formulation of an aminosalicylate anti-inflammatory approved in 1987 for ulcerative colitis, Crohn's disease, proctitis, and IBS-D. It works by inhibiting cyclooxygenase and blocking prostaglandin production in the colon, reducing mucosal inflammation. The drug is administered topically to the colonic epithelium for localized anti-inflammatory effect.
$0.030BPart D
LOE Approaching1.2 years to LOEDeclining commercial opportunity as product approaches loss of exclusivity in mid-2027; brand team likely consolidating with minimal new investment.
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 (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.