NDAORALSUSPENSION
Approved
Dec 1980
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
8
Data completeness
5/8 — Partial
AZULFIDINE (sulfasalazine) by Pfizer is clinical pharmacology pharmacodynamics the mode of action of sulfasalazine (ssz) or its metabolites, 5-aminosalicylic acid (5-asa) and sulfapyridine (sp), may be related to the anti-inflammatory and/or immunomodulatory properties that have been observed in animal and in vitro models, to its affinity for connective tissue, and/or to the relatively high concentration it reaches in serous fluids, the liver and intestinal walls, as demonstrated in autoradiographic studies in animals. Approved for ulcerative colitis, whom there is evidence, its metabolites. First approved in 1980.
Drug data last refreshed 4h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AZULFIDINE (sulfasalazine) is an oral anti-inflammatory immunomodulatory agent used primarily to treat ulcerative colitis. The drug is metabolized by intestinal bacteria into its active metabolites 5-aminosalicylic acid (5-ASA) and sulfapyridine (SP), which exert anti-inflammatory effects on colonic epithelial tissue. In ulcerative colitis, the 5-ASA moiety is believed to be the primary therapeutic component.
$0.272MPart D
LOE ApproachingStable
As a legacy product approaching loss of exclusivity, the brand team is likely operating in maintenance/harvest mode with reduced headcount and a focus on cost containment rather than expansion.
Mechanism of Action
CLINICAL PHARMACOLOGY Pharmacodynamics The mode of action of sulfasalazine (SSZ) or its metabolites, 5-aminosalicylic acid (5-ASA) and sulfapyridine (SP), may be related to the anti-inflammatory and/or immunomodulatory properties that have been observed in animal and in vitro models, to its…
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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.