NDAORALTABLETPriority Review
Approved
Jun 1950
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
8
Data completeness
5/8 — Partial
Priority Review
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. First approved in 1950.
Drug data last refreshed 6h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Sulfasalazine (AZULFIDINE) is a small-molecule aminosalicylate approved in 1950 for ulcerative colitis and rheumatoid arthritis. It works through anti-inflammatory and immunomodulatory mechanisms, with the active 5-ASA moiety delivering therapeutic benefit primarily in the colon via bacterial metabolism. The drug is administered orally and has low systemic bioavailability (<15%), concentrating in intestinal walls and connective tissue.
$0.272MPart D
LOE ApproachingThis mature, off-patent product faces LOE with minimal market growth; commercial teams are typically small and focused on retention and cost management.
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.