NDAORALSUSPENSION
Approved
Dec 1980
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
7
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 rheumatoid arthritis, psoriatic arthritis. First approved in 1980.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AZULFIDINE (sulfasalazine) is an oral small-molecule DMARD approved in 1980 for rheumatoid arthritis, psoriatic arthritis, and related inflammatory conditions. It works through anti-inflammatory and immunomodulatory mechanisms, with its active 5-ASA metabolite being the primary therapeutic agent in ulcerative colitis and its contribution in RA remaining partially unclear. The drug is metabolized by intestinal bacteria with <15% bioavailability of parent compound.
$0.272MPart D
LOE ApproachingDeclining
Product is in late-life-cycle with minimal Part D utilization (601 claims, 2023), indicating shrinking brand team and support requirements.
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…
Worked on AZULFIDINE at Pfizer? Share your interview experience or compensation data (+7 days Pro)
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.