NDAINJECTIONINJECTABLEPriority Review
Approved
Jul 1974
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
2
Data completeness
5/8 — Partial
Priority Review
IMURAN (azathioprine sodium) by R-Pharm US is clinical pharmacology azathioprine is well absorbed following oral administration. Approved for active rheumatoid arthritis to reduce signs, symptoms, active rheumatoid arthritis (ra) to reduce signs and 2 more indications. First approved in 1974.
Drug data last refreshed 18h ago · AI intelligence enriched 3d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
IMURAN (azathioprine sodium) is an immunosuppressive agent indicated for reducing signs and symptoms of active rheumatoid arthritis. The drug works by metabolizing to 6-mercaptopurine, which is converted to 6-thioguanine nucleotides that incorporate into DNA to exert cytotoxic effects on immune cells. It is administered via injection and has been in use since 1974.
$434KPart D
LOE ApproachingWith LOE approaching and declining market share pressured by competitive corticosteroid alternatives, brand team size and support are likely contracting.
Mechanism of Action
CLINICAL PHARMACOLOGY Azathioprine is well absorbed following oral administration. Maximum serum radioactivity occurs at 1 to 2 hours after oral S-azathioprine and decays with a half-life of 5 hours. This is not an estimate of the half-life of azathioprine itself, but is the decay rate for all…
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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.