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 2d ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
IMURAN (azathioprine sodium) is a small-molecule purine analog immunosuppressant used to reduce signs and symptoms of active rheumatoid arthritis. It works by being metabolized to 6-mercaptopurine, which is further converted to 6-thioguanine nucleotides that incorporate into DNA and suppress T-cell activation. The drug's efficacy depends on thiopurine S-methyltransferase (TPMT) and NUDT15 enzyme activity, making pharmacogenetic testing critical for safe dosing.
$0.434MPart D
LOE ApproachingDeclining
As a product approaching loss of exclusivity with minimal Part D spending ($434K in 2023), the brand team is likely small and focused on managing declining market share against modern JAK inhibitors and TNF-blockers.
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.