NDAORALSOLUTIONPriority Review
Approved
Dec 1987
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
1/8 — Limited
Priority Review
Drug data last refreshed 18h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
UCEPHAN is an oral solution containing sodium benzoate and sodium phenylacetate, approved in 1987 for the treatment of urea cycle disorders and hyperammonemia. The combination works by providing alternative pathways for nitrogen disposal, reducing ammonia levels in patients with genetic defects in the urea cycle. This is a foundational hyperammonemia therapy used primarily in pediatric and adult populations with severe metabolic disorders.
LOE Approaching
Product is in late maturity with competitive pressure at 30%, signaling a small, maintenance-focused team rather than a growth organization.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Career Relevance
Working on UCEPHAN offers stability in a specialized rare disease market, but limited career growth due to its mature lifecycle and approaching LOE. Professionals on this team should expect focus on market maintenance, compliance, and transitional planning rather than expansion or innovation.
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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.