NDAORALSOLUTIONPriority Review
Approved
Dec 1987
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
1/8 — Limited
Priority Review
Drug data last refreshed 17h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
UCEPHAN is an oral solution combining sodium benzoate and sodium phenylacetate, approved in 1987 for the management of hyperammonemia and urea cycle disorders. These agents work by providing alternative pathways for nitrogen excretion, reducing ammonia levels in patients who cannot process nitrogen through the normal urea cycle. The combination therapy addresses a critical metabolic need in a rare disease population.
LOE Approaching
As an aging rare disease therapy nearing loss of exclusivity with modest competitive pressure (30%), the brand team is likely focused on lifecycle management and patient retention rather than growth.
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 specialized experience in rare disease management, patient advocacy, and lifecycle sustainability rather than commercial growth. Career progression on this product is best suited for professionals interested in niche therapeutics, medical affairs depth, and outcomes research in metabolic disorders.
Medical Science Liaison (rare disease focus)Regulatory Affairs Specialist
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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.