NDAORALTABLET, DELAYED RELEASEPriority Review
Approved
Jul 2004
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
2/8 — Basic
Priority Review
CAMPRAL (acamprosate calcium) by Forest Devices is understood. First approved in 2004.
Drug data last refreshed 18h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CAMPRAL (acamprosate calcium) is an oral delayed-release tablet approved in 2004 for maintaining abstinence in alcohol-dependent patients. It is hypothesized to restore the balance between glutamate and GABA neurotransmitter systems disrupted by chronic alcohol exposure. The exact mechanism remains incompletely understood, though preclinical evidence suggests central nervous system modulation.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30%), signaling a transitioning commercial organization focused on legacy management and potential generic transition planning.
Mechanism of Action
understood. Chronic alcohol exposure is hypothesized to alter the normal balance between neuronal excitation and inhibition. and studies in animals have provided evidence to suggest acamprosate may interact with glutamate and GABA neurotransmitter systems centrally, and has led to the hypothesis…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Career Relevance
Working on CAMPRAL represents a career opportunity in managing a mature, specialty-focused product navigating transition from branded to generic era. Professionals should expect roles centered on defending market share, managing payer relationships, and executing operational efficiency rather than growth-stage innovation.
Brand Manager
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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.