NDAORALCAPSULE
Approved
Jul 1992
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
4/8 — Partial
FIORICET W/ CODEINE (butalbital, acetaminophen, caffeine, and codeine phosphate) by Teva is butalbital, a barbiturate, is a gaba a receptor agonist and may inhibit excitatory ampa receptors. Approved for the symptom complex of tension (or muscle contraction) headache, alternative treatments are inadequate, other non-opioid analgesic. First approved in 1992.
Drug data last refreshed 13h ago · AI intelligence enriched 2d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Fioricet w/ Codeine is an oral fixed-dose combination of butalbital (barbiturate), acetaminophen, caffeine, and codeine phosphate (opioid) indicated for tension headaches when alternative treatments are inadequate. The product works through multiple mechanisms: butalbital acts as a GABA-A receptor agonist for CNS depression, acetaminophen provides central analgesic effects, caffeine antagonizes adenosine receptors as a CNS stimulant, and codeine acts as a mu-opioid receptor agonist.
LOE Approaching
Product faces approaching loss of exclusivity with moderate competitive pressure (30); brand teams should expect declining revenue and a right-sizing of commercial infrastructure.
Mechanism of Action
Butalbital, a barbiturate, is a GABA A receptor agonist and may inhibit excitatory AMPA receptors. The precise mechanism of the analgesic properties of acetaminophen is not established but is thought to involve central actions. Caffeine is a methylxanthine and CNS stimulant. The exact mechanism…
Pharmacologic Class:
Barbiturate
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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.