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 4h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Fioricet w/ Codeine is an oral fixed-dose combination analgesic containing butalbital (barbiturate), acetaminophen, caffeine, and codeine phosphate (weak opioid). It treats tension headaches and muscle contraction headaches when alternative treatments are inadequate. The combination works through multiple mechanisms: barbiturate CNS depression, acetaminophen analgesia, caffeine as a CNS stimulant, and codeine as a mu-opioid agonist.
LOE Approaching
Mature product approaching loss of exclusivity with moderate competitive pressure (30%); team size likely stable but declining as generic entry accelerates.
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.