NDAORALTABLETPriority Review
Approved
Feb 2018
Lifecycle
Peak
Competitive Pressure
8/100
Data completeness
4/8 — Partial
Priority Review
APADAZ (benzhydrocodone and acetaminophen) by Zevra Therapeutics is hydrocodone. First approved in 2018.
Drug data last refreshed 20h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
APADAZ is an oral tablet combining benzhydrocodone (a full mu-opioid agonist) and acetaminophen for pain management. Hydrocodone provides analgesia through opioid receptor agonism with no ceiling effect, while acetaminophen contributes non-opioid analgesic effects. The combination addresses moderate to moderately severe pain requiring both opioid and non-opioid mechanisms.
Peak4.8 years to LOE
Product is in peak lifecycle stage with 11 linked job openings, indicating active commercial infrastructure supporting market maintenance and optimization.
Mechanism of Action
hydrocodone. Hydrocodone Hydrocodone is a full opioid agonist with relative selectivity for the mu-opioid receptor, although it can interact with other opioid receptors at higher doses. The principal therapeutic action of hydrocodone is analgesia. Like all full opioid agonists, there is no ceiling…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Why This Matters for Your Career
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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.