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 11h ago · AI intelligence enriched 14h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
APADAZ is an oral fixed-dose combination tablet containing benzhydrocodone (a hydrocodone prodrug) and acetaminophen, approved in 2018 for moderate to moderately severe pain. Hydrocodone is a full mu-opioid receptor agonist providing analgesia with no ceiling effect, while acetaminophen provides complementary non-opioid analgesic action through central mechanisms. The combination leverages the synergistic pain relief of opioid and non-opioid mechanisms.
Peak4.4 years to LOE
Product is at peak commercial stage with established market presence; Medical Affairs and cross-functional teams are maintaining market position amid high competitive pressure.
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.