NDAORALTABLETPriority Review
Approved
Jun 2011
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
4
Data completeness
5/8 — Partial
Priority Review
OXAYDO (oxycodone hydrochloride) by Bayer is mu-opioid receptor, although it can bind to other opioid receptors at higher doses. Approved for pain, acute pain, chronic pain. First approved in 2011.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
OXAYDO is an oral tablet formulation of oxycodone hydrochloride, a mu-opioid receptor agonist approved in 2011 for management of acute and chronic pain, including osteoarthritis and opioid use disorder. The drug works by binding to opioid receptors in the brain and spinal cord to produce analgesia with no ceiling effect on pain relief. Dosing is titrated based on patient response and tolerability, with limiting adverse effects including respiratory and CNS depression.
$0.695MPart D
PeakOXAYDO remains in peak revenue stage with modest Medicare Part D penetration ($695K), indicating a mature, niche product with limited commercial growth trajectory and likely smaller team footprint.
Mechanism of Action
mu-opioid receptor, although it can bind to other opioid receptors at higher doses. The principal therapeutic action of oxycodone is analgesia. Like all full opioid agonists, there is no ceiling effect for analgesia with oxycodone. Clinically, dosage is titrated to provide adequate analgesia and…
Indications (3)
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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.