NDAORALTABLETPriority Review
Approved
Apr 2017
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
4
Data completeness
6/8 — Strong
Priority Review
ROXYBOND (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 and 1 more indications. First approved in 2017.
Drug data last refreshed 18h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ROXYBOND is an oral immediate-release oxycodone hydrochloride tablet approved in 2017 for acute and chronic pain management, including osteoarthritis and opioid use disorder. It works as a mu-opioid receptor full agonist with no ceiling effect for analgesia, though clinically limited by adverse effects including respiratory and CNS depression. The precise mechanism remains incompletely understood but involves endogenous opioid receptors throughout the brain and spinal cord.
$0.771MPart D
LOE Approaching2.3 years to LOEProduct is approaching loss of exclusivity in 2.3 years with minimal current Part D penetration, suggesting a mature niche product with limited team expansion opportunities.
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 (4)
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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.