NDAORALTABLET, EXTENDED RELEASEPriority Review
Approved
Apr 2010
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
12
Data completeness
5/8 — Partial
Priority Review
OXYCONTIN (oxycodone hydrochloride) by Purdue Pharma is receptor, although it can bind to other opioid receptors at higher doses. First approved in 2010.
Drug data last refreshed 3h ago · AI intelligence enriched 6h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
OxyContin is an extended-release oral tablet formulation of oxycodone hydrochloride, a full opioid agonist indicated for moderate-to-severe chronic pain management. The drug works by binding to mu-opioid receptors in the brain and spinal cord to produce analgesia with no ceiling effect on pain relief. Dosing is titrated based on patient tolerance and efficacy, with clinical outcomes limited by adverse effects including respiratory and CNS depression.
$0.391BPart D
Peak3.5 years to LOEPeak-stage product with substantial Part D utilization ($391M, 535k+ claims in 2023) indicates mature commercial infrastructure and stable team footprint, but approaching patent cliff creates urgency around lifecycle extension initiatives.
Mechanism of Action
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 to analgesia for oxycodone. Clinically, dosage is titrated to provide adequate analgesia and may be limited…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (12)
Abuse Potential of Gabapentin Taken Orally Concomitantly With Oxycodone Hydrochloride in Healthy, Non-Drug-Dependent, Recreational Opioid Users
Started Aug 2026
60 enrolled
Healthy, Non-Drug- Dependent, Recreational Opioid Users
A Research Study of an Investigational Drug ALO-02 (Oxycodone Hydrochloride and Naltrexone Hydrochloride) in Patients With Moderate to Severe Chronic Low Back Pain
Started Jun 2012
410 enrolled
Chronic PainLow Back PainAnalgesia
Pharmacokinetics Study of ALO-02 and OxyContin
Started Mar 2012
13 enrolled
Management of Moderate to Severe Pain
Long-Term Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Children Who Completed OTR3001
Started Oct 2011
23 enrolled
Pain
Safety Study of Oxycodone Hydrochloride and Naltrexone Hydrochloride Extended-Release Capsules in Subjects With Moderate to Severe Chronic Noncancer Pain
Started Dec 2010
395 enrolled
Chronic Noncancer Pain
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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.