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 4h ago · AI intelligence enriched 1mo 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. It works by binding to opioid receptors in the central nervous system to produce analgesia, with no ceiling effect on analgesic efficacy. The precise mechanism involves modulation of endogenous opioid-like activity in the brain and spinal cord.
$0.391BPart D
Peak3.4 years to LOEProduct is at peak lifecycle with substantial Medicare utilization (535k+ claims), indicating an established market with stable team requirements and mature commercial infrastructure.
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
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.