OXYCONTIN (oxycodone hydrochloride)
OxyContin is indicated for the management of severe and persistent pain requiring long-term, daily opioid treatment when alternative options—such as non-opioid analgesics or immediate-release opioids—are inadequate or not tolerated. It is used in adults and in opioid-tolerant pediatric patients (11 years and older) who are already maintained on a minimum daily dose of at least 20 mg oxycodone or its equivalent. Due to the risks of addiction, abuse, and misuse, even at recommended doses, it is reserved for cases where other treatments are insufficient. It is not intended for use as an as-needed (prn) analgesic.
How OXYCONTIN Works
Oxycodone is a full opioid agonist that is relatively selective for mu receptors in the central nervous system (CNS), though it can bind to other receptors at higher doses. While the precise mechanism of its analgesic action is unknown, it is thought to work by binding to specific CNS receptors for endogenous compounds with opioid-like activity. As a full agonist, there is no ceiling effect to its analgesic efficacy; however, clinical dosage is limited by adverse reactions, most notably respiratory and CNS depression.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2010-04-05
- Patent Cliff
- 2030
- Routes
- ORAL
- Dosage Forms
- TABLET, EXTENDED RELEASE
OXYCONTIN Approval History
What OXYCONTIN Treats
1 indicationsOXYCONTIN is approved for 1 conditions since its original approval in 2010. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Pain
OXYCONTIN Boxed Warning
SERIOUS AND LIFE-THREATENING RISKS FROM USE OF OXYCONTIN Addiction, Abuse, and Misuse Because the use of OXYCONTIN exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, assess each patient's risk prior to prescribing and reassess all patients regularly for the development of these behaviors and conditions [see Warnings and Precautions (5.1) ]. Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respirat...
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF OXYCONTIN Addiction, Abuse, and Misuse Because the use of OXYCONTIN exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, assess each patient's risk prior to prescribing and reassess all patients regularly for the development of these behaviors and conditions [see Warnings and Precautions (5.1) ]. Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of OXYCONTIN, especially during initiation or following a dosage increase . To reduce the risk of respiratory depression, proper dosing and titration of OXYCONTIN are essential. Instruct patients to swallow OXYCONTIN tablets whole; crushing, chewing, or dissolving OXYCONTIN tablets can cause rapid release and absorption of a potentially fatal dose of oxycodone [see Warnings and Precautions (5.2) ] . Accidental Ingestion Accidental ingestion of even one dose of OXYCONTIN, especially by children, can result in a fatal overdose of oxycodone [see Warnings and Precautions (5.2) ]. Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of OXYCONTIN and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate [see Warnings and Precautions (5.3) , Drug Interactions (7) ] . Neonatal Opioid Withdrawal Syndrome (NOWS) Advise pregnant women using opioids for an extended period of time of the risk of Neonatal Opioid Withdrawal Syndrome, which may be life-threatening if not recognized and treated. Ensure that management by neonatology experts will be available at delivery [see Warnings and Precautions (5.4) ] . Opioid Analgesic Risk Evaluation and Mitig
OXYCONTIN Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to OXYCONTIN
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
15 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02536209 | MT-8554-E03 | Ph 1 | completed | A Study to Investigate the Pharmacodynamic Effect of Single Doses of MT-8554 in Healthy Subjects |
| NCT04240626 | 1452523 | Ph 4 | active not recruiting | Multimodal Analgesia Effect on Post Surgical Patient |
| NCT03685188 | WCH2018086 | Ph 4 | enrolling by invitation | Oxycodone and Sufentanil for Analgesia in Hip Surgery |
| NCT05043766 | PF614-102 | Ph 1 | completed | Evaluation of Oral PF614 Relative to OxyContin (PF614-102) |
| NCT06444997 | B2024-161R | Ph 4 | not yet recruiting | Efficacy and Safety of Oxycodone Hydrochloride for Long-term Analgesia in ICU Patients |
| NCT02531906 | I 262314 NCI-2015-01338, I 262314 | Ph 1 | completed | Gabapentin, Methadone Hydrochloride, and Oxycodone Hydrochloride in Improving Quality of Life in Patients With Stage II-IV Head and Neck Cancer During Chemoradiation |
| NCT03586934 | ORA 17071004 | Ph 3 | withdrawn | Multimodal Analgesia in Shoulder Arthroplasty |
| NCT01643772 results posted | OXYC09-CN-102 | Ph 1 | completed | OxyNorm® Capsules (Immediate-Release) Pharmacokinetic (PK) Study |
| NCT02660229 SWITCH results posted | OXI15-KR-401 | Ph 4 | completed | An Interventional Study for Patient With Cancer Pain to Evaluate the Efficacy and Safety of OxyNorm® Compared to Morphine Sulfate Through the IV Continuous Infusion. |
| NCT03254459 results posted | INS005-17-111 | Ph 2 | completed | Study of Buprenorphine Sublingual Spray Versus Standard of Care Narcotic Therapy for the Treatment of Post-Operative Pain |
| NCT00626600 | OXI3001 2007-005101-21 | Ph 3 | terminated | A Study to Assess the Safety and Tolerability of Oxycodone Hydrochloride 50mg/mL Administered as an Infusion |
| NCT03475862 | PTI-821-C08 | Ph 1 | completed | Nasal Human Abuse Potential of PTI-821 |
| NCT00801788 | OC-EG-001 | Ph 1 | completed | Single Dose Pharmacokinetics of Egalet® Oxycodone |
| NCT01557257 | B4531006 | Ph 1 | completed | Pharmacokinetics Study of ALO-02 and OxyContin |
| NCT01530542 | K234-10-1001 B4501006 | Ph 1 | completed | A Clinical Study To Characterize The Pharmacokinetics And The Effects Of Food On Oxycodone In Healthy Volunteers |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
OXYCONTIN FDA Label Details
Indications & Usage
FDA Label (PDF)OXYCONTIN is indicated for the treatment of Pain.
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF OXYCONTIN Addiction, Abuse, and Misuse Because the use of OXYCONTIN exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, assess each patient's risk prior to prescribing and ...
OXYCONTIN Patents & Exclusivity
Patents (15 active)
Pro Intelligence Preview
Deep insights for OXYCONTIN
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2030
- • 714 active patents
Trial Analysis
- • 22 total trials
- • Stage: Declining
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment