OxyContin

Small molecule

MMundipharma (China) Pharmaceutical Co. Ltd

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Clinical

Trials by Indication[1]

TED2 trials

OTR Tablet 10 mg Fasted-state Bioequivalence Study

Completed·MMundipharma (China) Pharmaceutical Co. Ltd·Phase 1·NCT03403504·24 enrolled

OTR Tablet 40 mg Fasted-state Bioequivalence Study

Completed·MMundipharma (China) Pharmaceutical Co. Ltd·Phase 1·NCT03398278·38 enrolled

Oxycodone2 trials

Fasting Study of Controlled-Release Oxycodone Hydrochloride 40 mg Tablets and OxyContin® 40 mg Tablets

Completed·MMallinckrodt·Phase 1·NCT00853892·34 enrolled

Fed Study of Controlled-Release Oxycodone Hydrochloride 40 mg Tablets and OxyContin® 40 mg Tablets

Completed·MMallinckrodt·Phase 1·NCT00853268·34 enrolled

Tics1 trial

Pharmacokinetics Study of ALO-02 and OxyContin

Completed· Pfizer logo

Pfizer·Phase 1·NCT01557257·13 enrolled

Fed1 trial

OTR Tablet 40 mg Fed-state Bioequivalence Study

Completed·MMundipharma (China) Pharmaceutical Co. Ltd·Phase 1·NCT03398330·42 enrolled

Abuse Potential1 trial

Nasal Human Abuse Potential of PTI-821

Completed·PPain Therapeutics·Phase 1·NCT03475862·38 enrolled

1 more indication

Oral1 trial

Evaluation of Oral PF614 Relative to OxyContin (PF614-102)

Completed·EEnsysce Biosciences·Phase 1·NCT05043766·84 enrolled

Regulatory

FDA Approval Timeline[3]

Apr 5, 2010

OXYCONTIN

NDA NDA022272

Jun 29, 2010

OXYCONTIN

NDA NDA022272

Nov 15, 2010

OXYCONTIN

NDA NDA022272

Oct 5, 2011

OXYCONTIN

NDA NDA022272

Jul 9, 2012

OXYCONTIN

NDA NDA022272

Jul 9, 2012

OXYCONTIN

NDA NDA022272

Jan 11, 2013

OXYCONTIN

NDA NDA022272

Apr 15, 2013

OXYCONTIN

NDA NDA022272

Apr 16, 2013

OXYCONTIN

NDA NDA022272

Jan 31, 2014

OXYCONTIN

NDA NDA022272

Feb 4, 2014

OXYCONTIN

NDA NDA022272

Apr 16, 2014

OXYCONTIN

NDA NDA022272

Aug 19, 2014

OXYCONTIN

NDA NDA022272

Oct 13, 2014

OXYCONTIN

NDA NDA022272

Oct 22, 2014

OXYCONTIN

NDA NDA022272

Jun 26, 2015

OXYCONTIN

NDA NDA022272

Aug 13, 2015

OXYCONTIN

NDA NDA022272

Sep 10, 2015

OXYCONTIN

NDA NDA022272

Nov 12, 2015

OXYCONTIN

NDA NDA022272

Mar 25, 2016

OXYCONTIN

NDA NDA022272

Mar 28, 2016

OXYCONTIN

NDA NDA022272

Apr 20, 2016

OXYCONTIN

NDA NDA022272

Sep 30, 2016

OXYCONTIN

NDA NDA022272

Dec 16, 2016

OXYCONTIN

NDA NDA022272

May 26, 2017

OXYCONTIN

NDA NDA022272

Sep 18, 2018

OXYCONTIN

NDA NDA022272

Sep 18, 2018

OXYCONTIN

NDA NDA022272

Sep 26, 2018

OXYCONTIN

NDA NDA022272

Oct 7, 2019

OXYCONTIN

NDA NDA022272

Nov 14, 2019

OXYCONTIN

NDA NDA022272

Mar 4, 2021

OXYCONTIN

NDA NDA022272

Oct 28, 2021

OXYCONTIN

NDA NDA022272

Dec 15, 2023

OXYCONTIN

NDA NDA022272

Oct 31, 2024

OXYCONTIN

NDA NDA022272

Dec 22, 2025

OXYCONTIN

NDA NDA022272

Jun 18, 2026

OXYCONTIN

NDA NDA022272

Sources

References

[1]
ClinicalTrials.gov — 8 trial records for OxyContin. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — OxyContin compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
OpenFDA — FDA approval records (NDA NDA022272). U.S. Food & Drug Administration.
[4]
SEC EDGAR — Mundipharma (China) Pharmaceutical Co. Ltd company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Company: MMundipharma (China) Pharmaceutical Co. Ltd

OxyContin

Trials by Indication[1]

TED2 trials

Oxycodone2 trials

Tics1 trial

Fed1 trial

Abuse Potential1 trial

Oral1 trial

FDA Approval Timeline[3]

References

Drug Info

Quick Facts

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