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Profile for Tradename: OXYCONTIN

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Oxycontin is a drug marketed by Purdue Pharma Lp and is included in one NDA. It is available from ten suppliers. There are thirteen patents protecting this drug and seven Paragraph IV challenges.

This drug has three hundred and seventy-seven patent family members in forty-one countries.

The generic ingredient in OXYCONTIN is oxycodone hydrochloride. There are seventeen drug master file entries for this compound. Seventeen suppliers are listed for this compound. There are six tentative approvals for this compound. Additional details are available on the oxycodone hydrochloride profile page.

Summary for Tradename: OXYCONTIN

Patents:13
Applicants:1
NDAs:1
Suppliers / Packagers: see list78
2013 Sales:$2,534,909,000

Pharmacology for Tradename: OXYCONTIN

Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists

Clinical Trials for: OXYCONTIN

Pharmacokinetics Study of ALO-02 and OxyContin
Status: Completed Condition: Management of Moderate to Severe Pain

Early Postoperative Administration of Oxycodone +/- Naloxone and Duration of Epidural Analgesia
Status: Not yet recruiting Condition: Postoperative Pain Management; Radical Cystectomy; Epidural Analgesia; Oral Oxycodone With/Without Naloxone; Return of the Bowel Function

Study of PF614 Compared to OxyContin® in Healthy Volunteers
Status: Not yet recruiting Condition: Healthy

Pharmacokinetics And Relative Bioavailability Study Of Oxycodone
Status: Completed Condition: Management of Moderate to Severe Pain

A Study to Evaluate Efficacy and Safety of Oxycodone/Naloxone Compared to OxyContin in Korean Cancer Patients
Status: Completed Condition: Cancer

Comparison of the Effects of Tapentadol and Oxycodone on Gastrointestinal and Colonic Transit in Humans
Status: Completed Condition: Effects of 2 Mu-opiates on Gastrointestinal Transit

Oxycodone Versus Intravenous Morphine for Postoperative Analgesia After Hip Surgery
Status: Recruiting Condition: Arthroplasty, Replacement, Hip

A Open-label, Single-dose Study to Investigate The Pharmacokinetics Between a GL2907 XL and Oxycontin CR Tab. 10mg in Healthy Male Volunteers
Status: Completed Condition: Healthy

Abuse Liability of Controlled-Release Oxycodone Formulations
Status: Completed Condition: Substance-Related Disorders

A Study to Determine the Fed Bioequivalence of Reformulated OXY Tablets and Original OxyContin® (OXY) Tablets
Status: Completed Condition: Healthy Volunteers

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Purdue Pharma Lp
OXYCONTIN
oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022272-006Apr 5, 2010RXNo9,060,976<disabled>Y<disabled>
Purdue Pharma Lp
OXYCONTIN
oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022272-003Apr 5, 2010RXNo7,674,799<disabled>Y<disabled>
Purdue Pharma Lp
OXYCONTIN
oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022272-003Apr 5, 2010RXNo8,114,383<disabled>Y<disabled>
Purdue Pharma Lp
OXYCONTIN
oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022272-007Apr 5, 2010RXNo9,060,976<disabled>Y<disabled>
Purdue Pharma Lp
OXYCONTIN
oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022272-004Apr 5, 2010RXNo8,894,988<disabled>Y<disabled>
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Paragraph IV activity for: OXYCONTIN

Drugname Dosage Strength RLD Submissiondate
oxycodone hydrochlorideExtended-release Tablet15 mgOxyContin (NDA 022272)10/28/2010
oxycodone hydrochlorideExtended-release Tablet10 mgOxyContin (NDA 022272)10/25/2010
oxycodone hydrochlorideExtended-release Tablet40 mgOxyContin (NDA 022272)10/4/2010
oxycodone hydrochlorideExtended-release Tablet30 mg, 60 mg and 80 mgOxyContin (NDA 022272)10/18/2010
oxycodone hydrochlorideExtended-release Tablet20 mgOxyContin (NDA 022272)10/29/2010
oxycodone hydrochlorideExtended-release Tablets15 mgOxycontin2/15/2007
oxycodone hydrochlorideExtended-release Tablets30 mg and 60 mgOxycontin1/3/2007

International Patent Family for Tradename: OXYCONTIN

Country Document Number Publication Date
Japan2012072162Apr 12, 2012
European Patent Office1699440Nov 11, 2009
Taiwan200824722Jun 16, 2008
European Patent Office2343071Jul 13, 2011
Portugal2070538Mar 02, 2011
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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