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Details for Generic Name: oxycodone hydrochloride

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Oxycodone hydrochloride is the generic ingredient in four branded drugs marketed by Novel Labs Inc, Coastal Pharms, Roxane, Mallinckrodt Inc, Vintage Pharms, Alvogen Malta, Lannett Holdings Inc, Lehigh Valley, Actavis Elizabeth, Vistapharm, Amneal Pharms, Wockhardt Bio Ag, Sun Pharm Inds Inc, Aurolife Pharma Llc, Epic Pharma Llc, Purdue Pharma Lp, Avanthi Inc, Ani Pharms Inc, Egalet Us Inc, Nesher Pharms, Rhodes Pharms, and Corepharma, and is included in thirty-two NDAs. There are eighteen patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has four hundred and ten patent family members in forty-four countries.

There are seventeen drug master file entries for oxycodone hydrochloride. Eighteen suppliers are listed for this compound. There are six tentative approvals for this compound.

Summary for Generic Name: oxycodone hydrochloride

Tradenames:4
Patents:18
Applicants:22
NDAs:32
Drug Master File Entries: see list17
Suppliers / Packaging: see list107
Therapeutic Class:Analgesics

Pharmacology for Ingredient: oxycodone hydrochloride

Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists

Tentative approvals for OXYCODONE HYDROCHLORIDE

Applicant Application No. Form Dosage
<disabled><disabled>TABLET, EXTENDED RELEASE; ORAL10MG
<disabled><disabled>TABLET, EXTENDED RELEASE; ORAL20MG
<disabled><disabled>TABLET, EXTENDED RELEASE; ORAL40MG

Clinical Trials for: oxycodone hydrochloride

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

Early Postoperative Administration of Oxycodone +/- Naloxone and Duration of Epidural Analgesia
Status: Recruiting Condition: Postoperative Pain Management; Radical Cystectomy; Epidural Analgesia; Oral Oxycodone With/Without Naloxone; Return of the Bowel Function

Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Children With Moderate to Severe Malignant and/ or Nonmalignant Pain Requiring Opioids
Status: Completed Condition: Pain

Pharmacokinetics And Relative Bioavailability Study Of Oxycodone
Status: Completed Condition: Pain

Long-Term Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Children Who Completed OTR3001
Status: Completed Condition: Pain

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

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
Novel Labs Inc
OXYCODONE HYDROCHLORIDE
oxycodone hydrochloride
CAPSULE;ORAL204752-001Aug 24, 2015RXNo<disabled><disabled>
Purdue Pharma Lp
OXYCONTIN
oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022272-003Apr 5, 2010RXNo8,337,888<disabled>Y <disabled>
Egalet Us Inc
OXAYDO
oxycodone hydrochloride
TABLET;ORAL202080-001Jun 17, 2011RXNo7,201,920<disabled>Y <disabled>
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Expired Orange Book Patents for Generic Ingredient: oxycodone hydrochloride

These historical archives are available as an add-on to one-year subscriptions

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Purdue Pharma Lp
OXYCONTIN
oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022272-004Apr 5, 20105,508,042<disabled>
Purdue Pharma Lp
OXYCONTIN
oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022272-007Apr 5, 20105,508,042<disabled>
Purdue Pharma Lp
OXYCONTIN
oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022272-001Apr 5, 20105,508,042<disabled>
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International Patent Family for Ingredient: oxycodone hydrochloride

Country Document Number Publication Date
Slovenia1699440Mar 31, 2010
European Patent Office1859789Nov 28, 2007
Peru11842009Aug 03, 2009
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided information. There is no warranty that the information contained herein is error free. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

Copyright 2002-2016 thinkBiotech LLC
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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