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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 Avanthi Inc, Coastal Pharms, Lannett Holdings Inc, Lehigh Valley, Novel Labs Inc, Ani Pharms Inc, Roxane, Vistapharm, Wockhardt Bio Ag, Purdue Pharma Lp, Egalet Us Inc, Actavis Elizabeth, Alvogen Inc, Amneal Pharms, Aurolife Pharma Llc, Corepharma, Epic Pharma Llc, Mallinckrodt Inc, Nesher Pharms, Rhodes Pharms, Sun Pharm Inds Inc, and Vintage Pharms, 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 three hundred and ninety-eight patent family members in forty-two 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

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
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
Sun Pharm Inds Inc
oxycodone hydrochloride
TABLET;ORAL090659-001Apr 10, 2009RXNo<disabled><disabled>
Purdue Pharma Lp
oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022272-004Apr 5, 2010RXNo8,337,888<disabled>Y <disabled>
Actavis Elizabeth
oxycodone hydrochloride
TABLET;ORAL076636-001Feb 6, 2004RXNo<disabled><disabled>
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International Patent Family for Ingredient: oxycodone hydrochloride

Country Document Number Publication Date
Hong Kong1155728Jul 31, 2015
New Zealand602862Jan 31, 2014
European Patent Office2384754Mar 20, 2013
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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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