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Details for Generic Name: oxymorphone hydrochloride

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Oxymorphone hydrochloride is the generic ingredient in four branded drugs marketed by Endo Pharms, Actavis Elizabeth, Impax Labs, Mallinckrodt Inc, Par Pharm, Roxane, Sun Pharm Inds Ltd, Avanthi Inc, Corepharma, and Teva, and is included in sixteen NDAs. There are ten patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has one hundred and ninety-four patent family members in thirty countries.

There are nine drug master file entries for oxymorphone hydrochloride. Nine suppliers are listed for this compound.

Summary for Generic Name: oxymorphone hydrochloride

Drug Master File Entries: see list9
Suppliers / Packaging: see list79
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details

Pharmacology for Ingredient: oxymorphone hydrochloride

Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists

Clinical Trials for: oxymorphone hydrochloride

Bioavailability of Oxymorphone Hydrochloride 40 mg Extended Release Tablets Under Fasted Conditions
Status: Completed Condition: 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
Endo Pharms
oxymorphone hydrochloride
SUPPOSITORY;RECTAL011738-004Approved Prior to Jan 1, 1982DISCNNo<disabled><disabled>
Endo Pharms
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL201655-005Dec 9, 2011RXNo8,808,737<disabled> <disabled>
Endo Pharms
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL201655-007Dec 9, 2011RXYes8,329,216<disabled>Y <disabled>
Endo Pharms
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL021610-002Jun 22, 2006DISCNNo7,276,250<disabled>Y <disabled>
Endo Pharms
oxymorphone hydrochloride
TABLET;ORAL021611-002Jun 22, 2006RXYes<disabled><disabled>
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International Patent Family for Ingredient: oxymorphone hydrochloride

Country Document Number Publication Date
Germany10361596Sep 29, 2005
European Patent Office1740156Jul 27, 2011
Russian Federation2009126774Jan 20, 2011
Denmark1658054Oct 01, 2007
Hong Kong1100639Nov 04, 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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