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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-five 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

Tradenames:4
Patents:10
Applicants:10
NDAs:16
Drug Master File Entries: see list9
Suppliers / Packaging: see list79
Therapeutic Class:Analgesics

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 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
Endo Pharms
OPANA ER
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL201655-002Dec 9, 2011RXNo8,075,872<disabled>Y <disabled>
Endo Pharms
OPANA ER
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL201655-007Dec 9, 2011RXYes8,114,383<disabled>Y <disabled>
Endo Pharms
OPANA ER
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL021610-005Feb 29, 2008DISCNNo7,276,250<disabled>Y <disabled>
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Expired Orange Book Patents for Generic Ingredient: oxymorphone hydrochloride

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Endo Pharms
OPANA ER
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL021610-007Feb 29, 20085,662,933<disabled>
Endo Pharms
OPANA ER
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL021610-001Jun 22, 20065,128,143<disabled>
Endo Pharms
OPANA ER
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL021610-002Jun 22, 20065,662,933<disabled>
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International Patent Family for Ingredient: oxymorphone hydrochloride

Country Document Number Publication Date
BrazilPI0606145Jun 02, 2009
China1980643May 30, 2012
Portugal1658055Jul 24, 2007
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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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