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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

Tradenames:4
Patents:10
Applicants:10
NDAs:16
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 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;ORAL201655-003Dec 9, 2011RXNo8,309,060<disabled>Y<disabled>
Endo Pharms
OPANA ER
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL201655-003Dec 9, 2011RXNo8,329,216<disabled>Y<disabled>
Impax Labs
OXYMORPHONE HYDROCHLORIDE
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL079087-002Dec 21, 2010RXNo<disabled><disabled>
Endo Pharms
OPANA ER
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL201655-006Dec 9, 2011RXNo8,808,737<disabled><disabled>
Par Pharm
OXYMORPHONE HYDROCHLORIDE
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL200792-006Oct 24, 2014RXNo<disabled><disabled>
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International Patent Family for Ingredient: oxymorphone hydrochloride

Country Document Number Publication Date
Japan4786748Oct 05, 2011
Denmark1699440Mar 29, 2010
World Intellectual Property Organization (WIPO)03004033Jan 16, 2003
China101652371Feb 17, 2010
China1538846Oct 20, 2004
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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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