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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, Avanthi Inc, and Teva, and is included in fourteen NDAs. There are twelve patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

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:12
Applicants:8
NDAs:14
Drug Master File Entries: see list9
Suppliers: see list9
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

Open-Label Safety and Tolerability of Oxymorphone IR and ER in Opioid Tolerant Pediatric Subjects
Status: Terminated Condition: Chronic Pain

Study to Compare Oxymorphone Extended-Release (Opana ER) Versus Oxycodone Controlled-Release (Oxycontin)
Status: Completed Condition: Healthy

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Roxane
OXYMORPHONE HYDROCHLORIDE
oxymorphone hydrochloride
TABLET;ORAL090964Sep 27, 2010RXNo<disabled><disabled>
Endo Pharms
OPANA ER
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL201655Dec 9, 2011RXYes8,075,872<disabled>Y<disabled>
Actavis Elizabeth
OXYMORPHONE HYDROCHLORIDE
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL079046Jul 11, 2013RXNo<disabled><disabled>
Endo Pharms
OPANA ER
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL201655Dec 9, 2011RXYes8,871,779<disabled>Y<disabled>
Endo Pharms
OPANA ER
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL021610Feb 29, 2008DISCNNo5,662,933<disabled>Y<disabled>
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