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Profile for Tradename: OPANA ER

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Summary for Tradename: OPANA ER

Patents:12
Applicants:1
NDAs:2
Suppliers: see list8

Pharmacology for Tradename: OPANA ER

Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists

Clinical Trials for: OPANA ER

Effect of Extended-release Oxymorphone Taking With or Without Food on Cognitive Functioning
Status: Completed Condition: Chronic Pain

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

Bioavailability of Oxymorphone Hydrochloride 40 mg Extended Release Tablets Under Fasted Conditions
Status: Completed Condition: Pain

Bioavailability of Oxymorphone Hydrochloride 40 mg Extended Release Tablets Under Fed Conditions
Status: Completed Condition: Pain

A Pilot Study of Ultra Rapid Opioid Rotation and Titration of Oxymorphone
Status: Recruiting Condition: Chronic Nociceptive Pain; Neuropathic Pain; Non-cancer Pain

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

Open-Label Extension to Evaluate the Long-Term Safety, Tolerability and Analgesic Efficacy
Status: Completed Condition: Cancers, Pain; Lower Back Pain

Oxymorphone Extended Release (ER) in Opioid-Naive Patients With Chronic Pain
Status: Completed Condition: Pain; Chronic Disease

Open Label Assessment of Long-Term Safety and Utility
Status: Completed Condition: Pain

Oxymorphone Extended Release in Patients With Cancer or Neuropathic Pain
Status: Completed Condition: Chronic Pain; Neuropathic Pain; Cancer

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
Endo Pharms
OPANA ER
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL201655Dec 9, 2011RXYes8,808,737<disabled><disabled>
Endo Pharms
OPANA ER
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL021610Feb 29, 2008DISCNNo7,276,250<disabled>Y<disabled>
Endo Pharms
OPANA ER
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL201655Dec 9, 2011RXNo8,309,060<disabled>Y<disabled>
Endo Pharms
OPANA ER
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL021610Jun 22, 2006DISCNNo7,276,250<disabled>Y<disabled>
Endo Pharms
OPANA ER
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL201655Dec 9, 2011RXYes8,075,872<disabled>Y<disabled>
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Paragraph IV activity for: OPANA ER

Drugname Dosage Strength RLD Submissiondate
oxymorphone hydrochlorideExtended-release Tablets7.5 mg, 10 mg, and 15 mgOpana ER (NDA 201655)3/23/2012
oxymorphone hydrochlorideExtended-release Tablets5 mgOpana ER (NDA 201655)3/26/2012
oxymorphone hydrochlorideExtended-release Tablets20 mg, 30 mg, 40 mgOpana ER (NDA 201655)4/3/2012
oxymorphone hydrochlorideExtended-release Tablets30 mgOpana ER6/12/2008
oxymorphone hydrochlorideExtended-release Tablets7.5 mg and 15 mgOpana ER5/29/2008
oxymorphone hydrochlorideExtended-release Tablets5 mg, 10 mg, 20 mg and 40 mgOpana ER11/23/2007
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