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Profile for Tradename: OPANA ER

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Opana Er is a drug marketed by Endo Pharms and is included in two NDAs. It is available from seven suppliers. There are ten patents protecting this drug and six Paragraph IV challenges.

This drug has one hundred and ninety-three patent family members in thirty countries.

The generic ingredient in OPANA ER is oxymorphone hydrochloride. There are nine drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the oxymorphone hydrochloride profile page.

Summary for Tradename: OPANA ER

Patents:10
Applicants:1
NDAs:2
Suppliers: see list7

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

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

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

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

Open Label Assessment of Long-Term Safety and Utility
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;ORAL021610-003Jun 22, 2006DISCNNo7,276,250<disabled>Y<disabled>
Endo Pharms
OPANA ER
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL201655-004Dec 9, 2011RXNo8,808,737<disabled><disabled>
Endo Pharms
OPANA ER
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL201655-005Dec 9, 2011RXNo8,192,722<disabled>Y<disabled>
Endo Pharms
OPANA ER
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL201655-006Dec 9, 2011RXNo8,192,722<disabled>Y<disabled>
Endo Pharms
OPANA ER
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL201655-005Dec 9, 2011RXNo8,075,872<disabled>Y<disabled>
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Paragraph IV activity for: OPANA ER

Drugname Dosage Strength RLD Submissiondate
oxymorphone hydrochlorideExtended-release Tablets20 mg, 30 mg, 40 mgOpana ER (NDA 201655)4/3/2012
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 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

Non-Orange Book Patents for Tradename: OPANA ER

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,420,056Abuse-proofed dosage form<disabled in preview>
8,114,384Process for the production of an abuse-proofed solid dosage form<disabled in preview>
8,748,611Processes for preparing morphinan-6-one products with low levels of alpha beta-unsaturated compounds<disabled in preview>
8,323,889Process for the production of an abuse-proofed solid dosage form<disabled in preview>
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International Patent Family for Tradename: OPANA ER

Country Document Number Publication Date
China101010071Aug 01, 2007
Peru01952006May 10, 2006
Canada2595954Aug 10, 2006
Denmark1658055Jul 02, 2007
Spain2336571Apr 14, 2010
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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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