Deep knowledge on 
 small-molecule drugs and 
 the 110,000 global patents 
 covering them 

Free Patent Expiration Alerts


Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

OPANA ER Drug Profile

« Back to Dashboard
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-six 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. Eighteen 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 / Packagers: see list7

Pharmacology for Tradename: OPANA ER

Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists

Clinical Trials for: OPANA ER

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;ORAL201655-004Dec 9, 2011RXNo8,075,872<disabled>Y <disabled>
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;ORAL201655-005Dec 9, 2011RXNo8,309,122<disabled>Y <disabled>
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Expired Patents for Tradename: OPANA ER

These historical archives are available as an add-on to one-year subscriptions.
See the Signup Form for more information.

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Endo Pharms
OPANA ER
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL021610-002Jun 22, 20065,958,456<disabled>
Endo Pharms
OPANA ER
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL021610-005Feb 29, 20085,128,143<disabled>
Endo Pharms
OPANA ER
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL021610-007Feb 29, 20085,958,456<disabled>
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

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
8,748,611Processes for preparing morphinan-6-one products with low levels of alpha beta-unsaturated compounds<disabled in preview>
8,114,384Process for the production of an abuse-proofed solid dosage form<disabled in preview>
8,420,056Abuse-proofed dosage form<disabled in preview>
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Tradename: OPANA ER

Country Document Number Estimated Expiration
Germany60223254<disabled in preview>
TaiwanI381860<disabled in preview>
Russian Federation2006106726<disabled in preview>
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

How are People Using DrugPatentWatch?

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

Connect with Social Media:

`abc