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Serving leading biopharmaceutical companies globally:

Accenture
Mallinckrodt
Daiichi Sankyo
Chinese Patent Office
Deloitte
QuintilesIMS
Cantor Fitzgerald
Julphar
Dow
Queensland Health

Generated: December 13, 2017

DrugPatentWatch Database Preview

OPANA ER Drug Profile

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Which patents cover Opana Er, and when can generic versions of Opana Er launch?

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

This drug has two hundred and forty-one patent family members in thirty-two countries.

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

Pharmacology for OPANA ER

Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists

Medical Subject Heading (MeSH) Categories for OPANA ER

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Endo PharmsOPANA ERoxymorphone hydrochlorideTABLET, EXTENDED RELEASE;ORAL021610-003Jun 22, 2006DISCNNoNo► Subscribe► Subscribe► SubscribeY► Subscribe
Endo PharmsOPANA ERoxymorphone hydrochlorideTABLET, EXTENDED RELEASE;ORAL201655-004Dec 9, 2011DISCNYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Endo PharmsOPANA ERoxymorphone hydrochlorideTABLET, EXTENDED RELEASE;ORAL201655-005Dec 9, 2011DISCNYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Endo PharmsOPANA ERoxymorphone hydrochlorideTABLET, EXTENDED RELEASE;ORAL201655-006Dec 9, 2011DISCNYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Endo PharmsOPANA ERoxymorphone hydrochlorideTABLET, EXTENDED RELEASE;ORAL201655-005Dec 9, 2011DISCNYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Endo PharmsOPANA ERoxymorphone hydrochlorideTABLET, EXTENDED RELEASE;ORAL201655-005Dec 9, 2011DISCNYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Endo PharmsOPANA ERoxymorphone hydrochlorideTABLET, EXTENDED RELEASE;ORAL201655-006Dec 9, 2011DISCNYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Endo PharmsOPANA ERoxymorphone hydrochlorideTABLET, EXTENDED RELEASE;ORAL021610-004Jun 22, 2006DISCNNoNo► Subscribe► Subscribe► SubscribeY► Subscribe
Endo PharmsOPANA ERoxymorphone hydrochlorideTABLET, EXTENDED RELEASE;ORAL201655-003Dec 9, 2011DISCNYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Endo PharmsOPANA ERoxymorphone hydrochlorideTABLET, EXTENDED RELEASE;ORAL201655-004Dec 9, 2011DISCNYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
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Expired Patents for Tradename: OPANA ER

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Endo PharmsOPANA ERoxymorphone hydrochlorideTABLET, EXTENDED RELEASE;ORAL021610-004Jun 22, 2006► Subscribe► Subscribe
Endo PharmsOPANA ERoxymorphone hydrochlorideTABLET, EXTENDED RELEASE;ORAL021610-007Feb 29, 2008► Subscribe► Subscribe
Endo PharmsOPANA ERoxymorphone hydrochlorideTABLET, EXTENDED RELEASE;ORAL021610-002Jun 22, 2006► Subscribe► Subscribe
Endo PharmsOPANA ERoxymorphone hydrochlorideTABLET, EXTENDED RELEASE;ORAL021610-004Jun 22, 2006► Subscribe► Subscribe
Endo PharmsOPANA ERoxymorphone hydrochlorideTABLET, EXTENDED RELEASE;ORAL021610-003Jun 22, 2006► Subscribe► Subscribe
Endo PharmsOPANA ERoxymorphone hydrochlorideTABLET, EXTENDED RELEASE;ORAL021610-006Feb 29, 2008► Subscribe► Subscribe
Endo PharmsOPANA ERoxymorphone hydrochlorideTABLET, EXTENDED RELEASE;ORAL021610-001Jun 22, 2006► Subscribe► Subscribe
Endo PharmsOPANA ERoxymorphone hydrochlorideTABLET, EXTENDED RELEASE;ORAL021610-002Jun 22, 2006► Subscribe► Subscribe
Endo PharmsOPANA ERoxymorphone hydrochlorideTABLET, EXTENDED RELEASE;ORAL021610-007Feb 29, 2008► Subscribe► Subscribe
Endo PharmsOPANA ERoxymorphone hydrochlorideTABLET, EXTENDED RELEASE;ORAL021610-003Jun 22, 2006► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges 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 Tablets20 mg, 30 mg, 40 mgOpana ER (NDA 201655)4/3/2012
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► Subscribe
9,820,982Oxymorphone controlled release formulations► Subscribe
9,789,103Method of treating pain utilizing controlled release oxymorphone pharmaceutical compositions and instruction on dosing for renal impairment► Subscribe
8,420,056Abuse-proofed dosage form► Subscribe
9,629,807Abuse-proofed dosage form► Subscribe
8,323,889Process for the production of an abuse-proofed solid dosage form► Subscribe
8,114,384Process for the production of an abuse-proofed solid dosage form► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: OPANA ER

Country Document Number Estimated Expiration
Germany60223254► Subscribe
EcuadorSP066346► Subscribe
Portugal1658054► Subscribe
World Intellectual Property Organization (WIPO)03004033► Subscribe
Germany502004003234► Subscribe
CroatiaP20130453► Subscribe
Mexico337864► Subscribe
Slovenia1658055► Subscribe
Norway20031019► Subscribe
New Zealand560203► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Merck
QuintilesIMS
Johnson and Johnson
US Army
Baxter
Fish and Richardson
Deloitte
Novartis
Cantor Fitzgerald

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 data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. 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.

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