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Serving 500+ biopharmaceutical companies globally:

Teva
Queensland Health
Novartis
Moodys
Deloitte
Harvard Business School
Cerilliant
Covington
Johnson and Johnson
Dow

Generated: July 27, 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 five patent family members in thirty-one countries.

The generic ingredient in OPANA ER is oxymorphone hydrochloride. There are nine drug master file entries for this compound. Twenty 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 list6
Bulk Api Vendors: see list18
Clinical Trials: see list8
Patent Applications: see list4,341
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:OPANA ER at DailyMed

Pharmacology for Tradename: OPANA ER

Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Endo Pharms
OPANA ER
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL201655-004Dec 9, 2011RXYesNo► Subscribe► SubscribeY ► Subscribe
Endo Pharms
OPANA ER
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL201655-003Dec 9, 2011RXYesNo► Subscribe► SubscribeY ► Subscribe
Endo Pharms
OPANA ER
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL201655-005Dec 9, 2011RXYesNo► Subscribe► SubscribeY ► Subscribe
Endo Pharms
OPANA ER
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL201655-006Dec 9, 2011RXYesNo► Subscribe► SubscribeY ► Subscribe
Endo Pharms
OPANA ER
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL201655-005Dec 9, 2011RXYesNo► 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 Pharms
OPANA ER
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL021610-005Feb 29, 2008► Subscribe► Subscribe
Endo Pharms
OPANA ER
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL021610-003Jun 22, 2006► Subscribe► Subscribe
Endo Pharms
OPANA ER
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL021610-004Jun 22, 2006► Subscribe► Subscribe
Endo Pharms
OPANA ER
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL021610-006Feb 29, 2008► Subscribe► Subscribe
Endo Pharms
OPANA ER
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL021610-007Feb 29, 2008► Subscribe► Subscribe
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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 Tablets5 mgOpana ER (NDA 201655)3/26/2012
oxymorphone hydrochlorideExtended-release Tablets7.5 mg, 10 mg, and 15 mgOpana ER (NDA 201655)3/23/2012
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
8,114,384Process for the production of an abuse-proofed solid dosage form► Subscribe
8,420,056Abuse-proofed dosage form► Subscribe
9,629,807Abuse-proofed dosage form► Subscribe
8,748,611Processes for preparing morphinan-6-one products with low levels of alpha beta-unsaturated compounds► Subscribe
8,323,889Process 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
South Korea20120104199► Subscribe
China102391271► Subscribe
Russian Federation2399371► Subscribe
World Intellectual Property Organization (WIPO)2005063214► Subscribe
Canada2595954► 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 500+ biopharmaceutical companies globally:

US Army
US Department of Justice
Deloitte
Teva
Cantor Fitzgerald
Argus Health
Colorcon
Federal Trade Commission
Julphar
AstraZeneca

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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