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BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Argus Health
Covington
AstraZeneca
Accenture
Express Scripts
Merck
Chubb
Harvard Business School
Moodys

Generated: December 16, 2017

DrugPatentWatch Database Preview

Oxymorphone hydrochloride - Generic Drug Details

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What are the generic sources for oxymorphone hydrochloride and what is the scope of oxymorphone hydrochloride freedom to operate?

Oxymorphone hydrochloride
is the generic ingredient in four branded drugs marketed by Endo Pharms, Actavis Elizabeth, Impax Labs, Mallinckrodt Inc, Par Pharm, Sun Pharm Inds Ltd, West-ward Pharms Int, Aurolife Pharma Llc, Avanthi Inc, Epic Pharma Llc, and Teva, and is included in seventeen NDAs. There are ten patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Oxymorphone hydrochloride has two hundred and forty-one patent family members in thirty-two countries.

There are nine drug master file entries for oxymorphone hydrochloride. Nineteen suppliers are listed for this compound.

Pharmacology for oxymorphone hydrochloride

Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists

Medical Subject Heading (MeSH) Categories for oxymorphone hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
West-ward Pharms IntOXYMORPHONE HYDROCHLORIDEoxymorphone hydrochlorideTABLET;ORAL090964-002Sep 27, 2010ABRXNoNo► Subscribe► Subscribe► Subscribe
Endo PharmsOPANA ERoxymorphone hydrochlorideTABLET, EXTENDED RELEASE;ORAL201655-001Dec 9, 2011DISCNYesNo► Subscribe► SubscribeY► Subscribe
Sun Pharm Inds LtdOXYMORPHONE HYDROCHLORIDEoxymorphone hydrochlorideTABLET, EXTENDED RELEASE;ORAL203506-001Apr 24, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Endo PharmsOPANA ERoxymorphone hydrochlorideTABLET, EXTENDED RELEASE;ORAL201655-001Dec 9, 2011DISCNYesNo► Subscribe► SubscribeY► Subscribe
Endo PharmsOPANA ERoxymorphone hydrochlorideTABLET, EXTENDED RELEASE;ORAL201655-001Dec 9, 2011DISCNYesNo► Subscribe► SubscribeY► Subscribe
Endo PharmsOPANA ERoxymorphone hydrochlorideTABLET, EXTENDED RELEASE;ORAL201655-005Dec 9, 2011DISCNYesNo► Subscribe► Subscribe► Subscribe
Endo PharmsOPANA ERoxymorphone hydrochlorideTABLET, EXTENDED RELEASE;ORAL201655-001Dec 9, 2011DISCNYesNo► Subscribe► SubscribeY► Subscribe
Endo PharmsOPANA ERoxymorphone hydrochlorideTABLET, EXTENDED RELEASE;ORAL201655-004Dec 9, 2011DISCNYesNo► Subscribe► SubscribeY► Subscribe
Endo PharmsOPANA ERoxymorphone hydrochlorideTABLET, EXTENDED RELEASE;ORAL201655-001Dec 9, 2011DISCNYesNo► Subscribe► SubscribeY► Subscribe
Endo PharmsOPANA ERoxymorphone hydrochlorideTABLET, EXTENDED RELEASE;ORAL201655-001Dec 9, 2011DISCNYesNo► Subscribe► SubscribeY► Subscribe
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Expired Orange Book Patents for Generic Ingredient: oxymorphone hydrochloride

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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Non-Orange Book Patents for Generic Ingredient: oxymorphone hydrochloride

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
9,789,103Method of treating pain utilizing controlled release oxymorphone pharmaceutical compositions and instruction on dosing for renal impairment► Subscribe
9,820,982Oxymorphone controlled release formulations► Subscribe
8,420,056Abuse-proofed dosage form► Subscribe
8,748,611Processes for preparing morphinan-6-one products with low levels of alpha beta-unsaturated compounds► 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 Ingredient: oxymorphone hydrochloride

Country Document Number Estimated Expiration
Peru04822006► Subscribe
Japan2013173765► Subscribe
Denmark1658054► Subscribe
Spain2572166► Subscribe
Japan4895821► Subscribe
Brazil0210855► Subscribe
Chile2004002016► Subscribe
Canada2452871► Subscribe
Brazil0205722► Subscribe
World Intellectual Property Organization (WIPO)03004033► 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:

Citi
McKinsey
Medtronic
Mallinckrodt
Colorcon
Baxter
UBS
Accenture
Federal Trade Commission
Novartis

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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