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Serving leading biopharmaceutical companies globally:

Colorcon
Chubb
Johnson and Johnson
McKinsey
Express Scripts
Fuji
Novartis
Covington
Queensland Health
Dow

Generated: October 21, 2017

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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 Avanthi Inc, Sun Pharm Inds Ltd, Endo Pharms, Mallinckrodt Inc, West-ward Pharms Int, Teva, Actavis Elizabeth, Aurolife Pharma Llc, Impax Labs, Epic Pharma Llc, and Par Pharm, 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 patent family members in thirty-two countries.

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

Summary for Generic Name: oxymorphone hydrochloride

US Patents:10
Tradenames:4
Applicants:11
NDAs:17
Drug Master File Entries: see list9
Suppliers / Packagers: see list19
Bulk Api Vendors: see list18
Clinical Trials: see list2,307
Patent Applications: see list4,951
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:oxymorphone hydrochloride at DailyMed

Pharmacology for Ingredient: oxymorphone hydrochloride

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
Par Pharm
OXYMORPHONE HYDROCHLORIDE
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL200792-007Oct 24, 2014DISCNNoNo► Subscribe► Subscribe► Subscribe
Endo Pharms
OPANA ER
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL201655-004Dec 9, 2011DISCNYesNo► Subscribe► SubscribeY ► Subscribe
Endo Pharms
OPANA ER
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL201655-005Dec 9, 2011DISCNYesNo► Subscribe► SubscribeY ► Subscribe
Par Pharm
OXYMORPHONE HYDROCHLORIDE
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL200792-003Oct 24, 2014DISCNNoNo► Subscribe► Subscribe► Subscribe
Endo Pharms
OPANA ER
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL201655-006Dec 9, 2011DISCNYesNo► Subscribe► Subscribe ► Subscribe
Endo Pharms
OPANA ER
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL201655-005Dec 9, 2011DISCNYesNo► Subscribe► SubscribeY ► Subscribe
Sun Pharm Inds Ltd
OXYMORPHONE HYDROCHLORIDE
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL203506-001Apr 24, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Par Pharm
OXYMORPHONE HYDROCHLORIDE
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL200792-004Oct 24, 2014DISCNNoNo► Subscribe► Subscribe► Subscribe
Mallinckrodt Inc
OXYMORPHONE HYDROCHLORIDE
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL202946-006Jun 27, 2014ABRXNoNo► Subscribe► Subscribe► Subscribe
Aurolife Pharma Llc
OXYMORPHONE HYDROCHLORIDE
oxymorphone hydrochloride
TABLET;ORAL204459-002Apr 26, 2016ABRXNoNo► Subscribe► Subscribe► 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 Pharms
OPANA ER
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL021610-005Feb 29, 2008► Subscribe► Subscribe
Endo Pharms
OPANA ER
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL021610-007Feb 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;ORAL021610-003Jun 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;ORAL021610-001Jun 22, 2006► Subscribe► Subscribe
Endo Pharms
OPANA ER
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL021610-002Jun 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;ORAL021610-003Jun 22, 2006► Subscribe► Subscribe
Endo Pharms
OPANA ER
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL021610-002Jun 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
8,114,384Process for the production of an abuse-proofed solid dosage form► Subscribe
8,748,611Processes for preparing morphinan-6-one products with low levels of alpha beta-unsaturated compounds► 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
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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
Denmark1658055► Subscribe
Austria447942► Subscribe
Australia2004264666► Subscribe
Peru07282005► Subscribe
Germany502004003234► Subscribe
New Zealand560203► Subscribe
SloveniaEP1842533► Subscribe
Australia2002316582► Subscribe
South Korea101266925► Subscribe
European Patent Office1842533► 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:

Baxter
Merck
US Department of Justice
McKinsey
QuintilesIMS
Chubb
McKesson
Dow
Federal Trade Commission
Queensland Health

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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