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Oxymorphone hydrochloride - Generic Drug Details

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Oxymorphone hydrochloride is the generic ingredient in four branded drugs marketed by Avanthi Inc, Sun Pharm Inds Ltd, Endo Pharms, Mallinckrodt Inc, Roxane, Teva, Actavis Elizabeth, Aurolife Pharma Llc, Impax Labs, Corepharma, 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.

This ingredient has one hundred and ninety-six patent family members in thirty countries.

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

Summary for Generic Name: oxymorphone hydrochloride

Tradenames:4
Patents:10
Applicants:11
NDAs:17
Drug Master File Entries: see list9
Suppliers / Packaging: see list18
Therapeutic Class:Analgesics
Drug Prices:see low prices

Pharmacology for Ingredient: oxymorphone hydrochloride

Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists

Clinical Trials for: oxymorphone hydrochloride

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;ORAL201655-005Dec 9, 2011RXNo8,309,122Feb 4, 2023Y
Mallinckrodt Inc
OXYMORPHONE HYDROCHLORIDE
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL202946-005Jun 27, 2014RXNo
Actavis Elizabeth
OXYMORPHONE HYDROCHLORIDE
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL079046-004Jul 11, 2013RXNo
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Expired Orange Book Patents for Generic Ingredient: oxymorphone hydrochloride

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Endo Pharms
OPANA ER
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL021610-007Feb 29, 20085,958,456<disabled>
Endo Pharms
OPANA ER
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL021610-005Feb 29, 20085,662,933<disabled>
Endo Pharms
OPANA ER
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL021610-001Jun 22, 20065,128,143<disabled>
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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
8,748,611Processes 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>
8,323,889Process for the production of an abuse-proofed solid dosage form<disabled in preview>
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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
Norway326375<disabled in preview>
Japan2005520778<disabled in preview>
Russian Federation2461381<disabled in preview>
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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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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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