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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
Formulation / Manufacturing:see details

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
Roxane
OXYMORPHONE HYDROCHLORIDE
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL200822-001Jul 15, 2013RXNo<disabled><disabled>
Endo Pharms
OPANA ER
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL201655-005Dec 9, 2011RXNo8,329,216<disabled>Y <disabled>
Endo Pharms
OPANA ER
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL201655-007Dec 9, 2011RXYes8,871,779<disabled>Y <disabled>
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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;ORAL021610-004Jun 22, 20065,662,933<disabled>
Endo Pharms
OPANA ER
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL021610-005Feb 29, 20085,958,456<disabled>
Endo Pharms
OPANA ER
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL021610-003Jun 22, 20065,662,933<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>
8,323,889Process for the production of an abuse-proofed solid dosage form<disabled in preview>
8,420,056Abuse-proofed 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
European Patent Office1658055<disabled in preview>
European Patent Office2311460<disabled in preview>
Slovenia1658055<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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