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Details for Patent: 8,329,216

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Patent 8,329,216 protects OPANA ER and is included in one NDA. There have been three Paragraph IV challenges on Opana ER.

This patent has forty-six patent family members in sixteen countries.

Summary for Patent: 8,329,216

Title:Oxymorphone controlled release formulations
Abstract: The invention pertains to a method of relieving pain by administering a controlled release pharmaceutical tablet containing oxymorphone which produces a mean minimum blood plasma level 12 to 24 hours after dosing, as well as the tablet producing the sustained pain relief.
Inventor(s): Kao; Haui-Hung (Syosset, NY), Baichwal; Anand R. (Wappingers Falls, NY), McCall; Troy (Smyrna, GA), Lee; David (Chadds, PA)
Assignee: Endo Pharmaceuticals Inc. (Chadds Ford, PA)
Application Number:11/427,438
Patent Claim Types:
see list of patent claims
Formulation; Compound; Dosage form; Use; Composition; Delivery;
Patent Metrics:
Source: PatentQuant.com
Field: Pharmaceuticals
Back Citations: 174th percentile
Forward Citations: 2nd percentile

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Endo Pharms
OPANA ER
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL201655-001Dec 9, 2011RXNo8,329,216► subscribeY
Endo Pharms
OPANA ER
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL201655-002Dec 9, 2011RXNo8,329,216► subscribeY
Endo Pharms
OPANA ER
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL201655-003Dec 9, 2011RXNo8,329,216► subscribeY
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Non-Orange Book Patents for Patent: 8,329,216

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
8,309,122Oxymorphone controlled release formulations► subscribe
7,276,250Sustained release formulations of oxymorphone► 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 Patent: 8,329,216

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Austria359077► subscribe
Austria376832► subscribe
Australia2002316582► 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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