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Details for Patent: 8,192,722

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Patent 8,192,722 protects OPANA ER and is included in one NDA. There have been three Paragraph IV challenges on Opana ER.

This patent has one hundred and twenty-three patent family members in twenty-eight countries.

Summary for Patent: 8,192,722

Title:Abuse-proof dosage form
Abstract: The invention relates to a dosage form that is thermoformed without discoloration and is safeguarded from abuse, comprising at least one synthetic or natural polymer having a breaking strength of at least 500 N in addition to one or more active substances that could be subject to abuse. The invention also relates to a corresponding method for producing said dosage form.
Inventor(s): Arkenau-Maric; Elisabeth (Koln, DE), Bartholomaus; Johannes (Aachen, DE), Kugelmann; Heinrich (Aachen, DE)
Assignee: Grunenthal GmbH (Aachen, DE)
Application Number:12/140,665
Patent Claim Types:
see list of patent claims
Compound; Dosage form; Composition; Process;
Patent Metrics:
Source: PatentQuant.com
Field: Pharmaceuticals
Back Citations: 395th percentile
Forward Citations: 26th 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, 2011RXNo8,192,722► subscribeY
Endo Pharms
OPANA ER
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL201655-002Dec 9, 2011RXNo8,192,722► subscribeY
Endo Pharms
OPANA ER
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL201655-003Dec 9, 2011RXNo8,192,722► subscribeY
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Non-Orange Book Patents for Patent: 8,192,722

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
8,420,056Abuse-proofed dosage form► subscribe
8,114,383Abuse-proofed 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 Patent: 8,192,722

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina045352► subscribe
Argentina045353► subscribe
Argentina046994► 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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