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Details for Patent: 8,318,788

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Patent 8,318,788 protects CONTRAVE and is included in one NDA. There has been one Paragraph IV challenge on Contrave.

This patent has twenty-seven patent family members in eighteen countries.

Summary for Patent: 8,318,788

Title:Layered pharmaceutical formulations
Abstract: In one embodiment a layered pharmaceutical formulation includes two or more pharmaceutical layers and an intermediate layer disposed between at least two of the two or more pharmaceutical layers, the intermediate layer configured to dissolve in vivo to thereby leave the two or more pharmaceutical layers substantially intact. In one embodiment, an active pharmaceutical ingredient in at least one of the pharmaceutical layers is selected from bupropion, zonisamide, naltrexone, topiramate, phentermine, metformin, olanzapine and fluoxetine.
Inventor(s): McKinney; Anthony (San Diego, CA), Tollefson; Gary (Indianapolis, IN), Weber; Eckard (San Diego, CA), Soltero; Rick (Holly Springs, NC)
Assignee: Orexigen Therapeutics, Inc. (La Jolla, CA)
Application Number:13/330,395
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation; Dosage form;
Patent Metrics:
Source: PatentQuant.com
Field: Pharmaceuticals
Back Citations: 173rd percentile
Forward Citations: 7th percentile

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Orexigen
CONTRAVE
bupropion hydrochloride; naltrexone hydrochloride
TABLET, EXTENDED RELEASE;ORAL200063-001Sep 10, 2014RXYes8,318,788► subscribe USE OF NALTREXONE AND BUPROPION IN A LAYERED FORMULATION FOR CHRONIC WEIGHT MANAGEMENT FOR AFFECTING WEIGHT LOSS
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Non-Orange Book Patents for Patent: 8,318,788

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
8,088,786Layered pharmaceutical formulations► 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: 8,318,788

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Japan2016029106► subscribe
Hong Kong1135026► subscribe
Israel198577► 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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