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Serving leading biopharmaceutical companies globally:

Novartis
Deloitte
Julphar
Cipla
Argus Health
McKinsey
Teva
Cerilliant
Merck
Cantor Fitzgerald

Generated: November 24, 2017

DrugPatentWatch Database Preview

Details for Patent: 8,318,788

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Which drugs does patent 8,318,788 protect, and when does it expire?


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

This patent has thirty-one 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;

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Orexigen
CONTRAVE
bupropion hydrochloride; naltrexone hydrochloride
TABLET, EXTENDED RELEASE;ORAL200063-001Sep 10, 2014RXYesYes► Subscribe► 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
Taiwan200829288► Subscribe
Russian Federation2452471► Subscribe
Russian Federation2009116835► Subscribe
Mexico2009004874► Subscribe
South Korea20170002660► Subscribe
South Korea101735466► Subscribe
South Korea20140101443► Subscribe
South Korea101654176► Subscribe
South Korea20150046390► Subscribe
South Korea101479324► 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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Serving leading biopharmaceutical companies globally:

Argus Health
Cantor Fitzgerald
Mallinckrodt
McKinsey
Novartis
US Department of Justice
UBS
Federal Trade Commission
Fish and Richardson
Chubb

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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