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Details for Patent: 8,501,164

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Which drugs does patent 8,501,164 protect, and when does it expire?

Patent 8,501,164 protects NICORETTE and is included in one NDA. There have been two Paragraph IV challenges on Nicorette.

This patent has thirteen patent family members in eleven countries.

Summary for Patent: 8,501,164

Title:Nicotine lozenge compositions
Abstract: The present invention relates to nicotine lozenge compositions comprising reduced levels of buffering agents from traditional nicotine lozenges and which provide optimal oral pH and prompt nicotine absorption in a smaller, more convenient dosage form.
Inventor(s): Chen; Li-Lan (Parsippany, NJ)
Assignee: GlaxoSmithKline, LLC (Philadelphia, PA)
Application Number:12/990,049
Patent Claim Types:
see list of patent claims
Composition; Formulation; Dosage form; Process;

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Glaxosmithkline Cons
NICORETTE
nicotine polacrilex
TROCHE/LOZENGE;ORAL022360-001May 18, 2009OTCYesNo8,501,164► SubscribeY
Glaxosmithkline Cons
NICORETTE
nicotine polacrilex
TROCHE/LOZENGE;ORAL022360-002May 18, 2009OTCYesYes8,501,164► SubscribeY
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Foreign Priority and PCT Information for Patent: 8,501,164

PCT Information
PCT FiledApril 30, 2009PCT Application Number:PCT/US2009/042190
PCT Publication Date:November 05, 2009PCT Publication Number: WO2009/134947

Non-Orange Book Patents for Patent: 8,501,164

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
8,940,772Nicotine lozenge composition► 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: 8,501,164

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina071420► Subscribe
Australia2009243065► Subscribe
BrazilPI0911847► Subscribe
Canada2723011► Subscribe
China102076362► 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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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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