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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
US Department of Justice
Citi
Colorcon
McKesson
Dow
QuintilesIMS
Cipla
UBS
Teva

Generated: December 11, 2017

DrugPatentWatch Database Preview

Details for Patent: 8,323,683

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Which drugs does patent 8,323,683 protect, and when does it expire?


Patent 8,323,683 protects NICORETTE and is included in two NDAs. There have been two Paragraph IV challenges on Nicorette.

This patent has nineteen patent family members in sixteen countries.

Summary for Patent: 8,323,683

Title:Flavoring of drug-containing chewing gums
Abstract: A chewing gum comprising at least one active pharmaceutical ingredient (API) with a core onto which is applied at least one inner polymer film coating and thereafter onto which is applied at least one outer hard coating. A preferred API is nicotine. Flavoring agents may be incorporated in the core, in the at least one inner polymer film coating and/or in the at least one outer hard coating. The gums formed exhibit a long lasting effect of flavoring agent(s) and result in the domination of flavoring agents in the coating(s) over flavoring agent(s) in the core, thereby (a) avoiding problems of chemical or pharmaceutical incompatibility between an API in the core and flavoring agent(s) in the coating(s) and (b) achieving an increased control of the release of the API and of non-active excipients.
Inventor(s): Mody; Seema (Montville, NJ), Koll; Gregory (Hillsborough, NJ)
Assignee: McNeil-PPC, Inc. (Skillman, NJ)
Application Number:11/131,561
Patent Claim Types:
see list of patent claims
Compound;

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Patented / Exclusive Use
GlaxosmithklineNICORETTEnicotine polacrilexGUM, CHEWING;BUCCAL018612-002Feb 9, 1996OTCYesYes► Subscribe► Subscribe► Subscribe
GlaxosmithklineNICORETTEnicotine polacrilexGUM, CHEWING;BUCCAL020066-002Feb 9, 1996OTCYesYes► Subscribe► Subscribe► SubscribeY
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Non-Orange Book Patents for Patent: 8,323,683

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
8,658,200Flavoring of drug-containing chewing gums► 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: 8,323,683

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Taiwan200719915► Subscribe
Russian Federation2429827► Subscribe
Russian Federation2007146992► Subscribe
New Zealand563424► Subscribe
South Korea20080037614► Subscribe
Japan5627851► Subscribe
Japan2008540649► Subscribe
Hong Kong1197195► Subscribe
Hong Kong1114767► Subscribe
Spain2516650► 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:

Chinese Patent Office
Chubb
Argus Health
Cerilliant
Cipla
UBS
Julphar
Fish and Richardson
Covington
Deloitte

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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