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Details for Patent: 8,323,683

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

This patent has eighteen patent family members in fifteen 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;
Patent Metrics:
Source: PatentQuant.com
Field: Other consumer goods
Back Citations: 38th percentile
Forward Citations: 3rd percentile

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Glaxosmithkline
NICORETTE
nicotine polacrilex
GUM, CHEWING;BUCCAL018612-002Feb 9, 1996OTCYes8,323,683► subscribe
Glaxosmithkline
NICORETTE
nicotine polacrilex
GUM, CHEWING;BUCCAL020066-002Feb 9, 1996OTCYes8,323,683► 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
Argentina053731► subscribe
Australia2006247847► subscribe
BrazilPI0611520► 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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