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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Medtronic
Federal Trade Commission
Healthtrust
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Cipla
Boehringer Ingelheim
Covington
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Cerilliant

Generated: November 18, 2017

DrugPatentWatch Database Preview

NICORETTE Drug Profile

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Which patents cover Nicorette, and what generic Nicorette alternatives are available?

Nicorette is a drug marketed by Glaxosmithkline and Glaxosmithkline Cons and is included in three NDAs. There are three patents protecting this drug and two Paragraph IV challenges.

This drug has forty patent family members in twenty countries.

The generic ingredient in NICORETTE is nicotine polacrilex. There are twenty-nine drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the nicotine polacrilex profile page.
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline
NICORETTE
nicotine polacrilex
GUM, CHEWING;BUCCAL018612-002Feb 9, 1996OTCYesYes► Subscribe► Subscribe ► Subscribe
Glaxosmithkline
NICORETTE
nicotine polacrilex
GUM, CHEWING;BUCCAL020066-002Feb 9, 1996OTCYesYes► Subscribe► SubscribeY ► Subscribe
Glaxosmithkline Cons
NICORETTE
nicotine polacrilex
TROCHE/LOZENGE;ORAL022360-001May 18, 2009OTCYesNo► Subscribe► SubscribeY ► Subscribe
Glaxosmithkline
NICORETTE
nicotine polacrilex
GUM, CHEWING;BUCCAL020066-004Sep 25, 2000OTCYesNo► Subscribe► Subscribe► Subscribe
Glaxosmithkline
NICORETTE
nicotine polacrilex
GUM, CHEWING;BUCCAL018612-004Sep 25, 2000OTCYesNo► Subscribe► Subscribe► Subscribe
Glaxosmithkline Cons
NICORETTE
nicotine polacrilex
TROCHE/LOZENGE;ORAL022360-001May 18, 2009OTCYesNo► Subscribe► SubscribeY ► Subscribe
Glaxosmithkline Cons
NICORETTE
nicotine polacrilex
TROCHE/LOZENGE;ORAL022360-002May 18, 2009OTCYesYes► Subscribe► SubscribeY ► Subscribe
Glaxosmithkline Cons
NICORETTE
nicotine polacrilex
TROCHE/LOZENGE;ORAL022360-002May 18, 2009OTCYesYes► Subscribe► SubscribeY ► Subscribe
Glaxosmithkline
NICORETTE (MINT)
nicotine polacrilex
GUM, CHEWING;BUCCAL020066-003Dec 23, 1998OTCYesNo► Subscribe► Subscribe► Subscribe
Glaxosmithkline
NICORETTE (MINT)
nicotine polacrilex
GUM, CHEWING;BUCCAL018612-003Dec 23, 1998OTCYesNo► Subscribe► Subscribe► Subscribe
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Expired Patents for Tradename: NICORETTE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline Cons
NICORETTE
nicotine polacrilex
TROCHE/LOZENGE;ORAL022360-001May 18, 2009► Subscribe► Subscribe
Glaxosmithkline Cons
NICORETTE
nicotine polacrilex
TROCHE/LOZENGE;ORAL022360-002May 18, 2009► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges for NICORETTE

Drugname Dosage Strength RLD Submissiondate
nicotine polacrilexGum2 mgNicorette1/22/2013
nicotine polacrilexGum4 mgNicorette1/22/2013

Non-Orange Book Patents for Tradename: NICORETTE

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 Tradename: NICORETTE

Country Document Number Estimated Expiration
New Zealand563424► Subscribe
World Intellectual Property Organization (WIPO)2006124366► Subscribe
South Korea20080037614► Subscribe
Japan2015232012► Subscribe
South Africa200710905► Subscribe
Australia2009243065► Subscribe
Australia2006247847► Subscribe
HungaryE031175► Subscribe
European Patent Office2285411► Subscribe
Portugal2285411► 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:

Accenture
Novartis
Johnson and Johnson
Colorcon
Deloitte
Federal Trade Commission
Cerilliant
Healthtrust
Farmers Insurance
Cantor Fitzgerald

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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