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Generated: July 28, 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 thirty-three patent family members in eighteen 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.

Summary for Tradename: NICORETTE

Patents:3
Applicants:2
NDAs:3
Suppliers / Packagers: see list4
Bulk Api Vendors: see list51
Clinical Trials: see list31
Patent Applications: see list9,550
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:NICORETTE at DailyMed
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
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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 activity 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
Hong Kong1197195► Subscribe
Japan2008540649► Subscribe
BrazilPI0611520► Subscribe
Japan2015232012► Subscribe
Russian Federation2458692► 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 500+ biopharmaceutical companies globally:

Federal Trade Commission
Merck
Boehringer Ingelheim
Julphar
Medtronic
Healthtrust
AstraZeneca
Dow
UBS
Cerilliant

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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