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Serving 500+ biopharmaceutical companies globally:

Accenture
Cipla
Chubb
Fish and Richardson
Covington
Federal Trade Commission
Dow
Boehringer Ingelheim
Daiichi Sankyo
Express Scripts

Generated: June 26, 2017

DrugPatentWatch Database Preview

Nicotine polacrilex - Generic Drug Details

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What are the generic drug sources for nicotine polacrilex and what is the scope of nicotine polacrilex patent protection?

Nicotine polacrilex
is the generic ingredient in five branded drugs marketed by Actavis Labs Ny Inc, Perrigo R And D, Glaxosmithkline, Glaxosmithkline Cons, Watson Labs, Ivax Sub Teva Pharms, Novartis, and L Perrigo Co, and is included in forty NDAs. There are four patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Nicotine polacrilex has thirty-three patent family members in eighteen countries.

There are twenty-nine drug master file entries for nicotine polacrilex. Forty-five suppliers are listed for this compound.

Summary for Generic Name: nicotine polacrilex

Tradenames:5
Patents:4
Applicants:8
NDAs:40
Drug Master File Entries: see list29
Suppliers / Packagers: see list45
Bulk Api Vendors: see list50
Clinical Trials: see list673
Patent Applications: see list8,584
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:nicotine polacrilex at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
L Perrigo Co
NICOTINE POLACRILEX
nicotine polacrilex
GUM, CHEWING;BUCCAL076775-001Sep 16, 2004OTCNoNo► Subscribe► Subscribe
Perrigo R And D
NICOTINE POLACRILEX
nicotine polacrilex
GUM, CHEWING;BUCCAL206394-001Dec 15, 2016OTCNoNo► Subscribe► Subscribe
Actavis Labs Ny Inc
NICOTINE POLACRILEX
nicotine polacrilex
GUM, CHEWING;BUCCAL076568-002Jul 29, 2004OTCNoNo► Subscribe► Subscribe
Actavis Labs Ny Inc
NICOTINE POLACRILEX
nicotine polacrilex
GUM, CHEWING;BUCCAL078697-001Dec 29, 2008OTCNoNo► Subscribe► Subscribe
L Perrigo Co
NICOTINE POLACRILEX
nicotine polacrilex
GUM, CHEWING;BUCCAL076779-001Sep 16, 2004OTCNoNo► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: nicotine polacrilex

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline Cons
COMMIT
nicotine polacrilex
TROCHE/LOZENGE;ORAL021330-001Oct 31, 20025,110,605► Subscribe
Glaxosmithkline Cons
NICORETTE
nicotine polacrilex
TROCHE/LOZENGE;ORAL022360-001May 18, 20095,110,605► Subscribe
Glaxosmithkline Cons
NICORETTE
nicotine polacrilex
TROCHE/LOZENGE;ORAL022360-002May 18, 20095,110,605► Subscribe
Glaxosmithkline Cons
COMMIT
nicotine polacrilex
TROCHE/LOZENGE;ORAL021330-002Oct 31, 20025,110,605► Subscribe
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Non-Orange Book Patents for Generic Ingredient: nicotine polacrilex

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 Ingredient: nicotine polacrilex

Country Document Number Estimated Expiration
Japan2015232012► Subscribe
Russian Federation2010149050► Subscribe
South Africa200710905► Subscribe
BrazilPI0911847► Subscribe
Argentina053731► 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:

McKesson
Deloitte
Federal Trade Commission
Argus Health
Johnson and Johnson
Cantor Fitzgerald
QuintilesIMS
Baxter
Chinese Patent Office
Cipla

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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