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Nicotine polacrilex - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for nicotine polacrilex?

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 Perrigo, and is included in forty NDAs. There are three patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has thirty-one patent family members in sixteen 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 list301
Patent Applications: see list8,398
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:nicotine polacrilex at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline
NICORETTE
nicotine polacrilex
GUM, CHEWING;BUCCAL018612-002Feb 9, 1996OTCYesYes8,323,683► Subscribe ► Subscribe
Perrigo R And D
NICOTINE POLACRILEX
nicotine polacrilex
TROCHE/LOZENGE;ORAL203690-002Oct 9, 2012OTCNoNo► Subscribe► Subscribe
Actavis Labs Ny Inc
NICOTINE POLACRILEX
nicotine polacrilex
GUM, CHEWING;BUCCAL204833-001Feb 26, 2016OTCNoNo► Subscribe► Subscribe
Perrigo R And D
NICOTINE POLACRILEX
nicotine polacrilex
GUM, CHEWING;BUCCAL078326-001Oct 30, 2006OTCNoNo► Subscribe► Subscribe
Glaxosmithkline
NICORETTE
nicotine polacrilex
GUM, CHEWING;BUCCAL020066-002Feb 9, 1996OTCYesYes8,323,683► SubscribeY ► 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
COMMIT
nicotine polacrilex
TROCHE/LOZENGE;ORAL021330-002Oct 31, 20025,110,605► Subscribe
Glaxosmithkline Cons
NICORETTE
nicotine polacrilex
TROCHE/LOZENGE;ORAL022360-002May 18, 20095,110,605► Subscribe
Glaxosmithkline Cons
NICORETTE
nicotine polacrilex
TROCHE/LOZENGE;ORAL022360-001May 18, 20095,110,605► 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
Japan2008540649► Subscribe
BrazilPI0611520► Subscribe
China101222915► Subscribe
Australia2006247847► Subscribe
Denmark1888042► 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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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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