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Nicotine - Generic Drug Details

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

Nicotine is the generic ingredient in ten branded drugs marketed by Aveva, Pharmacia And Upjohn, Mcneil Cons, Sanofi Aventis Us, Dr Reddys Labs Inc, Pfizer Inc, 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-seven NDAs. There are seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has twenty-eight patent family members in twenty-three countries.

There are twenty-nine drug master file entries for nicotine. Thirty-one suppliers are listed for this compound.

Summary for Generic Name: nicotine

Tradenames:10
Patents:8
Applicants:14
NDAs:47
Drug Master File Entries: see list29
Suppliers / Packagers: see list31
Bulk Api Vendors: see list50
Clinical Trials: see list302
Patent Applications: see list9,294
Therapeutic Class:Antidotes, Deterrents, and Toxicologic Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:nicotine at DailyMed

Pharmacology for Ingredient: nicotine

Ingredient-typeNicotine
Drug ClassCholinergic Nicotinic Agonist
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Actavis Labs Ny Inc
NICOTINE POLACRILEX
nicotine polacrilex
GUM, CHEWING;BUCCAL204833-001Feb 26, 2016OTCNoNo► Subscribe► Subscribe
Glaxosmithkline
NICORETTE
nicotine polacrilex
GUM, CHEWING;BUCCAL020066-002Feb 9, 1996OTCYesYes8,323,683► SubscribeY ► Subscribe
Perrigo R And D
NICOTINE POLACRILEX
nicotine polacrilex
TROCHE/LOZENGE;ORAL203690-001Oct 9, 2012OTCNoNo► Subscribe► Subscribe
Actavis Labs Ny Inc
NICOTINE POLACRILEX
nicotine polacrilex
GUM, CHEWING;BUCCAL079038-001Jul 8, 2009OTCNoNo► Subscribe► Subscribe
Perrigo R And D
NICOTINE POLACRILEX
nicotine polacrilex
GUM, CHEWING;BUCCAL206394-001Dec 15, 2016OTCNoNo► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: nicotine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mcneil Cons
NICOTROL
nicotine
FILM, EXTENDED RELEASE;TRANSDERMAL020536-001Jul 3, 19965,501,236► Subscribe
Mcneil Cons
NICOTROL
nicotine
FILM, EXTENDED RELEASE;TRANSDERMAL020536-001Jul 3, 19966,098,632► Subscribe
Dr Reddys Labs Inc
HABITROL
nicotine
FILM, EXTENDED RELEASE;TRANSDERMAL020076-005Nov 12, 19995,834,011► Subscribe
Sanofi Aventis Us
NICODERM CQ
nicotine
FILM, EXTENDED RELEASE;TRANSDERMAL020165-004Aug 2, 19965,364,630► Subscribe
Sanofi Aventis Us
NICODERM CQ
nicotine
FILM, EXTENDED RELEASE;TRANSDERMAL020165-004Aug 2, 19965,633,008► Subscribe
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Non-Orange Book Patents for Generic Ingredient: nicotine

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
7,622,136Transparent transdermal nicotine delivery devices► 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

Country Document Number Estimated Expiration
Cyprus1110643► Subscribe
Norway20013012► Subscribe
World Intellectual Property Organization (WIPO)0037058► Subscribe
Hungary0104728► Subscribe
China1331586► 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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