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Serving leading biopharmaceutical companies globally:

Novartis
Johnson and Johnson
Boehringer Ingelheim
Covington
Cerilliant
Federal Trade Commission
QuintilesIMS
Express Scripts
McKinsey
McKesson

Generated: October 23, 2017

DrugPatentWatch Database Preview

Nicotine - Generic Drug Details

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What are the generic drug sources for nicotine and what is the scope of nicotine freedom to operate?

Nicotine
is the generic ingredient in ten branded drugs marketed by Aveva, Pharmacia And Upjohn, Mcneil Cons, Sanofi Aventis Us, Dr Reddys Labs Sa, Pfizer Inc, 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-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.

Nicotine has thirty patent family members in twenty-three countries.

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

Summary for Generic Name: nicotine

US Patents:7
Tradenames:10
Applicants:14
NDAs:47
Drug Master File Entries: see list29
Suppliers / Packagers: see list32
Bulk Api Vendors: see list50
Clinical Trials: see list686
Patent Applications: see list9,544
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 TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Perrigo R And D
NICOTINE POLACRILEX
nicotine polacrilex
TROCHE/LOZENGE;ORAL090821-002Jul 10, 2009OTCNoNo► Subscribe► Subscribe► Subscribe
Aveva
PROSTEP
nicotine
FILM, EXTENDED RELEASE;TRANSDERMAL019983-004Dec 23, 1998DISCNNoNo► Subscribe► Subscribe► Subscribe
Actavis Labs Ny Inc
NICOTINE POLACRILEX
nicotine polacrilex
GUM, CHEWING;BUCCAL074707-001Mar 19, 1999OTCNoNo► Subscribe► Subscribe► Subscribe
Sanofi Aventis Us
NICODERM CQ
nicotine
FILM, EXTENDED RELEASE;TRANSDERMAL020165-006Aug 2, 1996OTCYesNo► Subscribe► SubscribeY ► Subscribe
Aveva
NICOTINE
nicotine
FILM, EXTENDED RELEASE;TRANSDERMAL074612-001Oct 20, 1997OTCNoNo► Subscribe► Subscribe► Subscribe
Perrigo R And D
NICOTINE POLACRILEX
nicotine polacrilex
TROCHE/LOZENGE;ORAL203690-001Oct 9, 2012OTCNoNo► Subscribe► Subscribe► Subscribe
Actavis Labs Ny Inc
NICOTINE POLACRILEX
nicotine polacrilex
GUM, CHEWING;BUCCAL078697-001Dec 29, 2008OTCNoNo► Subscribe► Subscribe► Subscribe
Perrigo R And D
NICOTINE POLACRILEX
nicotine polacrilex
TROCHE/LOZENGE;ORAL203690-002Oct 9, 2012OTCNoNo► Subscribe► Subscribe► Subscribe
Perrigo R And D
NICOTINE POLACRILEX
nicotine polacrilex
GUM, CHEWING;BUCCAL078325-001Oct 30, 2006OTCNoNo► Subscribe► Subscribe► Subscribe
Actavis Labs Ny Inc
NICOTINE POLACRILEX
nicotine polacrilex
GUM, CHEWING;BUCCAL204794-001May 10, 2016OTCNoNo► Subscribe► 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
Dr Reddys Labs Sa
HABITROL
nicotine
FILM, EXTENDED RELEASE;TRANSDERMAL020076-004Nov 12, 1999► Subscribe► Subscribe
Dr Reddys Labs Sa
HABITROL
nicotine
FILM, EXTENDED RELEASE;TRANSDERMAL020076-005Nov 12, 1999► Subscribe► Subscribe
Sanofi Aventis Us
NICODERM CQ
nicotine
FILM, EXTENDED RELEASE;TRANSDERMAL020165-004Aug 2, 1996► Subscribe► Subscribe
Sanofi Aventis Us
NICODERM CQ
nicotine
FILM, EXTENDED RELEASE;TRANSDERMAL020165-005Aug 2, 1996► Subscribe► Subscribe
Dr Reddys Labs Sa
HABITROL
nicotine
FILM, EXTENDED RELEASE;TRANSDERMAL020076-006Nov 12, 1999► Subscribe► Subscribe
Pfizer Inc
NICOTROL
nicotine
SPRAY, METERED;NASAL020385-001Mar 22, 1996► Subscribe► Subscribe
Sanofi Aventis Us
NICODERM CQ
nicotine
FILM, EXTENDED RELEASE;TRANSDERMAL020165-006Aug 2, 1996► Subscribe► Subscribe
Aveva
PROSTEP
nicotine
FILM, EXTENDED RELEASE;TRANSDERMAL019983-003Dec 23, 1998► Subscribe► Subscribe
Sanofi Aventis Us
NICODERM CQ
nicotine
FILM, EXTENDED RELEASE;TRANSDERMAL020165-004Aug 2, 1996► Subscribe► Subscribe
Pharmacia And Upjohn
NICOTROL
nicotine
INHALANT;ORAL020714-001May 2, 1997► Subscribe► 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
South Africa200104966► Subscribe
Israel143778► Subscribe
Japan4864204► Subscribe
China101693023► Subscribe
Australia774594► Subscribe
Russian Federation2246937► Subscribe
Poland348337► Subscribe
Czech Republic302035► Subscribe
China1331586► Subscribe
Norway332084► 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:

Deloitte
Teva
AstraZeneca
Chinese Patent Office
Argus Health
US Army
Farmers Insurance
Healthtrust
Fuji
QuintilesIMS

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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