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Nicotine - Generic Drug Details

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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-five 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-three suppliers are listed for this compound.

Summary for Generic Name: nicotine

Tradenames:10
Patents:7
Applicants:14
NDAs:45
Drug Master File Entries: see list29
Suppliers / Packaging: see list33
Therapeutic Class:Antidotes, Deterrents, and Toxicologic Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: nicotine

Ingredient-typeNicotine
Drug ClassCholinergic Nicotinic Agonist

Clinical Trials for: nicotine

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aveva
NICOTINE
nicotine
FILM, EXTENDED RELEASE;TRANSDERMAL074612-003Oct 20, 1997OTCNo
Actavis Labs Ny Inc
NICOTINE POLACRILEX
nicotine polacrilex
GUM, CHEWING;BUCCAL079216-001Jul 8, 2009OTCNo
Sanofi Aventis Us
NICODERM CQ
nicotine
FILM, EXTENDED RELEASE;TRANSDERMAL020165-006Aug 2, 1996OTCNo9,205,059Dec 15, 2019Y
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Expired Orange Book Patents for Generic Ingredient: nicotine

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pharmacia And Upjohn
NICOTROL
nicotine
INHALANT;ORAL020714-001May 2, 19974,917,120<disabled>
Pharmacia And Upjohn
NICOTROL
nicotine
INHALANT;ORAL020714-001May 2, 19974,800,903<disabled>
Pharmacia And Upjohn
NICOTROL
nicotine
INHALANT;ORAL020714-001May 2, 19974,793,366<disabled>
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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<disabled in preview>
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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
Japan4864204<disabled in preview>
Australia3121700<disabled in preview>
Poland348337<disabled in preview>
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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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