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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-two 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 list32
Therapeutic Class:Antidotes, Deterrents, and Toxicologic Agents
Formulation / Manufacturing:see details

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
Novartis
THRIVE
nicotine polacrilex
GUM, CHEWING;BUCCAL077656-001Jun 19, 2007OTCNo<disabled><disabled>
Sanofi Aventis Us
NICODERM CQ
nicotine
FILM, EXTENDED RELEASE;TRANSDERMAL020165-005Aug 2, 1996OTCYes8,075,911<disabled>Y <disabled>
Perrigo R And D
NICOTINE POLACRILEX
nicotine polacrilex
GUM, CHEWING;BUCCAL078968-001Apr 23, 2008OTCNo<disabled><disabled>
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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, 19975,400,808<disabled>
Dr Reddys Labs Inc
HABITROL
nicotine
FILM, EXTENDED RELEASE;TRANSDERMAL020076-006Nov 12, 19995,834,011<disabled>
Pharmacia And Upjohn
NICOTROL
nicotine
INHALANT;ORAL020714-001May 2, 19975,167,242<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
Czech Republic302035<disabled in preview>
Poland195871<disabled in preview>
Hungary0104728<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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