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Details for Generic Name: nicotine

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Nicotine is the generic ingredient in ten branded drugs marketed by Dr Reddys Labs Inc, Sanofi Aventis Us, Aveva, Mcneil Cons, Pharmacia And Upjohn, Pfizer Inc, Glaxosmithkline, Actavis Labs Ny Inc, Ivax Sub Teva Pharms, Perrigo, Perrigo R And D, Watson Labs, Novartis, and Glaxosmithkline Cons, and is included in forty-three 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 fifty-three patent family members in twenty-seven countries.

There are twenty-seven drug master file entries for nicotine. Sixteen suppliers are listed for this compound.

Summary for Generic Name: nicotine

Drug Master File Entries: see list27
Suppliers / Packaging: see list90
Therapeutic Class:Antidotes, Deterrents, and Toxicologic Agents
Formulation / Manufacturing:see details

Pharmacology for Ingredient: nicotine

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
Actavis Labs Ny Inc
nicotine polacrilex
GUM, CHEWING;BUCCAL076569-002Jul 29, 2004DISCNNo<disabled><disabled>
FILM, EXTENDED RELEASE;TRANSDERMAL074612-002Jul 28, 2003OTCNo<disabled><disabled>
Sanofi Aventis Us
FILM, EXTENDED RELEASE;TRANSDERMAL020165-006Aug 2, 1996OTCYes8,999,379<disabled> <disabled>
Sanofi Aventis Us
FILM, EXTENDED RELEASE;TRANSDERMAL020165-004Aug 2, 1996OTCYes8,663,680<disabled>Y <disabled>
Perrigo R And D
nicotine polacrilex
GUM, CHEWING;BUCCAL091354-001Jul 20, 2011OTCNo<disabled><disabled>
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International Patent Family for Ingredient: nicotine

Country Document Number Publication Date
Denmark0619729Apr 17, 2000
Czech Republic294555Feb 16, 2005
Turkey200101783May 21, 2002
European Patent Office1140039Oct 10, 2001
HungaryT73247Jul 29, 1996
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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