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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 six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has fifty-two patent family members in twenty-six countries.

There are twenty-eight drug master file entries for nicotine. Thirteen suppliers are listed for this compound.

Summary for Generic Name: nicotine

Drug Master File Entries: see list28
Suppliers: see list13
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
nicotine polacrilex
GUM, CHEWING;BUCCAL077656-001Jun 19, 2007OTCNo<disabled><disabled>
Watson Labs
nicotine polacrilex
GUM, CHEWING;BUCCAL079044-001Jul 8, 2009OTCNo<disabled><disabled>
FILM, EXTENDED RELEASE;TRANSDERMAL074612-002Jul 28, 2003OTCNo<disabled><disabled>
Sanofi Aventis Us
FILM, EXTENDED RELEASE;TRANSDERMAL020165-005Aug 2, 1996OTCYes8,663,680<disabled>Y<disabled>
Perrigo R And D
nicotine polacrilex
GUM, CHEWING;BUCCAL078967-001Apr 23, 2008OTCNo<disabled><disabled>
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International Patent Family for Ingredient: nicotine

Country Document Number Publication Date
European Patent Office2158903Mar 03, 2010
Denmark0619729Apr 17, 2000
Portugal1140039Feb 03, 2010
Germany69325643Aug 19, 1999
Japan2002532540Oct 02, 2002
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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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