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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-two patent family members in twenty-six countries.

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

Summary for Generic Name: nicotine

Tradenames:10
Patents:7
Applicants:14
NDAs:43
Drug Master File Entries: see list27
Suppliers / Packaging: see list87
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
Actavis Labs Ny Inc
NICOTINE POLACRILEX
nicotine polacrilex
GUM, CHEWING;BUCCAL076568-001Jul 29, 2004DISCNNo<disabled><disabled>
Aveva
NICOTINE
nicotine
FILM, EXTENDED RELEASE;TRANSDERMAL074612-002Jul 28, 2003OTCNo<disabled><disabled>
Perrigo R And D
NICOTINE POLACRILEX
nicotine polacrilex
TROCHE/LOZENGE;ORAL090711-002Jul 10, 2009OTCNo<disabled><disabled>
Glaxosmithkline
NICORETTE
nicotine polacrilex
GUM, CHEWING;BUCCAL018612-004Sep 25, 2000OTCNo<disabled><disabled>
Pfizer Inc
NICOTROL
nicotine
SPRAY, METERED;NASAL020385-001Mar 22, 1996RXYes5,656,255<disabled><disabled>
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International Patent Family for Ingredient: nicotine

Country Document Number Publication Date
Hong Kong1040915May 07, 2010
Greece3031075Dec 31, 1999
Turkey200101783May 21, 2002
Japan3830158Oct 04, 2006
Canada2354621Sep 29, 2009
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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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