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Generated: May 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020165

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NDA 020165 describes NICODERM CQ, which is a drug marketed by Sanofi Aventis Us and is included in one NDA. It is available from four suppliers. There are four patents protecting this drug and one Paragraph IV challenge. Additional details are available on the NICODERM CQ profile page.

The generic ingredient in NICODERM CQ is nicotine. There are thirty drug master file entries for this compound. Thirty-three suppliers are listed for this compound. Additional details are available on the nicotine profile page.

Summary for 020165

Tradename:	NICODERM CQ
Applicant:	Sanofi Aventis Us
Ingredient:	nicotine
Patents:	4
Therapeutic Class:	Antidotes, Deterrents, and Toxicologic Agents
Formulation / Manufacturing:	see details

Medical Subject Heading (MeSH) Categories for 020165

Ganglionic Stimulants
Nicotinic Agonists

Suppliers and Packaging for NDA: 020165

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NICODERM CQ	nicotine	FILM, EXTENDED RELEASE;TRANSDERMAL	020165	NDA	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	0135-0145	N	0135-0145-02
NICODERM CQ	nicotine	FILM, EXTENDED RELEASE;TRANSDERMAL	020165	NDA	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	0135-0194	N	0135-0194-01

Profile for product number 004

Active Rx/OTC/Discontinued:	OTC	Dosage:	FILM, EXTENDED RELEASE;TRANSDERMAL			Strength	21MG/24HR
Approval Date:	Aug 2, 1996	TE:		RLD:	Yes
Patent:	➤ Sign Up	Patent Expiration:	May 22, 2021	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	➤ Sign Up	Patent Expiration:	Feb 13, 2020	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	➤ Sign Up	Patent Expiration:	Feb 13, 2020	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	A METHOD TO REDUCE WITHDRAWAL SYMPTOMS, INCLUDING NICOTINE CRAVING, ASSOCIATED WITH SMOKING CESSATION

Expired US Patents for NDA 020165

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi Aventis Us	NICODERM CQ	nicotine	FILM, EXTENDED RELEASE;TRANSDERMAL	020165-005	Aug 2, 1996	➤ Sign Up	➤ Sign Up
Sanofi Aventis Us	NICODERM CQ	nicotine	FILM, EXTENDED RELEASE;TRANSDERMAL	020165-006	Aug 2, 1996	➤ Sign Up	➤ Sign Up
Sanofi Aventis Us	NICODERM CQ	nicotine	FILM, EXTENDED RELEASE;TRANSDERMAL	020165-004	Aug 2, 1996	➤ Sign Up	➤ Sign Up
Sanofi Aventis Us	NICODERM CQ	nicotine	FILM, EXTENDED RELEASE;TRANSDERMAL	020165-006	Aug 2, 1996	➤ Sign Up	➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

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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.