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Last Updated: December 13, 2019

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. Twenty-six 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
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 020165
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 0135-0194 0135-0194-01 7 PATCH in 1 CARTON (0135-0194-01) > 24 h in 1 PATCH
NICODERM CQ nicotine FILM, EXTENDED RELEASE;TRANSDERMAL 020165 NDA GlaxoSmithKline Consumer Healthcare Holdings (US) LLC 0135-0194 0135-0194-02 14 PATCH in 1 CARTON (0135-0194-02) > 24 h in 1 PATCH
Paragraph IV (Patent) Challenges for 020165
Tradename Dosage Ingredient NDA Submissiondate
NICODERM CQ FILM, EXTENDED RELEASE;TRANSDERMAL nicotine 020165 2014-05-30

Profile for product number 004

Active Rx/OTC/Discontinued:OTCDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength21MG/24HR
Approval Date:Aug 2, 1996TE:RLD:Yes
Patent:  Start TrialPatent Expiration:May 22, 2021Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Feb 13, 2020Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Feb 13, 2020Product 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

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