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Generated: December 17, 2017

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 twenty-nine 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:1
Applicant:1
Ingredient:1
Patents:4
Therapeutic Class:Antidotes, Deterrents, and Toxicologic Agents
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 0135-0145 0135-0145-02 14 PATCH in 1 CARTON (0135-0145-02) > 24 h in 1 PATCH
NICODERM CQ nicotine FILM, EXTENDED RELEASE;TRANSDERMAL 020165 NDA GlaxoSmithKline Consumer Healthcare Holdings (US) LLC 0135-0194 0135-0194-05 14 PATCH in 1 CARTON (0135-0194-05) > 24 h in 1 PATCH (0135-0194-08)

Summary for product number 004

Active Rx/OTC/Discontinued:OTCDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength21MG/24HR
Approval Date:Aug 2, 1996TE:RLD:Yes
Patent:► SubscribePatent Expiration:May 22, 2021Product Flag?YSubstance Flag?Delist Request?
Patent:► SubscribePatent Expiration:Feb 13, 2020Product Flag?YSubstance Flag?Delist Request?
Patent:► SubscribePatent 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 Orange Book Patents for NDA: 020165

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis UsNICODERM CQnicotineFILM, EXTENDED RELEASE;TRANSDERMAL020165-006Aug 2, 1996► Subscribe► Subscribe
Sanofi Aventis UsNICODERM CQnicotineFILM, EXTENDED RELEASE;TRANSDERMAL020165-005Aug 2, 1996► Subscribe► Subscribe
Sanofi Aventis UsNICODERM CQnicotineFILM, EXTENDED RELEASE;TRANSDERMAL020165-005Aug 2, 1996► Subscribe► Subscribe
Sanofi Aventis UsNICODERM CQnicotineFILM, EXTENDED RELEASE;TRANSDERMAL020165-005Aug 2, 1996► Subscribe► Subscribe
Sanofi Aventis UsNICODERM CQnicotineFILM, EXTENDED RELEASE;TRANSDERMAL020165-005Aug 2, 1996► Subscribe► Subscribe
Sanofi Aventis UsNICODERM CQnicotineFILM, EXTENDED RELEASE;TRANSDERMAL020165-004Aug 2, 1996► Subscribe► Subscribe
Sanofi Aventis UsNICODERM CQnicotineFILM, EXTENDED RELEASE;TRANSDERMAL020165-006Aug 2, 1996► Subscribe► Subscribe
Sanofi Aventis UsNICODERM CQnicotineFILM, EXTENDED RELEASE;TRANSDERMAL020165-005Aug 2, 1996► Subscribe► Subscribe
Sanofi Aventis UsNICODERM CQnicotineFILM, EXTENDED RELEASE;TRANSDERMAL020165-004Aug 2, 1996► Subscribe► Subscribe
Sanofi Aventis UsNICODERM CQnicotineFILM, EXTENDED RELEASE;TRANSDERMAL020165-004Aug 2, 1996► Subscribe► Subscribe
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