Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 13, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022360

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NDA 022360 describes NICORETTE, which is a drug marketed by Glaxosmithkline and Glaxosmithkline Cons and is included in four NDAs. It is available from four suppliers. There are three patents protecting this drug and two Paragraph IV challenges. Additional details are available on the NICORETTE profile page.

The generic ingredient in NICORETTE is nicotine polacrilex. There are thirty drug master file entries for this compound. Fifty-two suppliers are listed for this compound. Additional details are available on the nicotine polacrilex profile page.
Summary for 022360
Tradename:NICORETTE
Applicant:Glaxosmithkline Cons
Ingredient:nicotine polacrilex
Patents:2
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 022360
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NICORETTE nicotine polacrilex TROCHE/LOZENGE;ORAL 022360 NDA GlaxoSmithKline Consumer Healthcare Holdings (US) LLC 0135-0508 0135-0508-02 3 CONTAINER in 1 CARTON (0135-0508-02) > 27 LOZENGE in 1 CONTAINER
NICORETTE nicotine polacrilex TROCHE/LOZENGE;ORAL 022360 NDA GlaxoSmithKline Consumer Healthcare Holdings (US) LLC 0135-0508 0135-0508-03 5 CONTAINER in 1 CARTON (0135-0508-03) > 27 LOZENGE in 1 CONTAINER
Paragraph IV (Patent) Challenges for 022360
Tradename Dosage Ingredient NDA Submissiondate
NICORETTE TROCHE/LOZENGE;ORAL nicotine polacrilex 022360 2015-12-02

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TROCHE/LOZENGE;ORALStrengthEQ 2MG BASE
Approval Date:May 18, 2009TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Jun 14, 2029Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Apr 30, 2029Product Flag?YSubstance Flag?Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:OTCDosage:TROCHE/LOZENGE;ORALStrengthEQ 4MG BASE
Approval Date:May 18, 2009TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Jun 14, 2029Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 022360

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline Cons NICORETTE nicotine polacrilex TROCHE/LOZENGE;ORAL 022360-001 May 18, 2009   Start Trial   Start Trial
Glaxosmithkline Cons NICORETTE nicotine polacrilex TROCHE/LOZENGE;ORAL 022360-002 May 18, 2009   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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