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Last Updated: August 8, 2020

DrugPatentWatch Database Preview

NICORETTE Drug Profile

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When do Nicorette patents expire, and when can generic versions of Nicorette launch?

Nicorette is a drug marketed by Glaxosmithkline and Glaxosmithkline Cons and is included in four NDAs. There are three patents protecting this drug and two Paragraph IV challenges.

This drug has forty-four patent family members in twenty-two countries.

The generic ingredient in NICORETTE is nicotine polacrilex. There are thirty drug master file entries for this compound. Fifty suppliers are listed for this compound. Additional details are available on the nicotine polacrilex profile page.

US ANDA Litigation and Generic Entry Outlook for Nicorette

A generic version of NICORETTE was approved as nicotine polacrilex by P AND L on March 15th, 1999.

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Drug patent expirations by year for NICORETTE
Drug Prices for NICORETTE

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Recent Clinical Trials for NICORETTE

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SponsorPhase
University of Wisconsin, MadisonPhase 4
National Cancer Institute (NCI)Phase 4
GlaxoSmithKlinePhase 1

See all NICORETTE clinical trials

Paragraph IV (Patent) Challenges for NICORETTE
Tradename Dosage Ingredient NDA Submissiondate
NICORETTE TROCHE/LOZENGE;ORAL nicotine polacrilex 022360 2015-12-02

US Patents and Regulatory Information for NICORETTE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline NICORETTE nicotine polacrilex GUM, CHEWING;BUCCAL 018612-002 Feb 9, 1996 OTC Yes No   Start Trial   Start Trial   Start Trial
Glaxosmithkline Cons NICORETTE nicotine polacrilex TROCHE/LOZENGE;ORAL 022360-001 May 18, 2009 OTC Yes No   Start Trial   Start Trial Y   Start Trial
Glaxosmithkline NICORETTE nicotine polacrilex GUM, CHEWING;BUCCAL 020066-004 Sep 25, 2000 OTC Yes No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for NICORETTE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline Cons NICORETTE nicotine polacrilex TROCHE/LOZENGE;ORAL 021330-001 Oct 31, 2002   Start Trial   Start Trial
Glaxosmithkline Cons NICORETTE nicotine polacrilex TROCHE/LOZENGE;ORAL 022360-002 May 18, 2009   Start Trial   Start Trial
Glaxosmithkline Cons NICORETTE nicotine polacrilex TROCHE/LOZENGE;ORAL 021330-002 Oct 31, 2002   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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