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Last Updated: March 18, 2024

NICORETTE Drug Patent Profile


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

Nicorette is a drug marketed by Haleon Us Holdings and is included in four NDAs. There are three patents protecting this drug and one Paragraph IV challenge.

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. Sixty suppliers are listed for this compound. Additional details are available on the nicotine polacrilex profile page.

DrugPatentWatch® 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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Summary for NICORETTE
Drug patent expirations by year for NICORETTE
Drug Prices for NICORETTE

See drug prices for NICORETTE

Recent Clinical Trials for NICORETTE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
NYU Langone HealthPhase 1
Washington State UniversityEarly Phase 1
Office of Dietary Supplements (ODS)Early Phase 1

See all NICORETTE clinical trials

Pharmacology for NICORETTE
Paragraph IV (Patent) Challenges for NICORETTE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
NICORETTE Troche/Lozenge (Mini) nicotine polacrilex 2 mg and 4 mg 022360 1 2015-12-02

US Patents and Regulatory Information for NICORETTE

NICORETTE is protected by three US patents.

Patents protecting NICORETTE

Flavoring of drug-containing chewing gums
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Nicotine lozenge compositions
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Nicotine lozenge composition
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Haleon Us Holdings NICORETTE nicotine polacrilex GUM, CHEWING;BUCCAL 018612-002 Feb 9, 1996 OTC Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Haleon Us Holdings NICORETTE nicotine polacrilex TROCHE/LOZENGE;ORAL 022360-001 May 18, 2009 OTC Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Haleon Us Holdings NICORETTE nicotine polacrilex GUM, CHEWING;BUCCAL 020066-004 Sep 25, 2000 OTC Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Haleon Us Holdings NICORETTE (MINT) nicotine polacrilex GUM, CHEWING;BUCCAL 020066-003 Dec 23, 1998 OTC Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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
Haleon Us Holdings NICORETTE nicotine polacrilex TROCHE/LOZENGE;ORAL 021330-001 Oct 31, 2002 ⤷  Try a Trial ⤷  Try a Trial
Haleon Us Holdings NICORETTE nicotine polacrilex TROCHE/LOZENGE;ORAL 022360-002 May 18, 2009 ⤷  Try a Trial ⤷  Try a Trial
Haleon Us Holdings NICORETTE nicotine polacrilex TROCHE/LOZENGE;ORAL 021330-002 Oct 31, 2002 ⤷  Try a Trial ⤷  Try a Trial
Haleon Us Holdings NICORETTE nicotine polacrilex TROCHE/LOZENGE;ORAL 022360-001 May 18, 2009 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for NICORETTE

See the table below for patents covering NICORETTE around the world.

Country Patent Number Title Estimated Expiration
Spain 2605244 ⤷  Try a Trial
Japan 5627851 ⤷  Try a Trial
Russian Federation 2429827 ПРИДАНИЕ ВКУСА ЖЕВАТЕЛЬНЫМ РЕЗИНКАМ, СОДЕРЖАЩИМ ЛЕКАРСТВЕННОЕ СРЕДСТВО (MEDICATED CHEWING GUM FLAVOURING) ⤷  Try a Trial
European Patent Office 1888042 AROMATISANT POUR CHEWING GUMS CONTENANT UN MEDICAMENT (FLAVORING OF DRUG-CONTAINING CHEWING GUMS) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated 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 verification 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.