Unlock all Features See Plans and Pricing

Serving leading biopharmaceutical companies globally:

AstraZeneca
McKesson
Merck
Express Scripts
Dow
Moodys

Last Updated: June 27, 2022

NICORETTE Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard

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 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. Fifty 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.

  Try it Free

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
Office of Dietary Supplements (ODS)Early Phase 1
National Center for Complementary and Integrative Health (NCCIH)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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Nicotine lozenge compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Nicotine lozenge composition
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Glaxosmithkline NICORETTE nicotine polacrilex TROCHE/LOZENGE;ORAL 022360-002 May 18, 2009 OTC Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Glaxosmithkline NICORETTE nicotine polacrilex GUM, CHEWING;BUCCAL 020066-004 Sep 25, 2000 OTC Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 021330-002 Oct 31, 2002 See Plans and Pricing See Plans and Pricing
Glaxosmithkline NICORETTE nicotine polacrilex TROCHE/LOZENGE;ORAL 022360-001 May 18, 2009 See Plans and Pricing See Plans and Pricing
Glaxosmithkline NICORETTE nicotine polacrilex TROCHE/LOZENGE;ORAL 022360-002 May 18, 2009 See Plans and Pricing See Plans and Pricing
>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
Australia 2006247847 Flavoring of drug-containing chewing gums See Plans and Pricing
World Intellectual Property Organization (WIPO) 9203124 See Plans and Pricing
Russian Federation 2458692 НИКОТИНСОДЕРЖАЩИЕ КОМПОЗИЦИИ ДЛЯ РАССАСЫВАНИЯ (ORALLY DISINTEGRATING NICOTINE-CONTAINING COMPOSITIONS) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Dow
McKinsey
Baxter
Johnson and Johnson
McKesson
Medtronic

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.