Make Better Decisions

  • Uncover prior art in expired and abandoned patents
  • Obtain formulation and manufacturing information
  • Drug patents in 130+ countries
➤ Start Trial

or, See Plans & Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Cipla
AstraZeneca
Accenture
Cerilliant
UBS
McKinsey
Moodys
Merck
Covington
Cantor Fitzgerald

Generated: January 16, 2018

DrugPatentWatch Database Preview

NICORETTE Drug Profile

« Back to Dashboard

Which patents cover Nicorette, and what generic alternatives are available?

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

This drug has forty patent family members in twenty countries.

The generic ingredient in NICORETTE is nicotine polacrilex. There are twenty-nine drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the nicotine polacrilex profile page.

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 Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Glaxosmithkline Cons NICORETTE nicotine polacrilex TROCHE/LOZENGE;ORAL 022360-002 May 18, 2009 OTC Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Glaxosmithkline NICORETTE nicotine polacrilex GUM, CHEWING;BUCCAL 020066-004 Sep 25, 2000 OTC Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Glaxosmithkline Cons NICORETTE nicotine polacrilex TROCHE/LOZENGE;ORAL 022360-002 May 18, 2009 OTC Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Glaxosmithkline NICORETTE nicotine polacrilex GUM, CHEWING;BUCCAL 018612-004 Sep 25, 2000 OTC Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Glaxosmithkline NICORETTE nicotine polacrilex GUM, CHEWING;BUCCAL 020066-002 Feb 9, 1996 OTC Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Glaxosmithkline Cons NICORETTE nicotine polacrilex TROCHE/LOZENGE;ORAL 022360-001 May 18, 2009 OTC Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Glaxosmithkline Cons NICORETTE nicotine polacrilex TROCHE/LOZENGE;ORAL 022360-001 May 18, 2009 OTC Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Glaxosmithkline NICORETTE (MINT) nicotine polacrilex GUM, CHEWING;BUCCAL 020066-003 Dec 23, 1998 OTC Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Glaxosmithkline NICORETTE (MINT) nicotine polacrilex GUM, CHEWING;BUCCAL 018612-003 Dec 23, 1998 OTC Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

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

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

Paragraph IV (Patent) Challenges for NICORETTE
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Gum 2 mg ➤ Subscribe 1/22/2013
➤ Subscribe Gum 4 mg ➤ Subscribe 1/22/2013

Non-Orange Book US Patents for NICORETTE

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,658,200 Flavoring of drug-containing chewing gums ➤ Subscribe
Patent No. Title Estimated Patent Expiration

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

International Patents for NICORETTE

For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Medtronic
AstraZeneca
Harvard Business School
Queensland Health
UBS
Daiichi Sankyo
Covington
Cipla

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 verifification 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.

botpot