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Serving leading biopharmaceutical companies globally:

QuintilesIMS
Fish and Richardson
Daiichi Sankyo
Federal Trade Commission
US Department of Justice
McKinsey
Express Scripts
Baxter
Cerilliant
Fuji

Generated: February 22, 2018

DrugPatentWatch Database Preview

NICOTINE POLACRILEX - Generic Drug Details

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What are the generic drug sources for nicotine polacrilex and what is the scope of nicotine polacrilex freedom to operate?

Nicotine polacrilex
is the generic ingredient in five branded drugs marketed by Glaxosmithkline, Actavis Labs Ny Inc, Ivax Sub Teva Pharms, L Perrigo Co, Perrigo R And D, Watson Labs, Novartis, and Glaxosmithkline Cons, and is included in forty NDAs. There are three patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Nicotine polacrilex has forty patent family members in twenty countries.

There are twenty-nine drug master file entries for nicotine polacrilex. Forty-three suppliers are listed for this compound.

US Patents and Regulatory Information for NICOTINE POLACRILEX

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Perrigo R And D NICOTINE POLACRILEX nicotine polacrilex GUM, CHEWING;BUCCAL 078546-001 May 24, 2007 OTC No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Glaxosmithkline Cons NICORETTE nicotine polacrilex TROCHE/LOZENGE;ORAL 022360-001 May 18, 2009 OTC Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Glaxosmithkline NICORETTE nicotine polacrilex GUM, CHEWING;BUCCAL 020066-004 Sep 25, 2000 OTC Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Perrigo R And D NICOTINE POLACRILEX nicotine polacrilex GUM, CHEWING;BUCCAL 206393-001 Dec 15, 2016 OTC No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Perrigo R And D NICOTINE POLACRILEX nicotine polacrilex GUM, CHEWING;BUCCAL 078325-001 Oct 30, 2006 OTC No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Glaxosmithkline NICORETTE nicotine polacrilex GUM, CHEWING;BUCCAL 018612-002 Feb 9, 1996 OTC Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Perrigo R And D NICOTINE POLACRILEX nicotine polacrilex GUM, CHEWING;BUCCAL 091349-001 Jul 20, 2011 OTC No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Actavis Labs Ny Inc NICOTINE POLACRILEX nicotine polacrilex GUM, CHEWING;BUCCAL 079038-001 Jul 8, 2009 OTC No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Glaxosmithkline Cons NICORETTE nicotine polacrilex TROCHE/LOZENGE;ORAL 022360-001 May 18, 2009 OTC Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
L Perrigo Co NICOTINE POLACRILEX nicotine polacrilex GUM, CHEWING;BUCCAL 076777-001 Sep 16, 2004 OTC No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for NICOTINE POLACRILEX

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

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Non-Orange Book US Patents for NICOTINE POLACRILEX

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 ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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International Patents for NICOTINE POLACRILEX

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

Serving hundreds of leading biopharmaceutical companies globally:

AstraZeneca
Chubb
Baxter
McKinsey
QuintilesIMS
US Army
Julphar
Daiichi Sankyo
Queensland Health

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.

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