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Serving leading biopharmaceutical companies globally:

UBS
Fish and Richardson
Accenture
QuintilesIMS
McKinsey
Harvard Business School
Express Scripts
Daiichi Sankyo
Deloitte
Chinese Patent Office

Generated: January 23, 2018

DrugPatentWatch Database Preview

Nicotine - Generic Drug Details

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

Nicotine
is the generic ingredient in ten branded drugs marketed by Dr Reddys Labs Sa, Sanofi Aventis Us, Aveva, Mcneil Cons, Pharmacia And Upjohn, Pfizer Inc, 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-seven NDAs. There are seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Nicotine has thirty patent family members in twenty-three countries.

There are twenty-nine drug master file entries for nicotine. Thirty-three suppliers are listed for this compound.
Pharmacology for nicotine
Ingredient-typeNicotine
Drug ClassCholinergic Nicotinic Agonist
Medical Subject Heading (MeSH) Categories for nicotine

US Patents and Regulatory Information for nicotine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Actavis Labs Ny Inc NICOTINE POLACRILEX nicotine polacrilex GUM, CHEWING;BUCCAL 078699-001 Dec 29, 2008 OTC No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Perrigo R And D NICOTINE POLACRILEX nicotine polacrilex TROCHE/LOZENGE;ORAL 203690-001 Oct 9, 2012 OTC No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
L Perrigo Co NICOTINE POLACRILEX nicotine polacrilex GUM, CHEWING;BUCCAL 076777-001 Sep 16, 2004 OTC No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Glaxosmithkline Cons NICORETTE nicotine polacrilex TROCHE/LOZENGE;ORAL 022360-002 May 18, 2009 OTC Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Perrigo R And D NICOTINE POLACRILEX nicotine polacrilex TROCHE/LOZENGE;ORAL 090821-001 Jul 10, 2009 OTC No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Perrigo R And D NICOTINE POLACRILEX nicotine polacrilex TROCHE/LOZENGE;ORAL 203690-002 Oct 9, 2012 OTC No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Perrigo R And D NICOTINE POLACRILEX nicotine polacrilex TROCHE/LOZENGE;ORAL 090711-001 Jul 10, 2009 OTC No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Perrigo R And D NICOTINE POLACRILEX nicotine polacrilex TROCHE/LOZENGE;ORAL 077007-002 Jan 31, 2006 OTC No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Perrigo R And D NICOTINE POLACRILEX nicotine polacrilex GUM, CHEWING;BUCCAL 078967-001 Apr 23, 2008 OTC No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
L Perrigo Co NICOTINE POLACRILEX nicotine polacrilex GUM, CHEWING;BUCCAL 076776-001 Sep 16, 2004 OTC No 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

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Expired US Patents for nicotine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us NICODERM CQ nicotine FILM, EXTENDED RELEASE;TRANSDERMAL 020165-006 Aug 2, 1996 ➤ Subscribe ➤ Subscribe
Sanofi Aventis Us NICODERM CQ nicotine FILM, EXTENDED RELEASE;TRANSDERMAL 020165-006 Aug 2, 1996 ➤ Subscribe ➤ Subscribe
Sanofi Aventis Us NICODERM CQ nicotine FILM, EXTENDED RELEASE;TRANSDERMAL 020165-006 Aug 2, 1996 ➤ Subscribe ➤ Subscribe
Pharmacia And Upjohn NICOTROL nicotine INHALANT;ORAL 020714-001 May 2, 1997 ➤ Subscribe ➤ Subscribe
Dr Reddys Labs Sa HABITROL nicotine FILM, EXTENDED RELEASE;TRANSDERMAL 020076-004 Nov 12, 1999 ➤ Subscribe ➤ Subscribe
Sanofi Aventis Us NICODERM CQ nicotine FILM, EXTENDED RELEASE;TRANSDERMAL 020165-004 Aug 2, 1996 ➤ Subscribe ➤ Subscribe
Sanofi Aventis Us NICODERM CQ nicotine FILM, EXTENDED RELEASE;TRANSDERMAL 020165-004 Aug 2, 1996 ➤ Subscribe ➤ Subscribe
Sanofi Aventis Us NICODERM CQ nicotine FILM, EXTENDED RELEASE;TRANSDERMAL 020165-005 Aug 2, 1996 ➤ Subscribe ➤ Subscribe
Sanofi Aventis Us NICODERM CQ nicotine FILM, EXTENDED RELEASE;TRANSDERMAL 020165-004 Aug 2, 1996 ➤ Subscribe ➤ Subscribe
Sanofi Aventis Us NICODERM CQ nicotine FILM, EXTENDED RELEASE;TRANSDERMAL 020165-005 Aug 2, 1996 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for nicotine

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
7,622,136 Transparent transdermal nicotine delivery devices ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for nicotine

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Serving leading biopharmaceutical companies globally:

Cerilliant
Fish and Richardson
Argus Health
Medtronic
US Department of Justice
Harvard Business School
Teva
Chinese Patent Office
AstraZeneca

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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