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Last Updated: August 12, 2020

DrugPatentWatch Database Preview

NICOTINE - Generic Drug Details

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

Nicotine is the generic ingredient in nine branded drugs marketed by Dr Reddys Labs Sa, Sanofi Aventis Us, Aveva, Mcneil Cons, Pharmacia And Upjohn, Pfizer Inc, Glaxosmithkline, Ivax Sub Teva Pharms, L Perrigo Co, P And L, Perrigo R And D, Glaxosmithkline Cons, and Pld Acquisitions, and is included in fifty-eight NDAs. There are six 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 thirty drug master file entries for nicotine. Twenty-three suppliers are listed for this compound.

Drug Prices for NICOTINE

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Drug Sales Revenue Trends for NICOTINE

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Recent Clinical Trials for NICOTINE

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SponsorPhase
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Phase 2
Mayo ClinicEarly Phase 1
Ottawa Heart Institute Research CorporationN/A

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Pharmacology for NICOTINE
Medical Subject Heading (MeSH) Categories for NICOTINE
Paragraph IV (Patent) Challenges for NICOTINE
Tradename Dosage Ingredient NDA Submissiondate
NICODERM CQ FILM, EXTENDED RELEASE;TRANSDERMAL nicotine 020165 2014-05-30
HABITROL FILM, EXTENDED RELEASE;TRANSDERMAL nicotine 020076

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
Glaxosmithkline NICORETTE nicotine polacrilex GUM, CHEWING;BUCCAL 018612-004 Sep 25, 2000 OTC Yes No   Start Trial   Start Trial   Start Trial
P And L NICOTINE POLACRILEX nicotine polacrilex GUM, CHEWING;BUCCAL 079219-001 Jul 8, 2009 OTC No No   Start Trial   Start Trial   Start Trial
Aveva PROSTEP nicotine FILM, EXTENDED RELEASE;TRANSDERMAL 019983-003 Dec 23, 1998 DISCN No No   Start Trial   Start Trial   Start Trial
Perrigo R And D NICOTINE POLACRILEX nicotine polacrilex GUM, CHEWING;BUCCAL 078968-001 Apr 23, 2008 OTC No No   Start Trial   Start Trial   Start Trial
Glaxosmithkline Cons NICORETTE nicotine polacrilex TROCHE/LOZENGE;ORAL 022360-001 May 18, 2009 OTC Yes No   Start Trial   Start Trial Y   Start Trial
Sanofi Aventis Us NICODERM CQ nicotine FILM, EXTENDED RELEASE;TRANSDERMAL 020165-006 Aug 2, 1996 OTC Yes No   Start Trial   Start Trial Y   Start 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 NICOTINE

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

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Serving leading biopharmaceutical companies globally:

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