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Last Updated: September 24, 2020

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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-nine 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

See drug prices for nicotine

Drug Sales Revenue Trends for nicotine

See drug sales revenues for nicotine

Recent Clinical Trials for nicotine

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Medical University of South CarolinaPhase 1/Phase 2
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Phase 2
Mayo ClinicEarly Phase 1

See all nicotine clinical trials

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 Cons NICORETTE nicotine polacrilex TROCHE/LOZENGE;ORAL 021330-002 Oct 31, 2002 OTC Yes Yes   Start Trial   Start Trial   Start Trial
P And L NICOTINE POLACRILEX nicotine polacrilex TROCHE/LOZENGE;ORAL 212057-001 May 14, 2020 OTC No No   Start Trial   Start Trial   Start Trial
P And L NICOTINE POLACRILEX nicotine polacrilex TROCHE/LOZENGE;ORAL 209206-001 Jun 26, 2018 OTC No No   Start Trial   Start Trial   Start Trial
Glaxosmithkline NICORETTE nicotine polacrilex GUM, CHEWING;BUCCAL 020066-004 Sep 25, 2000 OTC Yes No   Start Trial   Start Trial   Start Trial
Glaxosmithkline NICORETTE (MINT) nicotine polacrilex GUM, CHEWING;BUCCAL 018612-003 Dec 23, 1998 OTC Yes No   Start Trial   Start Trial   Start Trial
Glaxosmithkline Cons THRIVE nicotine polacrilex GUM, CHEWING;BUCCAL 077658-001 Jun 19, 2007 DISCN No No   Start Trial   Start Trial   Start Trial
Perrigo R And D NICOTINE POLACRILEX nicotine polacrilex GUM, CHEWING;BUCCAL 091354-001 Jul 20, 2011 OTC No No   Start Trial   Start Trial   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
Aveva PROSTEP nicotine FILM, EXTENDED RELEASE;TRANSDERMAL 019983-004 Dec 23, 1998   Start Trial   Start Trial
Aveva PROSTEP nicotine FILM, EXTENDED RELEASE;TRANSDERMAL 019983-003 Dec 23, 1998   Start Trial   Start Trial
Mcneil Cons NICOTROL nicotine FILM, EXTENDED RELEASE;TRANSDERMAL 020536-001 Jul 3, 1996   Start Trial   Start Trial
Mcneil Cons NICOTROL nicotine FILM, EXTENDED RELEASE;TRANSDERMAL 020536-001 Jul 3, 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 020165-005 Aug 2, 1996   Start Trial   Start Trial
Sanofi Aventis Us NICODERM CQ nicotine FILM, EXTENDED RELEASE;TRANSDERMAL 020165-004 Aug 2, 1996   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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