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Last Updated: July 23, 2021

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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, Pfizer, 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 four 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. Thirteen 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

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

SponsorPhase
National Cancer Institute, FranceN/A
Institut Cancerologie de l'OuestN/A
Lok Sin Tong Benevolent Society, KowloonN/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
P And L NICOTINE POLACRILEX nicotine polacrilex GUM, CHEWING;BUCCAL 204794-001 May 10, 2016 OTC No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Pfizer NICOTROL nicotine INHALANT;ORAL 020714-001 May 2, 1997 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Perrigo R And D NICOTINE POLACRILEX nicotine polacrilex TROCHE/LOZENGE;ORAL 203690-001 Oct 9, 2012 OTC No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Pld Acquisitions NICOTINE POLACRILEX nicotine polacrilex TROCHE/LOZENGE;ORAL 207868-002 Feb 7, 2019 OTC No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Perrigo R And D NICOTINE POLACRILEX nicotine polacrilex GUM, CHEWING;BUCCAL 078547-001 May 24, 2007 OTC No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
P And L NICOTINE POLACRILEX nicotine polacrilex GUM, CHEWING;BUCCAL 074507-001 Mar 15, 1999 OTC No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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
Pfizer NICOTROL nicotine INHALANT;ORAL 020714-001 May 2, 1997 ⤷  Try it Free ⤷  Try it Free
Aveva PROSTEP nicotine FILM, EXTENDED RELEASE;TRANSDERMAL 019983-003 Dec 23, 1998 ⤷  Try it Free ⤷  Try it Free
Sanofi Aventis Us NICODERM CQ nicotine FILM, EXTENDED RELEASE;TRANSDERMAL 020165-006 Aug 2, 1996 ⤷  Try it Free ⤷  Try it Free
Sanofi Aventis Us NICODERM CQ nicotine FILM, EXTENDED RELEASE;TRANSDERMAL 020165-004 Aug 2, 1996 ⤷  Try it Free ⤷  Try it Free
Sanofi Aventis Us NICODERM CQ nicotine FILM, EXTENDED RELEASE;TRANSDERMAL 020165-006 Aug 2, 1996 ⤷  Try it Free ⤷  Try it Free
Sanofi Aventis Us NICODERM CQ nicotine FILM, EXTENDED RELEASE;TRANSDERMAL 020165-004 Aug 2, 1996 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Colorcon
Medtronic
Dow
McKinsey
Merck

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