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Last Updated: March 29, 2024

Nicotine - Generic Drug Details


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What are the generic drug 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, Chattem Sanofi, Aveva, Mcneil Cons, Pfizer, Pfizer Inc, Haleon Us Holdings, Fertin Pharma, Ivax Sub Teva Pharms, L Perrigo Co, P And L, Perrigo R And D, Glaxosmithkline Cons, Aurobindo Pharma, Aurobindo Pharma Ltd, and Pld Acquisitions, and is included in sixty-two NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are thirty drug master file entries for nicotine. Twenty-six 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
Alternative Research Initiative (Pvt.) LtdEarly Phase 1
Foundation for a Smoke-Free WorldEarly Phase 1
Het Zwarte GatPhase 2

See all nicotine clinical trials

Pharmacology for nicotine
Medical Subject Heading (MeSH) Categories for nicotine
Paragraph IV (Patent) Challenges for NICOTINE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
NICODERM CQ Transdermal System nicotine 7 mg/24 hrs 14 mg/24 hrs 21 mg/24 hrs 020165 1 2014-05-30

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
Pfizer Inc NICOTROL nicotine SPRAY, METERED;NASAL 020385-001 Mar 22, 1996 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
P And L NICOTINE POLACRILEX nicotine polacrilex GUM, CHEWING;BUCCAL 079044-001 Jul 8, 2009 OTC No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Haleon Us Holdings NICORETTE (MINT) nicotine polacrilex GUM, CHEWING;BUCCAL 018612-003 Dec 23, 1998 OTC Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Perrigo R And D NICOTINE POLACRILEX nicotine polacrilex TROCHE/LOZENGE;ORAL 077007-001 Jan 31, 2006 OTC No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
L Perrigo Co NICOTINE POLACRILEX nicotine polacrilex GUM, CHEWING;BUCCAL 076778-001 Sep 16, 2004 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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
Chattem Sanofi NICODERM CQ nicotine FILM, EXTENDED RELEASE;TRANSDERMAL 020165-006 Aug 2, 1996 ⤷  Try a Trial ⤷  Try a Trial
Chattem Sanofi NICODERM CQ nicotine FILM, EXTENDED RELEASE;TRANSDERMAL 020165-005 Aug 2, 1996 ⤷  Try a Trial ⤷  Try a Trial
Pfizer NICOTROL nicotine INHALANT;ORAL 020714-001 May 2, 1997 ⤷  Try a Trial ⤷  Try a Trial
Chattem Sanofi NICODERM CQ nicotine FILM, EXTENDED RELEASE;TRANSDERMAL 020165-004 Aug 2, 1996 ⤷  Try a Trial ⤷  Try a Trial
Chattem Sanofi NICODERM CQ nicotine FILM, EXTENDED RELEASE;TRANSDERMAL 020165-004 Aug 2, 1996 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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