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Last Updated: February 2, 2023

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, Chattem Sanofi, Aveva, Mcneil Cons, Pfizer, Pfizer Inc, Glaxosmithkline, 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-one 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

See drug sales revenues for nicotine

Recent Clinical Trials for nicotine

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

SponsorPhase
Radboud University Medical CenterPhase 2
Columbia UniversityPhase 2
Parnassia Addiction Research CentrePhase 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
Perrigo R And D NICOTINE POLACRILEX nicotine polacrilex GUM, CHEWING;BUCCAL 078325-001 Oct 30, 2006 OTC No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
P And L NICOTINE POLACRILEX nicotine polacrilex GUM, CHEWING;BUCCAL 074707-001 Mar 19, 1999 OTC No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Ivax Sub Teva Pharms NICOTINE POLACRILEX nicotine polacrilex GUM, CHEWING;BUCCAL 077850-001 Feb 18, 2009 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
P And L NICOTINE POLACRILEX nicotine polacrilex TROCHE/LOZENGE;ORAL 210712-002 Sep 6, 2019 OTC No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Perrigo R And D NICOTINE POLACRILEX nicotine polacrilex TROCHE/LOZENGE;ORAL 090821-001 Jul 10, 2009 OTC No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Aveva PROSTEP nicotine FILM, EXTENDED RELEASE;TRANSDERMAL 019983-004 Dec 23, 1998 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Glaxosmithkline NICORETTE nicotine polacrilex GUM, CHEWING;BUCCAL 018612-004 Sep 25, 2000 OTC Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 020165-005 Aug 2, 1996 See Plans and Pricing See Plans and Pricing
Chattem Sanofi NICODERM CQ nicotine FILM, EXTENDED RELEASE;TRANSDERMAL 020165-006 Aug 2, 1996 See Plans and Pricing See Plans and Pricing
Dr Reddys Labs Sa HABITROL nicotine FILM, EXTENDED RELEASE;TRANSDERMAL 020076-005 Nov 12, 1999 See Plans and Pricing See Plans and Pricing
Chattem Sanofi NICODERM CQ nicotine FILM, EXTENDED RELEASE;TRANSDERMAL 020165-005 Aug 2, 1996 See Plans and Pricing See Plans and Pricing
Chattem Sanofi NICODERM CQ nicotine FILM, EXTENDED RELEASE;TRANSDERMAL 020165-006 Aug 2, 1996 See Plans and Pricing See Plans and Pricing
Pfizer NICOTROL nicotine INHALANT;ORAL 020714-001 May 2, 1997 See Plans and Pricing See Plans and Pricing
Dr Reddys Labs Sa HABITROL nicotine FILM, EXTENDED RELEASE;TRANSDERMAL 020076-004 Nov 12, 1999 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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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 verification 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.