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Last Updated: March 28, 2024

Nicotine - Generic Drug Details


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What are the generic sources for nicotine and what is the scope of patent protection?

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

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
Alternative Research Initiative (Pvt.) LtdEarly Phase 1
Foundation for a Smoke-Free WorldEarly Phase 1
Radboud University Medical CenterPhase 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
Pld Acquisitions NICOTINE POLACRILEX nicotine polacrilex TROCHE/LOZENGE;ORAL 207868-002 Feb 7, 2019 OTC No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
P And L NICOTINE POLACRILEX nicotine polacrilex GUM, CHEWING;BUCCAL 074507-001 Mar 15, 1999 OTC No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
P And L NICOTINE POLACRILEX nicotine polacrilex TROCHE/LOZENGE;ORAL 210711-002 Oct 31, 2019 OTC 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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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