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Last Updated: June 23, 2024

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, 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-eight 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

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SponsorPhase
Multidisciplinary Association for Psychedelic StudiesEarly Phase 1
Spaulding Rehabilitation HospitalEarly Phase 1
Foundation for a Smoke Free World INCN/A

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
Aveva NICOTINE nicotine FILM, EXTENDED RELEASE;TRANSDERMAL 074612-002 Jul 28, 2003 OTC No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Aveva PROSTEP nicotine FILM, EXTENDED RELEASE;TRANSDERMAL 019983-003 Dec 23, 1998 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
P And L NICOTINE POLACRILEX nicotine polacrilex TROCHE/LOZENGE;ORAL 210712-001 Sep 6, 2019 OTC No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
L Perrigo Co NICOTINE POLACRILEX nicotine polacrilex GUM, CHEWING;BUCCAL 076779-001 Sep 16, 2004 OTC No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Haleon Us Holdings NICORETTE (MINT) nicotine polacrilex GUM, CHEWING;BUCCAL 018612-003 Dec 23, 1998 OTC Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Haleon Us Holdings NICORETTE nicotine polacrilex GUM, CHEWING;BUCCAL 018612-004 Sep 25, 2000 OTC Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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
Dr Reddys Labs Sa HABITROL nicotine FILM, EXTENDED RELEASE;TRANSDERMAL 020076-005 Nov 12, 1999 ⤷  Sign Up ⤷  Sign Up
Mcneil Cons NICOTROL nicotine FILM, EXTENDED RELEASE;TRANSDERMAL 020536-001 Jul 3, 1996 ⤷  Sign Up ⤷  Sign Up
Pfizer NICOTROL nicotine INHALANT;ORAL 020714-001 May 2, 1997 ⤷  Sign Up ⤷  Sign Up
Pfizer Inc NICOTROL nicotine SPRAY, METERED;NASAL 020385-001 Mar 22, 1996 ⤷  Sign Up ⤷  Sign Up
Chattem Sanofi NICODERM CQ nicotine FILM, EXTENDED RELEASE;TRANSDERMAL 020165-005 Aug 2, 1996 ⤷  Sign Up ⤷  Sign Up
Chattem Sanofi NICODERM CQ nicotine FILM, EXTENDED RELEASE;TRANSDERMAL 020165-006 Aug 2, 1996 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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