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Last Updated: November 22, 2024

NICOTINE Drug Patent Profile


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When do Nicotine patents expire, and what generic alternatives are available?

Nicotine is a drug marketed by Difgen Pharms, Fertin Pharma, Ivax Sub Teva Pharms, L Perrigo Co, P And L, Perrigo R And D, Aurobindo Pharma, Aurobindo Pharma Ltd, Dr Reddys Labs Sa, Pld Acquisitions, and Ppi-dac. and is included in fifty NDAs.

The generic ingredient in NICOTINE is nicotine polacrilex. There are thirty drug master file entries for this compound. Sixty suppliers are listed for this compound. Additional details are available on the nicotine polacrilex profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Nicotine

A generic version of NICOTINE was approved as nicotine polacrilex by P AND L on March 15th, 1999.

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Summary for NICOTINE
Drug patent expirations by year for NICOTINE
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
Anna Stanhewicz, PhDEarly Phase 1
Spaulding Rehabilitation HospitalEarly Phase 1
Multidisciplinary Association for Psychedelic StudiesEarly Phase 1

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
Dr Reddys Labs Sa NICOTINE POLACRILEX nicotine polacrilex TROCHE/LOZENGE;ORAL 213233-001 Aug 4, 2020 OTC No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Perrigo R And D NICOTINE POLACRILEX nicotine polacrilex GUM, CHEWING;BUCCAL 078968-001 Apr 23, 2008 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
P And L NICOTINE POLACRILEX nicotine polacrilex TROCHE/LOZENGE;ORAL 210711-001 Oct 31, 2019 OTC No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
P And L NICOTINE POLACRILEX nicotine polacrilex TROCHE/LOZENGE;ORAL 212057-002 May 14, 2020 OTC No 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

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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.