➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Johnson and Johnson
Baxter
Merck
McKesson
Colorcon

Last Updated: September 25, 2020

DrugPatentWatch Database Preview

NICOTINE Drug Profile

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

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

Nicotine is a drug marketed by Aveva, Ivax Sub Teva Pharms, L Perrigo Co, P And L, Perrigo R And D, Dr Reddys Labs Sa, and Pld Acquisitions. and is included in forty-seven NDAs.

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

US ANDA 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.

  Start Trial

Drug patent expirations by year for NICOTINE
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
Medical University of South CarolinaPhase 1/Phase 2
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Phase 2
Mayo ClinicEarly Phase 1

See all NICOTINE clinical trials

Medical Subject Heading (MeSH) Categories for NICOTINE
Paragraph IV (Patent) Challenges for NICOTINE
Tradename Dosage Ingredient NDA Submissiondate
NICODERM CQ FILM, EXTENDED RELEASE;TRANSDERMAL nicotine 020165 2014-05-30
HABITROL FILM, EXTENDED RELEASE;TRANSDERMAL nicotine 020076

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
P And L NICOTINE POLACRILEX nicotine polacrilex TROCHE/LOZENGE;ORAL 209206-001 Jun 26, 2018 OTC No No   Start Trial   Start Trial   Start Trial
Perrigo R And D NICOTINE POLACRILEX nicotine polacrilex GUM, CHEWING;BUCCAL 091354-001 Jul 20, 2011 OTC No No   Start Trial   Start Trial   Start Trial
P And L NICOTINE POLACRILEX nicotine polacrilex TROCHE/LOZENGE;ORAL 209206-002 Jun 26, 2018 OTC No No   Start Trial   Start Trial   Start Trial
Perrigo R And D NICOTINE POLACRILEX nicotine polacrilex TROCHE/LOZENGE;ORAL 077007-002 Jan 31, 2006 OTC No No   Start Trial   Start Trial   Start Trial
P And L NICOTINE POLACRILEX nicotine polacrilex TROCHE/LOZENGE;ORAL 210712-001 Sep 6, 2019 OTC No No   Start Trial   Start Trial   Start Trial
P And L NICOTINE POLACRILEX nicotine polacrilex TROCHE/LOZENGE;ORAL 209519-002 Jul 2, 2018 OTC No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

McKinsey
Boehringer Ingelheim
Mallinckrodt
Merck
Express Scripts
Colorcon

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.