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Last Updated: November 17, 2024

NICOTINE POLACRILEX Drug Patent Profile


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Which patents cover Nicotine Polacrilex, and what generic alternatives are available?

Nicotine Polacrilex is a drug marketed by 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 forty-nine NDAs.

The generic ingredient in NICOTINE POLACRILEX 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 Polacrilex

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

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Drug patent expirations by year for NICOTINE POLACRILEX
Drug Prices for NICOTINE POLACRILEX

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Drug Sales Revenue Trends for NICOTINE POLACRILEX

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Recent Clinical Trials for NICOTINE POLACRILEX

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

SponsorPhase
GlaxoSmithKlinePhase 1
22nd Century Group, Inc.Phase 1
Vince & Associates Clinical Research, Inc.Phase 1

See all NICOTINE POLACRILEX clinical trials

Pharmacology for NICOTINE POLACRILEX
Paragraph IV (Patent) Challenges for NICOTINE POLACRILEX
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
NICORETTE Troche/Lozenge (Mini) nicotine polacrilex 2 mg and 4 mg 022360 1 2015-12-02

US Patents and Regulatory Information for NICOTINE POLACRILEX

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 213233-002 Aug 4, 2020 OTC No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Aurobindo Pharma NICOTINE POLACRILEX nicotine polacrilex TROCHE/LOZENGE;ORAL 213266-001 Aug 3, 2021 OTC No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
P And L NICOTINE POLACRILEX nicotine polacrilex TROCHE/LOZENGE;ORAL 212057-001 May 14, 2020 OTC No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Perrigo R And D NICOTINE POLACRILEX nicotine polacrilex TROCHE/LOZENGE;ORAL 077007-002 Jan 31, 2006 OTC No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
P And L NICOTINE POLACRILEX nicotine polacrilex TROCHE/LOZENGE;ORAL 209520-001 Oct 31, 2019 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.