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Last Updated: March 19, 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, and Pld Acquisitions. 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

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

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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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Aurobindo Pharma NICOTINE POLACRILEX nicotine polacrilex TROCHE/LOZENGE;ORAL 213266-001 Aug 3, 2021 OTC No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
P And L NICOTINE POLACRILEX nicotine polacrilex TROCHE/LOZENGE;ORAL 212057-001 May 14, 2020 OTC No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Perrigo R And D NICOTINE POLACRILEX nicotine polacrilex TROCHE/LOZENGE;ORAL 090821-001 Jul 10, 2009 OTC No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
P And L NICOTINE POLACRILEX nicotine polacrilex TROCHE/LOZENGE;ORAL 209520-001 Oct 31, 2019 OTC No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
P And L NICOTINE POLACRILEX nicotine polacrilex TROCHE/LOZENGE;ORAL 208875-002 Oct 31, 2019 OTC No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
P And L NICOTINE POLACRILEX nicotine polacrilex TROCHE/LOZENGE;ORAL 210712-002 Sep 6, 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

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