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Last Updated: August 13, 2020

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NICOTINE POLACRILEX Drug Profile

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

Nicotine Polacrilex is a drug marketed by 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-five NDAs.

The generic ingredient in NICOTINE POLACRILEX is nicotine polacrilex. There are thirty drug master file entries for this compound. Fifty 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 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
22nd Century Group, Inc.Phase 1
Vince & Associates Clinical Research, Inc.Phase 1

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Paragraph IV (Patent) Challenges for NICOTINE POLACRILEX
Tradename Dosage Ingredient NDA Submissiondate
NICORETTE TROCHE/LOZENGE;ORAL nicotine polacrilex 022360 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
P And L NICOTINE POLACRILEX nicotine polacrilex TROCHE/LOZENGE;ORAL 212056-001 Jul 26, 2019 OTC No No   Start Trial   Start Trial   Start Trial
Dr Reddys Labs Sa NICOTINE POLACRILEX nicotine polacrilex TROCHE/LOZENGE;ORAL 212983-001 Feb 21, 2020 OTC No No   Start Trial   Start Trial   Start Trial
P And L NICOTINE POLACRILEX nicotine polacrilex TROCHE/LOZENGE;ORAL 212056-002 Jul 26, 2019 OTC No No   Start Trial   Start Trial   Start Trial
Pld Acquisitions NICOTINE POLACRILEX nicotine polacrilex TROCHE/LOZENGE;ORAL 207868-002 Feb 7, 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

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