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Last Updated: January 26, 2022

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Nicotine polacrilex - Generic Drug Details

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What are the generic drug sources for nicotine polacrilex and what is the scope of patent protection?

Nicotine polacrilex is the generic ingredient in four branded drugs marketed by Glaxosmithkline, Ivax Sub Teva Pharms, L Perrigo Co, P And L, Perrigo R And D, Glaxosmithkline Cons, Aurobindo Pharma Ltd, Dr Reddys Labs Sa, and Pld Acquisitions, and is included in fifty-three NDAs. There are three patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Nicotine polacrilex has forty-four patent family members in twenty-two countries.

There are thirty drug master file entries for nicotine polacrilex. Forty-seven suppliers are listed for this compound.

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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Pharmacology for nicotine polacrilex
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
Glaxosmithkline Cons NICORETTE nicotine polacrilex TROCHE/LOZENGE;ORAL 021330-001 Oct 31, 2002 OTC Yes No ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial
P And L NICOTINE POLACRILEX nicotine polacrilex TROCHE/LOZENGE;ORAL 208875-002 Oct 31, 2019 OTC No No ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial
P And L NICOTINE POLACRILEX nicotine polacrilex GUM, CHEWING;BUCCAL 079044-001 Jul 8, 2009 OTC No No ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial
Perrigo R And D NICOTINE POLACRILEX nicotine polacrilex GUM, CHEWING;BUCCAL 078968-001 Apr 23, 2008 OTC No No ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial
Glaxosmithkline NICORETTE nicotine polacrilex TROCHE/LOZENGE;ORAL 022360-001 May 18, 2009 OTC Yes No ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial Y ⤷  Sign up for a Free Trial
Glaxosmithkline NICORETTE nicotine polacrilex TROCHE/LOZENGE;ORAL 022360-002 May 18, 2009 OTC Yes Yes ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial Y ⤷  Sign up for a Free Trial
Ivax Sub Teva Pharms NICOTINE POLACRILEX nicotine polacrilex GUM, CHEWING;BUCCAL 077850-001 Feb 18, 2009 DISCN No No ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for nicotine polacrilex

International Patents for nicotine polacrilex

Country Patent Number Estimated Expiration
Spain 2605244 ⤷  Sign up for a Free Trial
South Korea 20080037614 ⤷  Sign up for a Free Trial
Denmark 2285411 ⤷  Sign up for a Free Trial
China 103784423 ⤷  Sign up for a Free Trial
China 108578392 ⤷  Sign up for a Free Trial
China 101222915 ⤷  Sign up for a Free Trial
Brazil PI0911847 ⤷  Sign up for a Free Trial
>Country >Patent Number >Estimated 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.