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Last Updated: January 27, 2023

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, Aurobindo Pharma Ltd, Dr Reddys Labs Sa, and Pld Acquisitions, and is included in fifty-four 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 eleven drug master file entries for nicotine polacrilex. Fifty-four 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

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
Perrigo R And D NICOTINE POLACRILEX nicotine polacrilex GUM, CHEWING;BUCCAL 078325-001 Oct 30, 2006 OTC No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
P And L NICOTINE POLACRILEX nicotine polacrilex TROCHE/LOZENGE;ORAL 209520-001 Oct 31, 2019 OTC No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Dr Reddys Labs Sa NICOTINE POLACRILEX nicotine polacrilex TROCHE/LOZENGE;ORAL 212796-001 Jan 8, 2020 OTC No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Perrigo R And D NICOTINE POLACRILEX nicotine polacrilex GUM, CHEWING;BUCCAL 078546-001 May 24, 2007 OTC No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
P And L NICOTINE POLACRILEX nicotine polacrilex TROCHE/LOZENGE;ORAL 209206-001 Jun 26, 2018 OTC No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline NICORETTE nicotine polacrilex TROCHE/LOZENGE;ORAL 022360-001 May 18, 2009 See Plans and Pricing See Plans and Pricing
Glaxosmithkline Cons NICORETTE nicotine polacrilex TROCHE/LOZENGE;ORAL 021330-001 Oct 31, 2002 See Plans and Pricing See Plans and Pricing
Glaxosmithkline Cons NICORETTE nicotine polacrilex TROCHE/LOZENGE;ORAL 021330-002 Oct 31, 2002 See Plans and Pricing See Plans and Pricing
Glaxosmithkline NICORETTE nicotine polacrilex TROCHE/LOZENGE;ORAL 022360-002 May 18, 2009 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for nicotine polacrilex

Country Patent Number Title Estimated Expiration
South Africa 200710905 Flavoring of drug-containing chewing gums See Plans and Pricing
Japan 6159761 See Plans and Pricing
World Intellectual Property Organization (WIPO) 2009134947 See Plans and Pricing
World Intellectual Property Organization (WIPO) 2006124366 See Plans and Pricing
Japan 2015232012 ニコチンロゼンジ組成物 (NICOTINE LOZENGE COMPOSITION) See Plans and Pricing
>Country >Patent Number >Title >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.