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Last Updated: April 24, 2024

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 Haleon Us Holdings, Fertin Pharma, 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-five 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. Sixty suppliers are listed for this compound.

Summary for nicotine polacrilex

International Patents:	44
US Patents:	3
Tradenames:	4
Applicants:	11
NDAs:	55
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	60
Raw Ingredient (Bulk) Api Vendors:	105
Clinical Trials:	22
Patent Applications:	6,666
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for nicotine polacrilex
What excipients (inactive ingredients) are in nicotine polacrilex?	nicotine polacrilex excipients list
DailyMed Link:	nicotine polacrilex at DailyMed

See drug prices for nicotine polacrilex

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

Sponsor	Phase
GlaxoSmithKline	Phase 1
22nd Century Group, Inc.	Phase 1
Vince & Associates Clinical Research, Inc.	Phase 1

See all nicotine polacrilex clinical trials

Pharmacology for nicotine polacrilex

Drug Class	Cholinergic Nicotinic Agonist

Anatomical Therapeutic Chemical (ATC) Classes for nicotine polacrilex

N07BA	Drugs used in nicotine dependence
N07B	DRUGS USED IN ADDICTIVE DISORDERS
N07	OTHER NERVOUS SYSTEM DRUGS
N	Nervous system

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

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Glossary

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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	212983-001	Feb 21, 2020		OTC	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Perrigo R And D	NICOTINE POLACRILEX	nicotine polacrilex	GUM, CHEWING;BUCCAL	091349-001	Jul 20, 2011		OTC	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
P And L	NICOTINE POLACRILEX	nicotine polacrilex	GUM, CHEWING;BUCCAL	079219-001	Jul 8, 2009		OTC	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
L Perrigo Co	NICOTINE POLACRILEX	nicotine polacrilex	GUM, CHEWING;BUCCAL	076778-001	Sep 16, 2004		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Fertin Pharma	NICOTINE POLACRILEX	nicotine polacrilex	GUM, CHEWING;BUCCAL	214354-001	Dec 21, 2022		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Haleon Us Holdings	NICORETTE	nicotine polacrilex	TROCHE/LOZENGE;ORAL	022360-001	May 18, 2009		OTC	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ 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
>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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Haleon Us Holdings	NICORETTE	nicotine polacrilex	TROCHE/LOZENGE;ORAL	021330-002	Oct 31, 2002	⤷ Try a Trial	⤷ Try a Trial
Haleon Us Holdings	NICORETTE	nicotine polacrilex	TROCHE/LOZENGE;ORAL	021330-001	Oct 31, 2002	⤷ Try a Trial	⤷ Try a Trial
Haleon Us Holdings	NICORETTE	nicotine polacrilex	TROCHE/LOZENGE;ORAL	022360-002	May 18, 2009	⤷ Try a Trial	⤷ Try a Trial
Haleon Us Holdings	NICORETTE	nicotine polacrilex	TROCHE/LOZENGE;ORAL	022360-001	May 18, 2009	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for nicotine polacrilex

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Country	Patent Number	Title	Estimated Expiration
Malaysia	164646	NICOTINE LOZENGE COMPOSITIONS	⤷ Try a Trial
Brazil	PI0911847	composições de pastilhas de nicotina	⤷ Try a Trial
Spain	2516650		⤷ Try a Trial
China	101222915	Flavoring of drug-containing chewing gums	⤷ Try a Trial
Mexico	2010011929	COMPOSICIONES DE COMPRIMIDOS DE NICOTINA. (NICOTINE LOZENGE COMPOSITIONS.)	⤷ Try a Trial
Hong Kong	1114767	含藥物口香糖的調味 (FLAVORING OF DRUG-CONTAINING CHEWING GUMS)	⤷ Try a Trial
Russian Federation	2007146992	ПРИДАНИЕ ВКУСА ЖЕВАТЕЛЬНЫМ РЕЗИНКАМ, СОДЕРЖАЩИМ ЛЕКАРСТВЕННОЕ СРЕДСТВО	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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