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Last Updated: April 28, 2024

NICOTINE POLACRILEX - Generic Drug Details

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What are the generic sources for nicotine polacrilex and what is the scope of freedom to operate?

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

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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

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
Haleon Us Holdings	NICORETTE	nicotine polacrilex	GUM, CHEWING;BUCCAL	020066-002	Feb 9, 1996		OTC	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Haleon Us Holdings	NICORETTE (MINT)	nicotine polacrilex	GUM, CHEWING;BUCCAL	018612-003	Dec 23, 1998		OTC	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Dr Reddys Labs Sa	NICOTINE POLACRILEX	nicotine polacrilex	TROCHE/LOZENGE;ORAL	212796-001	Jan 8, 2020		OTC	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
L Perrigo Co	NICOTINE POLACRILEX	nicotine polacrilex	GUM, CHEWING;BUCCAL	076789-001	Sep 16, 2004		OTC	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Pld Acquisitions	NICOTINE POLACRILEX	nicotine polacrilex	TROCHE/LOZENGE;ORAL	207868-002	Feb 7, 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
Canada	2608531	AROMATISANT POUR CHEWING GUMS CONTENANT UN MEDICAMENT (FLAVORING OF DRUG-CONTAINING CHEWING GUMS)	⤷ Try a Trial
Mexico	2010011929	COMPOSICIONES DE COMPRIMIDOS DE NICOTINA. (NICOTINE LOZENGE COMPOSITIONS.)	⤷ Try a Trial
Hong Kong	1197195	含藥口香糖的調味劑 (FLAVORING OF DRUG-CONTAINING CHEWING GUMS)	⤷ Try a Trial
Japan	5893405		⤷ Try a Trial
Australia	2009243065	Nicotine lozenge compositions	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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