Last Updated: September 24, 2026

Details for New Drug Application (NDA): 022360

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NDA 022360 describes NICORETTE, which is a drug marketed by Haleon Us Holdings and is included in four NDAs. It is available from two suppliers. There are three patents protecting this drug and two Paragraph IV challenges. Additional details are available on the NICORETTE profile page.

The generic ingredient in NICORETTE is nicotine polacrilex. There is one drug master file entry for this compound. Sixty suppliers are listed for this compound. Additional details are available on the nicotine polacrilex profile page.

Summary for 022360

Tradename:	NICORETTE
Applicant:	Haleon Us Holdings
Ingredient:	nicotine polacrilex
Patents:	2

Pharmacology for NDA: 022360

Suppliers and Packaging for NDA: 022360

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NICORETTE	nicotine polacrilex	TROCHE/LOZENGE;ORAL	022360	NDA	Haleon US Holdings LLC	0135-0508	0135-0508-02	3 CONTAINER in 1 CARTON (0135-0508-02) / 27 LOZENGE in 1 CONTAINER
NICORETTE	nicotine polacrilex	TROCHE/LOZENGE;ORAL	022360	NDA	Haleon US Holdings LLC	0135-0508	0135-0508-03	5 CONTAINER in 1 CARTON (0135-0508-03) / 27 LOZENGE in 1 CONTAINER

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	TROCHE/LOZENGE;ORAL			Strength	EQ 2MG BASE
Approval Date:	May 18, 2009	TE:		RLD:	Yes
Patent:	⤷ Start Trial	Patent Expiration:	Jun 14, 2029	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Start Trial	Patent Expiration:	Apr 30, 2029	Product Flag?	Y	Substance Flag?		Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:	OTC	Dosage:	TROCHE/LOZENGE;ORAL			Strength	EQ 4MG BASE
Approval Date:	May 18, 2009	TE:		RLD:	Yes
Patent:	⤷ Start Trial	Patent Expiration:	Jun 14, 2029	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 022360

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

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