You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: April 19, 2024

Details for New Drug Application (NDA): 022360

✉ Email this page to a colleague

« Back to Dashboard

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 are thirty drug master file entries 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
Formulation / Manufacturing:	see details

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:	⤷ Try a Trial	Patent Expiration:	Jun 14, 2029	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Try a 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:	⤷ Try a Trial	Patent Expiration:	Jun 14, 2029	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 022360

Subscribe to access the full database, or Try a Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

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.