NICORETTE Drug Patent Profile

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When do Nicorette patents expire, and when can generic versions of Nicorette launch?

Nicorette is a drug marketed by Haleon Us Holdings and is included in four NDAs. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has forty-four patent family members in twenty-two countries.

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.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Nicorette

A generic version of NICORETTE was approved as nicotine polacrilex by P AND L on March 15^th, 1999.

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Summary for NICORETTE

International Patents:	44
US Patents:	3
Applicants:	1
NDAs:	4
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	105
Clinical Trials:	42
Patent Applications:	5,159
Drug Prices:	Drug price information for NICORETTE
What excipients (inactive ingredients) are in NICORETTE?	NICORETTE excipients list
DailyMed Link:	NICORETTE at DailyMed

Drug patent expirations by year for NICORETTE

Recent Clinical Trials for NICORETTE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
NYU Langone Health	Phase 1
National Center for Complementary and Integrative Health (NCCIH)	Early Phase 1
Washington State University	Early Phase 1

See all NICORETTE clinical trials

Pharmacology for NICORETTE

Drug Class	Cholinergic Nicotinic Agonist

Paragraph IV (Patent) Challenges for NICORETTE

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 NICORETTE

NICORETTE is protected by three US patents.

Patents protecting NICORETTE

Flavoring of drug-containing chewing gums
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Nicotine lozenge compositions
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Nicotine lozenge composition
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

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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	018612-002	Feb 9, 1996		OTC	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Haleon Us Holdings	NICORETTE	nicotine polacrilex	TROCHE/LOZENGE;ORAL	022360-001	May 18, 2009		OTC	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Haleon Us Holdings	NICORETTE	nicotine polacrilex	GUM, CHEWING;BUCCAL	020066-004	Sep 25, 2000		OTC	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Haleon Us Holdings	NICORETTE (MINT)	nicotine polacrilex	GUM, CHEWING;BUCCAL	020066-003	Dec 23, 1998		OTC	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Haleon Us Holdings	NICORETTE	nicotine polacrilex	TROCHE/LOZENGE;ORAL	021330-002	Oct 31, 2002		OTC	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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 NICORETTE

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

International Patents for NICORETTE

See the table below for patents covering NICORETTE around the world.

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Country	Patent Number	Title	Estimated Expiration
Denmark	1888042		⤷ Sign Up
Australia	2009243065	Nicotine lozenge compositions	⤷ Sign Up
China	108578392	含药口香糖的调味剂 (Flavoring of drug-containing chewing gums)	⤷ Sign Up
Canada	2723011	COMPOSITIONS DE TABLETTE DE NICOTINE (NICOTINE LOZENGE COMPOSITIONS)	⤷ Sign Up
Portugal	2285411		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration