NICOTINE POLACRILEX - Generic Drug Details

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

See drug prices for NICOTINE POLACRILEX

See drug sales revenues for NICOTINE POLACRILEX

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
L Perrigo Co	NICOTINE POLACRILEX	nicotine polacrilex	GUM, CHEWING;BUCCAL	076777-001	Sep 16, 2004		OTC	No	No
Perrigo R And D	NICOTINE POLACRILEX	nicotine polacrilex	GUM, CHEWING;BUCCAL	078326-001	Oct 30, 2006		OTC	No	No
Haleon Us Holdings	NICORETTE	nicotine polacrilex	TROCHE/LOZENGE;ORAL	022360-001	May 18, 2009		OTC	Yes	No			Y
P And L	NICOTINE POLACRILEX	nicotine polacrilex	TROCHE/LOZENGE;ORAL	210711-001	Oct 31, 2019		OTC	No	No
P And L	NICOTINE POLACRILEX	nicotine polacrilex	TROCHE/LOZENGE;ORAL	209519-001	Jul 2, 2018		OTC	No	No
P And L	NICOTINE POLACRILEX	nicotine polacrilex	GUM, CHEWING;BUCCAL	074707-001	Mar 19, 1999		OTC	No	No
Fertin Pharma	NICOTINE POLACRILEX	nicotine polacrilex	GUM, CHEWING;BUCCAL	214354-001	Dec 21, 2022		DISCN	No	No

Expired US Patents for NICOTINE POLACRILEX

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
Haleon Us Holdings	NICORETTE	nicotine polacrilex	TROCHE/LOZENGE;ORAL	021330-001	Oct 31, 2002
Haleon Us Holdings	NICORETTE	nicotine polacrilex	TROCHE/LOZENGE;ORAL	022360-002	May 18, 2009
Haleon Us Holdings	NICORETTE	nicotine polacrilex	TROCHE/LOZENGE;ORAL	022360-001	May 18, 2009

International Patents for NICOTINE POLACRILEX

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2429827	ПРИДАНИЕ ВКУСА ЖЕВАТЕЛЬНЫМ РЕЗИНКАМ, СОДЕРЖАЩИМ ЛЕКАРСТВЕННОЕ СРЕДСТВО (MEDICATED CHEWING GUM FLAVOURING)
China	101222915	Flavoring of drug-containing chewing gums
New Zealand	563424	Flavoring of drug-containing chewing gums
World Intellectual Property Organization (WIPO)	2006124366
Spain	2605244
World Intellectual Property Organization (WIPO)	2009134947
China	108578392	含药口香糖的调味剂 (Flavoring of drug-containing chewing gums)