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Last Updated: May 8, 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

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Sponsor	Phase
GlaxoSmithKline	Phase 1
Vince & Associates Clinical Research, Inc.	Phase 1
22nd Century Group, 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
Dr Reddys Labs Sa	NICOTINE POLACRILEX	nicotine polacrilex	TROCHE/LOZENGE;ORAL	212796-002	Jan 8, 2020		OTC	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
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
Aurobindo Pharma Ltd	NICOTINE POLACRILEX	nicotine polacrilex	TROCHE/LOZENGE;ORAL	215357-002	May 13, 2022		OTC	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Haleon Us Holdings	NICORETTE	nicotine polacrilex	GUM, CHEWING;BUCCAL	020066-004	Sep 25, 2000		OTC	Yes	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	021330-001	Oct 31, 2002	⤷ Try a Trial	⤷ Try a Trial
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	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
Portugal	2285411		⤷ Try a Trial
Japan	6159761		⤷ Try a Trial
Brazil	PI0611520	aromatização de gomas de mascar contendo drogas	⤷ Try a Trial
South Korea	20080037614	FLAVORING OF DRUG-CONTAINING CHEWING GUMS	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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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.