Nicotine polacrilex - Generic Drug Details

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What are the generic drug sources for nicotine polacrilex and what is the scope of patent protection?

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, Pld Acquisitions, and Ppi-dac, 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:	12
NDAs:	55
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	60
Raw Ingredient (Bulk) Api Vendors:	105
Clinical Trials:	22
Patent Applications:	5,928
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

Drug Sales Revenue Trends for nicotine polacrilex

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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

Anatomical Therapeutic Chemical (ATC) Classes for nicotine polacrilex

N07BA	Drugs used in nicotine dependence
N07B	DRUGS USED IN ADDICTIVE DISORDERS
N07	OTHER NERVOUS SYSTEM DRUGS
N	Nervous system

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
P And L	NICOTINE POLACRILEX	nicotine polacrilex	TROCHE/LOZENGE;ORAL	212056-002	Jul 26, 2019		OTC	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Perrigo R And D	NICOTINE POLACRILEX	nicotine polacrilex	GUM, CHEWING;BUCCAL	078326-001	Oct 30, 2006		OTC	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
P And L	NICOTINE POLACRILEX	nicotine polacrilex	TROCHE/LOZENGE;ORAL	209206-001	Jun 26, 2018		OTC	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
L Perrigo Co	NICOTINE POLACRILEX	nicotine polacrilex	GUM, CHEWING;BUCCAL	076778-001	Sep 16, 2004		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Pld Acquisitions	NICOTINE POLACRILEX	nicotine polacrilex	TROCHE/LOZENGE;ORAL	207868-001	Feb 7, 2019		OTC	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
P And L	NICOTINE POLACRILEX	nicotine polacrilex	TROCHE/LOZENGE;ORAL	212057-001	May 14, 2020		OTC	No	No	⤷ 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 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	⤷ 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 nicotine polacrilex

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Country	Patent Number	Title	Estimated Expiration
Spain	2516650		⤷ Sign Up
Taiwan	200719915	Flavoring of drug-containing chewing gums	⤷ Sign Up
European Patent Office	2285411	COMPOSITIONS DE TABLETTE DE NICOTINE (NICOTINE LOZENGE COMPOSITIONS)	⤷ Sign Up
Hong Kong	1197195	含藥口香糖的調味劑 (FLAVORING OF DRUG-CONTAINING CHEWING GUMS)	⤷ Sign Up
Japan	5893405		⤷ Sign Up
Japan	2008540649		⤷ Sign Up
>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.