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 Glaxosmithkline, 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:	97
Clinical Trials:	22
Patent Applications:	4,989
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
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
Glaxosmithkline Cons	NICORETTE	nicotine polacrilex	TROCHE/LOZENGE;ORAL	021330-002	Oct 31, 2002		OTC	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
L Perrigo Co	NICOTINE POLACRILEX	nicotine polacrilex	GUM, CHEWING;BUCCAL	076775-001	Sep 16, 2004		OTC	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
P And L	NICOTINE POLACRILEX	nicotine polacrilex	TROCHE/LOZENGE;ORAL	212056-001	Jul 26, 2019		OTC	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Glaxosmithkline	NICORETTE	nicotine polacrilex	TROCHE/LOZENGE;ORAL	022360-002	May 18, 2009		OTC	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ 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
Glaxosmithkline	NICORETTE	nicotine polacrilex	TROCHE/LOZENGE;ORAL	022360-001	May 18, 2009	⤷ Try a Trial	⤷ Try a Trial
Glaxosmithkline	NICORETTE	nicotine polacrilex	TROCHE/LOZENGE;ORAL	022360-002	May 18, 2009	⤷ Try a Trial	⤷ Try a Trial
Glaxosmithkline Cons	NICORETTE	nicotine polacrilex	TROCHE/LOZENGE;ORAL	021330-002	Oct 31, 2002	⤷ Try a Trial	⤷ Try a Trial
Glaxosmithkline Cons	NICORETTE	nicotine polacrilex	TROCHE/LOZENGE;ORAL	021330-001	Oct 31, 2002	⤷ 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
Hungary	E031175		⤷ Try a Trial
Denmark	1888042		⤷ Try a Trial
South Africa	200710905	Flavoring of drug-containing chewing gums	⤷ Try a Trial
Hong Kong	1153146	尼古丁錠劑組合物 (NICOTINE LOZENGE COMPOSITIONS)	⤷ 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.