You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: May 20, 2024

Nicotine polacrilex - Generic Drug Details

✉ Email this page to a colleague

« Back to Dashboard

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, 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

Drug Sales Revenue Trends 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
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

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

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or 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
Pld Acquisitions	NICOTINE POLACRILEX	nicotine polacrilex	TROCHE/LOZENGE;ORAL	207868-001	Feb 7, 2019		OTC	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Perrigo R And D	NICOTINE POLACRILEX	nicotine polacrilex	GUM, CHEWING;BUCCAL	078967-001	Apr 23, 2008		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
P And L	NICOTINE POLACRILEX	nicotine polacrilex	GUM, CHEWING;BUCCAL	204833-001	Feb 26, 2016		OTC	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
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
P And L	NICOTINE POLACRILEX	nicotine polacrilex	TROCHE/LOZENGE;ORAL	212056-002	Jul 26, 2019		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
Haleon Us Holdings	NICORETTE	nicotine polacrilex	TROCHE/LOZENGE;ORAL	022360-001	May 18, 2009		OTC	Yes	No	⤷ 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

Subscribe to access the full database, or Try a Trial
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	022360-002	May 18, 2009	⤷ 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	022360-001	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

Subscribe to access the full database, or Try a Trial
Country	Patent Number	Title	Estimated Expiration
South Africa	200710905	Flavoring of drug-containing chewing gums	⤷ Try a Trial
Portugal	2285411		⤷ Try a Trial
Hong Kong	1114767	含藥物口香糖的調味 (FLAVORING OF DRUG-CONTAINING CHEWING GUMS)	⤷ Try a Trial
Poland	1888042		⤷ Try a Trial
Chile	2009001025	Composicion de pastilla para chupar que comprende: a) un granulo patron con al menos: un agente tampon alcalino, un modificador de la disolucion y una carga, b) un principio activo de nicotina definido extragranular y al menos un agente tampon alcalino; procedimiento de preparacion; util para eliminar o reducir el uso de tabaco.	⤷ Try a Trial
Denmark	2285411		⤷ Try a Trial
Poland	2285411		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Make Better Decisions: Try a trial or see plans & pricing

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.