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Last Updated: April 16, 2024

Nicotine - Generic Drug Details

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

Nicotine is the generic ingredient in nine branded drugs marketed by Dr Reddys Labs Sa, Chattem Sanofi, Aveva, Mcneil Cons, Pfizer, Pfizer Inc, 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, and Pld Acquisitions, and is included in sixty-two NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are thirty drug master file entries for nicotine. Twenty-six suppliers are listed for this compound.

Summary for nicotine

US Patents:	3
Tradenames:	9
Applicants:	16
NDAs:	62
Drug Master File Entries:	30
Finished Product Suppliers / Packagers:	26
Raw Ingredient (Bulk) Api Vendors:	105
Clinical Trials:	921
Patent Applications:	6,296
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for nicotine
What excipients (inactive ingredients) are in nicotine?	nicotine excipients list
DailyMed Link:	nicotine at DailyMed

See drug prices for nicotine

See drug sales revenues for nicotine

Recent Clinical Trials for nicotine

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Alternative Research Initiative (Pvt.) Ltd	Early Phase 1
Foundation for a Smoke-Free World	Early Phase 1
Radboud University Medical Center	Phase 2

See all nicotine clinical trials

Pharmacology for nicotine

Drug Class	Cholinergic Nicotinic Agonist

Medical Subject Heading (MeSH) Categories for nicotine

Ganglionic Stimulants
Nicotinic Agonists

Paragraph IV (Patent) Challenges for NICOTINE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NICODERM CQ	Transdermal System	nicotine	7 mg/24 hrs 14 mg/24 hrs 21 mg/24 hrs	020165	1	2014-05-30

US Patents and Regulatory Information for nicotine

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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
Aurobindo Pharma	NICOTINE POLACRILEX	nicotine polacrilex	TROCHE/LOZENGE;ORAL	213266-001	Aug 3, 2021		OTC	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ 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
Perrigo R And D	NICOTINE POLACRILEX	nicotine polacrilex	GUM, CHEWING;BUCCAL	091349-001	Jul 20, 2011		OTC	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Haleon Us Holdings	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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	NICOTROL	nicotine	INHALANT;ORAL	020714-001	May 2, 1997	⤷ Try a Trial	⤷ Try a Trial
Dr Reddys Labs Sa	HABITROL	nicotine	FILM, EXTENDED RELEASE;TRANSDERMAL	020076-004	Nov 12, 1999	⤷ Try a Trial	⤷ Try a Trial
Aveva	PROSTEP	nicotine	FILM, EXTENDED RELEASE;TRANSDERMAL	019983-003	Dec 23, 1998	⤷ Try a Trial	⤷ Try a Trial
Dr Reddys Labs Sa	HABITROL	nicotine	FILM, EXTENDED RELEASE;TRANSDERMAL	020076-005	Nov 12, 1999	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent 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.