NICOTINE - Generic Drug Details

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What are the generic sources for nicotine and what is the scope of freedom to operate?

Nicotine is the generic ingredient in nine branded drugs marketed by Dr Reddys Labs Sa, Chattem Sanofi, Difgen Pharms, Mcneil Cons, Aveva, 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, Pld Acquisitions, and Ppi-dac, 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-nine suppliers are listed for this compound.

Summary for NICOTINE

US Patents:	3
Tradenames:	9
Applicants:	18
NDAs:	62
Drug Master File Entries:	30
Finished Product Suppliers / Packagers:	29
Raw Ingredient (Bulk) Api Vendors:	105
Clinical Trials:	941
Patent Applications:	7,367
Drug Prices:	Drug price trends for NICOTINE
What excipients (inactive ingredients) are in NICOTINE?	NICOTINE excipients list
DailyMed Link:	NICOTINE at DailyMed

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See drug sales revenues for NICOTINE

Recent Clinical Trials for NICOTINE

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

Sponsor	Phase
Anna Stanhewicz, PhD	Early Phase 1
Multidisciplinary Association for Psychedelic Studies	Early Phase 1
Spaulding Rehabilitation Hospital	Early Phase 1

See all NICOTINE clinical trials

Pharmacology for NICOTINE

Drug Class	Cholinergic Nicotinic Agonist

Medical Subject Heading (MeSH) Categories for NICOTINE

Ganglionic Stimulants
Nicotinic Agonists

Anatomical Therapeutic Chemical (ATC) Classes for NICOTINE

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

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
Mcneil Cons	NICOTROL	nicotine	FILM, EXTENDED RELEASE;TRANSDERMAL	020536-001	Jul 3, 1996		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
P And L	NICOTINE POLACRILEX	nicotine polacrilex	TROCHE/LOZENGE;ORAL	212056-001	Jul 26, 2019		OTC	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Perrigo R And D	NICOTINE POLACRILEX	nicotine polacrilex	GUM, CHEWING;BUCCAL	078547-001	May 24, 2007		OTC	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
Perrigo R And D	NICOTINE POLACRILEX	nicotine polacrilex	GUM, CHEWING;BUCCAL	078325-001	Oct 30, 2006		OTC	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Haleon Us Holdings	NICORETTE	nicotine polacrilex	TROCHE/LOZENGE;ORAL	021330-001	Oct 31, 2002		OTC	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Difgen Pharms	NICOTINE	nicotine	FILM, EXTENDED RELEASE;TRANSDERMAL	074612-001	Oct 20, 1997		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

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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	⤷ Sign Up	⤷ Sign Up
Chattem Sanofi	NICODERM CQ	nicotine	FILM, EXTENDED RELEASE;TRANSDERMAL	020165-004	Aug 2, 1996	⤷ Sign Up	⤷ Sign Up
Pfizer	NICOTROL	nicotine	INHALANT;ORAL	020714-001	May 2, 1997	⤷ Sign Up	⤷ Sign Up
Chattem Sanofi	NICODERM CQ	nicotine	FILM, EXTENDED RELEASE;TRANSDERMAL	020165-006	Aug 2, 1996	⤷ Sign Up	⤷ Sign Up
Chattem Sanofi	NICODERM CQ	nicotine	FILM, EXTENDED RELEASE;TRANSDERMAL	020165-006	Aug 2, 1996	⤷ Sign Up	⤷ Sign Up
Mcneil Cons	NICOTROL	nicotine	FILM, EXTENDED RELEASE;TRANSDERMAL	020536-001	Jul 3, 1996	⤷ Sign Up	⤷ Sign Up
Aveva	PROSTEP	nicotine	FILM, EXTENDED RELEASE;TRANSDERMAL	019983-004	Dec 23, 1998	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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