NICOTINE Drug Patent Profile

When do Nicotine patents expire, and what generic alternatives are available?

Nicotine is a drug marketed by Aveva, Fertin Pharma, Ivax Sub Teva Pharms, L Perrigo Co, P And L, Perrigo R And D, Aurobindo Pharma, Aurobindo Pharma Ltd, Dr Reddys Labs Sa, and Pld Acquisitions. and is included in fifty NDAs.

The generic ingredient in NICOTINE is nicotine polacrilex. There are thirty drug master file entries for this compound. Sixty suppliers are listed for this compound. Additional details are available on the nicotine polacrilex profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Nicotine

A generic version of NICOTINE was approved as nicotine polacrilex by P AND L on March 15^th, 1999.

Summary for NICOTINE

US Patents:	0
Applicants:	10
NDAs:	50
Finished Product Suppliers / Packagers:	14
Raw Ingredient (Bulk) Api Vendors:	105
Clinical Trials:	921
Patent Applications:	6,093
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information 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
The Netherlands Cancer Institute	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

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Dr Reddys Labs Sa	NICOTINE POLACRILEX	nicotine polacrilex	TROCHE/LOZENGE;ORAL	213233-001	Aug 4, 2020		OTC	No	No
Perrigo R And D	NICOTINE POLACRILEX	nicotine polacrilex	GUM, CHEWING;BUCCAL	078968-001	Apr 23, 2008		DISCN	No	No
P And L	NICOTINE POLACRILEX	nicotine polacrilex	TROCHE/LOZENGE;ORAL	210711-001	Oct 31, 2019		OTC	No	No
P And L	NICOTINE POLACRILEX	nicotine polacrilex	TROCHE/LOZENGE;ORAL	212057-002	May 14, 2020		OTC	No	No
P And L	NICOTINE POLACRILEX	nicotine polacrilex	TROCHE/LOZENGE;ORAL	208875-001	Oct 31, 2019		OTC	No	No
P And L	NICOTINE POLACRILEX	nicotine polacrilex	TROCHE/LOZENGE;ORAL	210712-001	Sep 6, 2019		OTC	No	No
P And L	NICOTINE POLACRILEX	nicotine polacrilex	TROCHE/LOZENGE;ORAL	209519-002	Jul 2, 2018		OTC	No	No