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Generated: April 22, 2018

DrugPatentWatch Database Preview

Nicotine - Generic Drug Details

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

Nicotine
is the generic ingredient in nine branded drugs marketed by Dr Reddys Labs Sa, Sanofi Aventis Us, Aveva, Mcneil Cons, Pharmacia And Upjohn, Pfizer Inc, Glaxosmithkline, Actavis Labs Ny Inc, Ivax Sub Teva Pharms, L Perrigo Co, Perrigo R And D, Watson Labs, and Glaxosmithkline Cons, and is included in forty-seven NDAs. There are seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Nicotine has thirty patent family members in twenty-three countries.

There are thirty drug master file entries for nicotine. Twenty-eight suppliers are listed for this compound.
Pharmacology for nicotine
Ingredient-typeNicotine
Drug ClassCholinergic Nicotinic Agonist
Medical Subject Heading (MeSH) Categories for nicotine
Synonyms for nicotine
(-)-.beta.-Pyridyl-.alpha.-N-methylpyrrolidine
(-)-1-(1/4)x>>u-2-(3-ssAa currency>>u)ssA inverted question mark(c)Ie
(-)-1-Methyl-2-(3-pyridyl)pyrrolidine, 3 Pyrid-N-methylpyrrolidin
(-)-3-(1-Methyl-2-pyrrolidyl)pyridine
(-)-3-(N-Methylpyrrolidino)pyridine
(-)-Nicotine
(-)-Nicotine solution
(-)-Nicotine solution, 1.0 mg/mL, analytical standard, for drug analysis
(-)-Nicotine solution, 100 mug/mL in acetonitrile, PESTANAL(R), analytical standard
(-)-Nicotine, >=99% (GC), liquid
(-)-Nicotine, PESTANAL(R), analytical standard
(-)-Nicotine;(S)-Nicotine
(2S) 3-(1-Methyl-pyrrolidin-2-yl)-pyridine
(S)-(-)--nicotine
(S)-(-)-Nicotine
(S)-(-)-NICOTINE, 3-[(2S)-1-METHYL-2-PYRROLIDINYL] PYRIDINE
(S)-(-)-Nicotine, 99% 25g
(S)-3-(1-Methyl-2-pyrrolidinyl)pyridine
(S)-3-(1-methylpyrrolidin-2-yl)pyridine
(S)-3-(N-methylpyrrolidin-2-yl)pyridine
(S)-Nicotine
006N369
1-methyl-2-(3-pyridal)-pyrrolidene
1-methyl-2-(3-pyridal)-Pyrrolidine
1-Methyl-2-(3-pyridiyl)pyrrolidine
1-Methyl-2-(3-pyridyl)pyrrolidine
13890-81-8
13890-82-9
16760-37-5
1uw6
3-((2S)-1-methylpyrrolidin-2-yl)pyridine
3-(1-Methyl-2-pyrollidinyl)pyridine
3-(1-methyl-2-pyrrolidinyl)-Pyridine
3-(1-Methyl-2-pyrrolidinyl)pyridine
3-(2-(N-methylpyrrolidinyl))pyridine
3-(N-Methylpyrollidino)pyridine
3-(N-Methylpyrrolidino)pyridine
3-[(1R)-1beta-Methylpyrrolidine-2alpha-yl]pyridine
3-[(2S)-1-methylpyrrolidin-2-yl]pyridine
3-N-methylpyrrolidine
434F7990-3240-4A43-ACEC-E6CC1E495FA0
54-11-5
551-13-3
6912-85-2
6M3C89ZY6R
a -N-methylpyrrolidine
a-N-methylpyrrolidine
AB00694322_12
AC1L3I79
AC1Q3ZOC
AI3-03424
AJ-21117
AK114679
alpha-N-methylpyrrolidine
AN-24414
BB_NC-0777
BDBM82070
beta-Pyridyl-alpha-N-methyl pyrrolidine
beta-Pyridyl-alpha-N-methylpyrrolidine
BIDD:GT0599
Black leaf
bmse000105
BRD-K05395900-322-02-1
C00745
Campbell's nico-soap
CAS_29790-52-1
CAS-54-11-5
Caswell No. 597
CCG-204892
CCRIS 1637
CHEBI:17688
CHEMBL3
CPD000059074
CS-3999
CTK8F2098
D03365
D05QIM
D0T8GD
DB00184
delta-Nicotine
destruxol
Destruxol orchid spray
DL-tetrahydronicotyrine
DSSTox_CID_930
DSSTox_GSID_20930
DSSTox_RID_75874
DTXSID1020930
EC 200-193-3
EINECS 200-193-3
Emo-nik
ENT 3,424
EPA Pesticide Chemical Code 056702
Exodus
Flux MAAG
FT-0603228
FT-0672702
fumeto bac
Fumetobac
GTPL2585
Habitrol
Habitrol (TN)
HE001276
HE350412
HMS2230H17
HMS3259E16
HSDB 1107
HY-B0638
I14-111388
J-500021
L-3-(1-Methyl-2-pyrrolidyl)pyridine
L-Nicotine
L(-)-nicotine
Mach-Nic
MCULE-8728421654
methyl-2-pyrrolidinyl)pyridine
MFCD00006369
Micotine
MLS001055457
MLS001335905
MolPort-000-744-731
N0079
NC00577
NCGC00090693-01
NCGC00090693-02
NCGC00090693-03
NCGC00090693-04
NCGC00090693-05
NCGC00090693-06
NCGC00090693-07
NCGC00090693-08
NCGC00090693-09
NCGC00254095-01
NCGC00259363-01
NCT
Niagara P.A. dust
Nic-Sal
Nicabate
Nico-dust
Nico-Fume
Nicocide
Nicoderm
Nicoderm Cq
Nicoderm Patch
Nicorette
Nicorette (TN)
Nicorette, Nicotrol
Nicotin
Nicotina
Nicotina [Italian]
Nicotine (compounds related to)
Nicotine (USP)
Nicotine [BSI:ISO]
Nicotine [for single use]
Nicotine [UN1654]
Nicotine [UN1654] [Poison]
Nicotine [UN1654] [Poison]
Nicotine [USAN]
Nicotine [USP:BAN]
Nicotine 10 microg/mL in Methanol
Nicotine 100 microg/mL in Methanol
Nicotine abuse therapy, ImmuLogic
Nicotine alkaloid
NICOTINE AND SALTS
Nicotine betadex
nicotine bitartrate anhydrous
Nicotine Difartrate
Nicotine Patch
Nicotine polacrilex
Nicotine polacrilex [USAN]
nicotine replacement patch
Nicotine solution
Nicotine vaccine, Xenova
Nicotine-D salicylate
NICOTINE-L (BASE)
Nicotinum
Nicotrol
Nicotrol Inhaler
Nicotrol NS
Nictoine patch
Nikotin [German]
Nikotyna
Nikotyna [Polish]
Niquitin
NSC 5065
Ortho N-4 and N-5 dusts
Ortho N-4 dust
Ortho N-5 dust
PDSP1_000113
PDSP1_000465
PDSP2_000463
PDSP2_000555
Prostep
Pyridine, 3-((2S)-1-methyl-2-pyrrolidinyl)-
Pyridine, 3-(1-methyl-2-pyrrolidinyl)-, (S)-
Pyridine, 3-(1-methyl-2-pyrrolidinyl)-, (S)- (9CI)
Pyridine, 3-(tetrahydro-1-methylpyrrol-2-yl)
Pyridine, 3-(tetrahydro-1-methylpyrrol-2-yl), (S)-
Pyrrolidine, 1-methyl-2-(3-pyridal)-
Pyrrolidine, 1-methyl-2-(3-pyridyl)-
R)-(+)-nicotine
RCRA waste no. P075
RCRA waste number P075
S-(-)-Nicotine
S-()-Nicotine-pyridine-d4
S(-)-Nicotine solution, 1.0 mg/mL in methanol, ampule of 1 mL, certified reference material
SAM002564224
SBB012359
SBI-0050785.P003
SC-58411
SCHEMBL20192
SDCCGMLS-0066911.P001
SMR000059074
SNICXCGAKADSCV-JTQLQIEISA-N
SR-05000001762
SR-05000001762-5
ST069320
TA-NIC
Tabazur
Tendust
Tetrahydronicotyrine, DL-
Tox21_201814
Tox21_300174
Transdermal Nicotine
UN1654
UNII-6M3C89ZY6R
Vaccine (nicotine), Xenova
XL All Insecticide
Z1954805269
ZINC391812

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
Actavis Labs Ny Inc NICOTINE POLACRILEX nicotine polacrilex GUM, CHEWING;BUCCAL 074707-001 Mar 19, 1999 OTC No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Actavis Labs Ny Inc NICOTINE POLACRILEX nicotine polacrilex GUM, CHEWING;BUCCAL 078699-001 Dec 29, 2008 OTC No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Pfizer Inc NICOTROL nicotine SPRAY, METERED;NASAL 020385-001 Mar 22, 1996 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Glaxosmithkline Cons NICORETTE nicotine polacrilex TROCHE/LOZENGE;ORAL 022360-001 May 18, 2009 OTC Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for nicotine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mcneil Cons NICOTROL nicotine FILM, EXTENDED RELEASE;TRANSDERMAL 020536-001 Jul 3, 1996 ➤ Sign Up ➤ Sign Up
Dr Reddys Labs Sa HABITROL nicotine FILM, EXTENDED RELEASE;TRANSDERMAL 020076-004 Nov 12, 1999 ➤ Sign Up ➤ Sign Up
Sanofi Aventis Us NICODERM CQ nicotine FILM, EXTENDED RELEASE;TRANSDERMAL 020165-005 Aug 2, 1996 ➤ Sign Up ➤ Sign Up
Dr Reddys Labs Sa HABITROL nicotine FILM, EXTENDED RELEASE;TRANSDERMAL 020076-005 Nov 12, 1999 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for nicotine

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,622,136 Transparent transdermal nicotine delivery devices ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Cipla
Baxter
Moodys
Accenture
Queensland Health
Covington
McKinsey
Fish and Richardson
Boehringer Ingelheim

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 verifification 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.