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Last Updated: January 18, 2020

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NICORETTE Drug Profile

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Which patents cover Nicorette, and what generic alternatives are available?

Nicorette is a drug marketed by Glaxosmithkline and Glaxosmithkline Cons and is included in four NDAs. There are three patents protecting this drug and two Paragraph IV challenges.

This drug has forty-four patent family members in twenty-two countries.

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

US ANDA Litigation and Generic Entry Outlook for Nicorette

  Start Trial

A generic version of NICORETTE was approved as nicotine polacrilex by P AND L on January 18th, 2020.

Drug patent expirations by year for NICORETTE
Drug Prices for NICORETTE

See drug prices for NICORETTE

Recent Clinical Trials for NICORETTE

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

SponsorPhase
GlaxoSmithKlinePhase 1
Janssen (China) Research & Development CenterPhase 1
McNeil ABPhase 1

See all NICORETTE clinical trials

Synonyms for NICORETTE
(-)-.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-(1-Methyl-2-pyrrolidyl)pyridine
(-)-3-(N-Methylpyrrolidino)pyridine
(-)-Nicotine
(-)-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
(2S) 3-(1-Methyl-pyrrolidin-2-yl)-pyridine
(S)-(-)--nicotine
(S)-(-)-Nicotine
(S)-(-)-NICOTINE, 3-[(2S)-1-METHYL-2-PYRROLIDINYL] PYRIDINE
(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
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-METHYL-2-PYRROLIDINYL] 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
alpha-N-methylpyrrolidine
AN-24414
BDBM82070
beta-Pyridyl-alpha-N-methyl pyrrolidine
beta-Pyridyl-alpha-N-methylpyrrolidine
BIDD:GT0599
Black leaf
bmse000105
BRD-K05395900-322-02-1
BRD-K05395900-322-04-7
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
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)
HMS2230H17
HMS3259E16
HSDB 1107
HY-B0638
I14-111388
J-500021
L-3-(1-Methyl-2-pyrrolidyl)pyridine
L-Nicotine
L-Nicotine, 99+%
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, Nicotrol
Nicotin
Nicotina
Nicotina [Italian]
nicotine
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 alkaloid
NICOTINE AND SALTS
Nicotine betadex
Nicotine Difartrate
Nicotine Patch
Nicotine polacrilex
Nicotine polacrilex [USAN]
nicotine replacement patch
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)-
Pyridine, 3-[(2S)-1-methyl-2-pyrrolidinyl]-
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 solution, 1.0 mg/mL in methanol, ampule of 1 mL, certified reference material
SAM002564224
SB12751
SBB012359
SBI-0050785.P003
SC-58411
SCHEMBL20192
SDCCGMLS-0066911.P001
SMR000059074
SNICXCGAKADSCV-JTQLQIEISA-N
SR-05000001762-5
ST069320
Tabazur
Tendust
Tetrahydronicotyrine, DL-
Tox21_201814
Tox21_300174
Transdermal Nicotine
UN1654
UNII-6M3C89ZY6R
XL All Insecticide
Z1954805269
ZINC391812
Paragraph IV (Patent) Challenges for NICORETTE
Tradename Dosage Ingredient NDA Submissiondate
NICORETTE TROCHE/LOZENGE;ORAL nicotine polacrilex 022360 2015-12-02

US Patents and Regulatory Information for NICORETTE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline NICORETTE nicotine polacrilex GUM, CHEWING;BUCCAL 018612-002 Feb 9, 1996 OTC Yes No   Start Trial   Start Trial   Start Trial
Glaxosmithkline Cons NICORETTE nicotine polacrilex TROCHE/LOZENGE;ORAL 022360-001 May 18, 2009 OTC Yes No   Start Trial   Start Trial Y   Start Trial
Glaxosmithkline NICORETTE nicotine polacrilex GUM, CHEWING;BUCCAL 020066-004 Sep 25, 2000 OTC Yes No   Start Trial   Start Trial   Start Trial
Glaxosmithkline NICORETTE (MINT) nicotine polacrilex GUM, CHEWING;BUCCAL 020066-003 Dec 23, 1998 OTC Yes No   Start Trial   Start Trial   Start Trial
Glaxosmithkline Cons NICORETTE nicotine polacrilex TROCHE/LOZENGE;ORAL 021330-002 Oct 31, 2002 OTC Yes Yes   Start Trial   Start Trial   Start 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 NICORETTE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline Cons NICORETTE nicotine polacrilex TROCHE/LOZENGE;ORAL 022360-002 May 18, 2009   Start Trial   Start Trial
Glaxosmithkline Cons NICORETTE nicotine polacrilex TROCHE/LOZENGE;ORAL 021330-001 Oct 31, 2002   Start Trial   Start Trial
Glaxosmithkline Cons NICORETTE nicotine polacrilex TROCHE/LOZENGE;ORAL 022360-001 May 18, 2009   Start Trial   Start Trial
Glaxosmithkline Cons NICORETTE nicotine polacrilex TROCHE/LOZENGE;ORAL 021330-002 Oct 31, 2002   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Colorcon
Medtronic
McKinsey
Mallinckrodt
Merck

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