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Generated: November 20, 2018

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Lapatinib ditosylate - Generic Drug Details

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

Lapatinib ditosylate is the generic ingredient in one branded drug marketed by Novartis Pharms Corp and is included in one NDA. There are five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for lapatinib ditosylate. One supplier is listed for this compound.

Pharmacology for lapatinib ditosylate
Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors
Synonyms for lapatinib ditosylate
0VUA21238F
1xkk
231277-92-2
277L922
388082-77-7
388082-78-8
4-[[3-Chloro-4-(3-fluorobenzyloxy)phenyl]amino]-6-[5-[[(2-methanesulfonylethyl)amino]methyl]furan-2-yl]quinazoline
4-[[3-Chloro-4-(3-fluorobenzyloxy)phenyl]amino]-6-[5-[[(2-methanesulfonylethyl)amino]methyl]furan-2-yl]quinazoline; GSK572016; GW 572016; GW 572016X; Lapatinib; N-[3-Chloro-4-[(3-fluorobenzyl)oxy]phenyl]-6-[5-[[[2-(methanesul
4-Quinazolinamine, N-(3-chloro-4-((3-fluorophenyl)methoxy)phenyl)-6-(5-(((2-(methylsulfonyl)ethyl)amino)methyl)-2-furanyl)-
4-Quinazolinamine, N-(3-chloro-4-((3-fluorophenyl)methoxy)phenyl)-6-(5-(((2-(methylsulfonyl)ethyl)amino)methyl)-2-furanyl)-, bis(4-methylbenzenesulfonate)
4-Quinazolinamine, N-[3-chloro-4-[(3-fluorophenyl)methoxy]phenyl]-6-[5-[[[2-(methylsulfonyl)ethyl]amino]methyl]-2-furanyl]-
4-QUINAZOLINAMINE, N-[3-CHLORO-4-[(3-FLUOROPHENYL)METHOXY]PHENYL]-6-[5-[[[2-(METHYLSULFONYL)ETHYL]AMINO]METHYL]-2-FURANYL]-, DI-4-METHYLBENZENESULFONATE
49311-EP2298768A1
49311-EP2298778A1
49311-EP2311840A1
4CH-007412
4WK72K94MC
913989-15-8
A25184
AB0005824
AB0006354
AB01273965_04
AB01273965_05
AB01273965-01
AB01273965-02
AB01273965-03
AB1004631
ABP000866
ABP000872
AC-1314
AC-5247
AC1L4LL4
AK-46487
AK-47669
AKOS005145766
AKOS015888607
AM20090641
AMX10154
AN-5195
AN-5300
AOB5252
AOB5254
API0003126
AS-14065
AX8135884
BC677691
BCFGMOOMADDAQU-UHFFFAOYSA-N
BCP9000837
BCP9000838
BCPP000188
BCPP000189
BDBM5445
bis(4-methylbenzene-1-sulfonic acid); N-{3-chloro-4-[(3-fluorophenyl)methoxy]phenyl}-6-(5-{[(2-methanesulfonylethyl)amino]methyl}furan-2-yl)quinazolin-4-amine
BR-47669
BRD-K19687926-001-01-7
C29H26ClFN4O4S
C29H26ClFN4O4S.2C7H8O3S
CAS-231277-92-2
CHEBI:49603
CHEMBL1076241
CHEMBL554
cid_208908
CM14421
CS-0831
CTK8E9246
D08108
D08CDI
DB01259
DSSTox_CID_26675
DSSTox_GSID_46675
DSSTox_RID_81812
DTXSID7046675
EN002712
EX-A402
FMM
FT-0659650
FT-0670728
GS-3661
GSK 572016
GSK572016
GTPL5692
GW 282974X
GW 572016
GW 572016 ditosylate
GW 572016 ditosylate;GW-572016 ditosylate
GW 572016F
GW 572016X
GW-2016
GW-57201
GW-572016
GW-572016F Ditosylate
GW572016
GW572016;GW-572016;GW 572016
GW572016F
HE072024
HE327087
HE340258
HMS2089H10
HMS3244N06
HMS3244N10
HMS3244N14
HMS3265I13
HMS3265I14
HMS3265J13
HMS3265J14
HMS3654E07
HY-50898
HY-50898A
I01-1224
I01-1247
J90020
KB-57365
Kinome_3684
Kinome_3685
KS-00000GH2
KS-00000GH3
Lapatinib
LAPATINIB (DITOSYLATE SALT)
Lapatinib (ditosylate)
Lapatinib (ERBB2 inhibitor)
Lapatinib (GW-572016) Ditosylate
Lapatinib (INN)
Lapatinib [INN]
Lapatinib base
lapatinib bis(para-toluene sulfonate)
Lapatinib ditasylate
Lapatinib Ditosilate
lapatinib ditosilate hydrate
Lapatinib ditosylate anhydrous
Lapatinib Ditosylate,Tykerb
Lapatinib Ditosylate/
Lapatinib free base
lapatinib tosilate
Lapatinib tosilate hydrate
LAPATINIB TOSYLATE
LAPATINIB, DI-P-TOLUENESULFONATE SALT
Lapatinib, Tykerb, GW572016
lapatinib; bis(p-toluenesulfonic acid)
LapatinibDitosylate
LS-187029
LS-187771
MFCD09264194
MolPort-006-069-221
MolPort-008-155-959
N-(3-chloro-4-((3-fluorobenzyl)oxy)phenyl)-6-(5-(((2-(methylsulfonyl)ethyl)amino)methyl)furan-2-yl)quinazolin-4-amine
N-(3-Chloro-4-((3-fluorobenzyl)oxy)phenyl)-6-(5-(((2-(methylsulfonyl)ethyl)amino)methyl)furan-2-yl)quinazolin-4-amine bis(4-methylbenzenesulfona
N-(3-CHLORO-4-((3-FLUOROBENZYL)OXY)PHENYL)-6-(5-(((2-(METHYLSULFONYL)ETHYL)AMINO)METHYL)FURAN-2-YL)QUINAZOLIN-4-AMINE BIS(4-METHYLBENZENESULFONATE)
N-(3-chloro-4-((3-fluorophenyl)methoxy)phenyl)-6-(5-(((2-(methylsulfonyl)ethyl)amino)methyl)-2-furanyl)-4-quinazolinamine
N-(3-Chloro-4-((3-fluorophenyl)methoxy)phenyl)-6-(5-((2-methylsulfonylethylamino)methyl)-2-furyl)quinazolin-4-amine
N-(3-chloro-4-(3-fluorobenzyloxy)phenyl)-6-(5-((2-(methylsulfonyl) ethylamino)methyl)furan-2-yl)quinazolin-4-amine ditosylate
N-(3-chloro-4-(3-fluorobenzyloxy)phenyl)-6-(5-((2-(methylsulfonyl)ethylamino)methyl)furan-2-yl)quinazolin-4-amine
N-(3-chloro-4-(3-fluorobenzyloxy)phenyl)-6-(5-((2-(methylsulfonyl)ethylamino)methyl)furan-2-yl)quinazolin-4-amine ditosylate
N-(3-Chloro-4-{[(3-fluorophenyl)methyl]oxy}phenyl)-6-[5-({[2-(methylsulfonyl)ethyl]amino}methyl)-2-furanyl]-4-quinazolinamine
N-[3-chloro-4-(3-fluorobenzyloxy)phenyl]-6-[5-({[2-(methanesulfonyl)ethyl]amino}methyl)furan-2-yl]quinazolin-4-amine
N-[3-Chloro-4-[(3-fluorobenzyl)oxy]phenyl]-6-[5-({[2-(methanesulphonyl)ethyl]amino}methyl)-2-furyl]-4-quinazolinamine
N-[3-chloro-4-[(3-fluorophenyl)methoxy]phenyl]-6-[5-[(2-methylsulfonylethylamino)methyl]-2-furyl] quinazolin-4-amine
N-[3-Chloro-4-[(3-fluorophenyl)methoxy]phenyl]-6-[5-[(2-methylsulfonylethylamino)methyl]-2-furyl]quinazolin-4-amine
N-[3-CHLORO-4-[(3-FLUOROPHENYL)METHOXY]PHENYL]-6-[5-[(2-METHYLSULFONYLETHYLAMINO)METHYL]-2-FURYL]QUINAZOLIN-4-AMINE DITOSYLATE
N-[3-chloro-4-[(3-fluorophenyl)methoxy]phenyl]-6-[5-[(2-methylsulfonylethylamino)methyl]furan-2-yl]quinazolin-4-amine
N-[3-Chloro-4-[(3-fluorophenyl)methoxy]phenyl]-6-[5-[[[2-(methylsulfonyl)ethyl]amino]methyl]-2-furanyl]-4-quinazolinamine Bis(4-methylbenzenesulfonate) Ditosylate
N-{3-chloro-4-[(3-fluoro-benzyl)oxy]phenyl}-6-[5-({2-(methylsulfonyl)ethyl]amino}methyl)-2-furyl]-4-quinazolinamine
N-{3-Chloro-4-[(3-fluorobenzyl)oxy]phenyl}-6-[5-({[2-(methane sulphonyl)ethyl]amino}methyl)-2-furyl]-4-quinazolinamine
N-{3-Chloro-4-[(3-fluorobenzyl)oxy]phenyl}-6-[5-({[2-(methanesulphonyl)ethyl]amino}methyl)-2-furyl]-4-quinazolinamine
N-{3-CHLORO-4-[(3-FLUOROBENZYL)OXY]PHENYL}-6-[5-({[2-(METHYLSULFONYL)ETHYL]AMINO}METHYL)-2-FURYL]-4-QUINAZOLINAMINE
N-{3-chloro-4-[(3-fluorobenzyl)oxy]phenyl}-6-[5-({[2-(methylsulfonyl)ethyl]amino}methyl)furan-2-yl]quinazolin-4-amine
N-{3-chloro-4-[(3-fluorophenyl)methoxy]phenyl}-6-(5-{[(2-methanesulfonylethyl)amino]methyl}furan-2-yl)quinazolin-4-amine
N-{3-Chloro-4[(3-fluorobenzyl)oxy]phenyl}-6-[5-({[2-(methane sulphonyl)ethyl]amino}methyl)-2-furyl]-4-quinazolinamine
N3-Chloro-4-(3-fluorophenyl)methoxyphenyl-6-5-(2-methylsulfonylethylamino)methyl-2-furylquinazolin-4-amine
NCGC00167507-01
NCGC00167507-02
NCGC00167507-03
NCGC00167507-04
nchembio866-comp20
NSC-745750
NSC745750
PubChem7650
Q-101353
Q570
QCR-63
RL02729
RTR-015625
S-4736
SC-02676
SC-95137
SCHEMBL8100
SCHEMBL93590
SR-05000001472
SR-05000001472-5
ST24031317
ST2407069
SYN1052
TL80090051
Tox21_112505
Tox21_112505_1
TR-015625
Tycerb
Tykerb
Tykerb (TN)
Tykerb (TN) (Glaxo Smith Kline)
Tykerb Ditosylate
Tyverb
Tyverb|||Tykerb
UNII-0VUA21238F
UNII-4WK72K94MC
UWYXLGUQQFPJRI-UHFFFAOYSA-N
W-3749
YF10107
Z1692482592
ZINC1550477

US Patents and Regulatory Information for lapatinib ditosylate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis Pharms Corp TYKERB lapatinib ditosylate TABLET;ORAL 022059-001 Mar 13, 2007 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Novartis Pharms Corp TYKERB lapatinib ditosylate TABLET;ORAL 022059-001 Mar 13, 2007 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Novartis Pharms Corp TYKERB lapatinib ditosylate TABLET;ORAL 022059-001 Mar 13, 2007 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Novartis Pharms Corp TYKERB lapatinib ditosylate TABLET;ORAL 022059-001 Mar 13, 2007 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Novartis Pharms Corp TYKERB lapatinib ditosylate TABLET;ORAL 022059-001 Mar 13, 2007 RX Yes Yes ➤ Sign Up ➤ Sign Up Y 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 lapatinib ditosylate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis Pharms Corp TYKERB lapatinib ditosylate TABLET;ORAL 022059-001 Mar 13, 2007 ➤ Sign Up ➤ Sign Up
Novartis Pharms Corp TYKERB lapatinib ditosylate TABLET;ORAL 022059-001 Mar 13, 2007 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Supplementary Protection Certificates for lapatinib ditosylate

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2008012,C1047694 Lithuania ➤ Sign Up PRODUCT NAME: LAPATINIBUM DITOSYLATUM MONOHYDRICUM; REGISTRATION NO/DATE: EU/1/07/440/001, 2008-06-10 EU/1/07/440/002 20080610
2008012 Lithuania ➤ Sign Up PRODUCT NAME: LAPATINIBUM DITOSYLATUM MONOHYDRICUM; REG. NO/DATE: EU/1/07/440/001-002 20080610
C/GB08/044 United Kingdom ➤ Sign Up PRODUCT NAME: LAPATINIB OR A SALT OR SOLVATE THEREOF; REGISTERED: UK EU/1/07/440/001 20080610; UK EU/1/07/440/002 20080610
2008000048 Germany ➤ Sign Up PRODUCT NAME: LAPATINIB ODER EIN SALZ ODER SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/07/440/001-002 20080610
C026/2008 Ireland ➤ Sign Up SPC026/2008: 20091118, EXPIRES: 20230609
2008 00040 Denmark ➤ Sign Up PRODUCT NAME: LAPATINIB ELLER ET SALT ELLER SOLVAT DERAF, HERUNDER LAPATINIBDITOSYLATMONOHYDRAT
1 Finland ➤ Sign Up
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Cerilliant
Express Scripts
Johnson and Johnson
Argus Health
McKinsey
UBS
Dow
Deloitte

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