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Last Updated: October 15, 2019

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Lapatinib ditosylate - Generic Drug Details

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What are the generic sources for lapatinib ditosylate and what is the scope of patent protection?

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.

Lapatinib ditosylate has one hundred and fifty-five patent family members in forty-eight countries.

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

Summary for lapatinib ditosylate
Recent Clinical Trials for lapatinib ditosylate

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

SponsorPhase
Stanford UniversityPhase 2
Jonsson Comprehensive Cancer CenterPhase 1/Phase 2
Washington University School of MedicinePhase 2

See all lapatinib ditosylate clinical trials

Pharmacology for lapatinib ditosylate
Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors
Synonyms for lapatinib ditosylate
388082-77-7
388082-78-8
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]-, DI-4-METHYLBENZENESULFONATE
4CH-007412
4WK72K94MC
AB0006354
AC-5247
AK-47669
AKOS015888607
AOB5252
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
C29H26ClFN4O4S.2C7H8O3S
CS-0831
CTK8E9246
FT-0670728
GS-3661
GW 572016 ditosylate
GW 572016 ditosylate;GW-572016 ditosylate
GW 572016F
GW-57201
GW-572016
GW-572016F Ditosylate
HMS3265I13
HMS3265I14
HMS3265J13
HMS3265J14
HMS3654E07
HY-50898A
I01-1224
KS-00000GH3
LAPATINIB (DITOSYLATE SALT)
Lapatinib (ditosylate)
Lapatinib (GW-572016) Ditosylate
lapatinib bis(para-toluene sulfonate)
Lapatinib ditasylate
Lapatinib ditosylate anhydrous
Lapatinib Ditosylate,Tykerb
LAPATINIB, DI-P-TOLUENESULFONATE SALT
lapatinib; bis(p-toluenesulfonic acid)
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 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-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 ditosylate
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-(methylsulfonyl)ethyl]amino]methyl]-2-furanyl]-4-quinazolinamine Bis(4-methylbenzenesulfonate) Ditosylate
RTR-015625
S-4736
SC-95137
SCHEMBL93590
SR-05000001472
SR-05000001472-2
SR-05000001472-5
ST24031317
SW199101-4
TR-015625
Tykerb
Tykerb Ditosylate
Tyverb
Tyverb|||Tykerb
UNII-4WK72K94MC
UWYXLGUQQFPJRI-UHFFFAOYSA-N
YF10107
Z1692482592

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   See Pricing   See Pricing Y Y   See Pricing
Novartis Pharms Corp TYKERB lapatinib ditosylate TABLET;ORAL 022059-001 Mar 13, 2007 RX Yes Yes   See Pricing   See Pricing   See Pricing
Novartis Pharms Corp TYKERB lapatinib ditosylate TABLET;ORAL 022059-001 Mar 13, 2007 RX Yes Yes   See Pricing   See Pricing Y Y   See Pricing
Novartis Pharms Corp TYKERB lapatinib ditosylate TABLET;ORAL 022059-001 Mar 13, 2007 RX Yes Yes   See Pricing   See Pricing Y Y   See Pricing
Novartis Pharms Corp TYKERB lapatinib ditosylate TABLET;ORAL 022059-001 Mar 13, 2007 RX Yes Yes   See Pricing   See Pricing Y Y   See Pricing
Novartis Pharms Corp TYKERB lapatinib ditosylate TABLET;ORAL 022059-001 Mar 13, 2007 RX Yes Yes   See Pricing   See Pricing Y Y   See Pricing
>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 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   See Pricing   See Pricing
Novartis Pharms Corp TYKERB lapatinib ditosylate TABLET;ORAL 022059-001 Mar 13, 2007   See Pricing   See Pricing
Novartis Pharms Corp TYKERB lapatinib ditosylate TABLET;ORAL 022059-001 Mar 13, 2007   See Pricing   See Pricing
Novartis Pharms Corp TYKERB lapatinib ditosylate TABLET;ORAL 022059-001 Mar 13, 2007   See Pricing   See Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for lapatinib ditosylate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1047694 PA2008012 Lithuania   See Pricing PRODUCT NAME: LAPATINIBUM DITOSYLATUM MONOHYDRICUM; REG. NO/DATE: EU/1/07/440/001-002 20080610
1047694 331 Finland   See Pricing
1047694 122008000048 Germany   See Pricing PRODUCT NAME: LAPATINIB ODER EIN SALZ ODER SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/07/440/001-002 20080610
1047694 300360 Netherlands   See Pricing DETAILS ASSIGNMENT: VERANDERING VAN EIGENAAR(S), OVERDRACHT
1047694 37/2008 Austria   See Pricing PRODUCT NAME: LAPATINIB ALS FREIE BASE ODER EIN SALZ ODER EIN SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/07/440/001-002 20080610
1047694 PA 2008012, C1047694 Lithuania   See Pricing PRODUCT NAME: LAPATINIBUM DITOSYLATUM MONOHYDRICUM; FIRST REGISTRATION NO/DATE: EU/1/07/440/001-002 20080610
1047694 08C0038 France   See Pricing PRODUCT NAME: LAPATINIB OU UN DE SES SELS OU PRODUITS DE SOLVATATION; REGISTRATION NO/DATE: EU/1/07/440/001-002 20080610
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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