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Last Updated: October 21, 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 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.

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   Start Trial   Start Trial Y Y   Start Trial
Novartis Pharms Corp TYKERB lapatinib ditosylate TABLET;ORAL 022059-001 Mar 13, 2007 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Novartis Pharms Corp TYKERB lapatinib ditosylate TABLET;ORAL 022059-001 Mar 13, 2007 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Novartis Pharms Corp TYKERB lapatinib ditosylate TABLET;ORAL 022059-001 Mar 13, 2007 RX Yes Yes   Start Trial   Start Trial Y Y   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 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   Start Trial   Start Trial
Novartis Pharms Corp TYKERB lapatinib ditosylate TABLET;ORAL 022059-001 Mar 13, 2007   Start Trial   Start Trial
Novartis Pharms Corp TYKERB lapatinib ditosylate TABLET;ORAL 022059-001 Mar 13, 2007   Start Trial   Start Trial
Novartis Pharms Corp TYKERB lapatinib ditosylate TABLET;ORAL 022059-001 Mar 13, 2007   Start Trial   Start Trial
>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   Start Trial PRODUCT NAME: LAPATINIBUM DITOSYLATUM MONOHYDRICUM; REG. NO/DATE: EU/1/07/440/001-002 20080610
1047694 CA 2008 00040 Denmark   Start Trial PRODUCT NAME: LAPATINIB ELLER ET SALT ELLER SOLVAT DERAF, HERUNDER LAPATINIBDITOSYLATMONOHYDRAT
1047694 SPC026/2008 Ireland   Start Trial SPC026/2008: 20091118, EXPIRES: 20230609
1047694 08C0038 France   Start Trial 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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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.