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Last Updated: December 11, 2019

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TYKERB Drug Profile

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When do Tykerb patents expire, and what generic alternatives are available?

Tykerb is a drug marketed by Novartis and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and fifty-five patent family members in forty-eight countries.

The generic ingredient in TYKERB is lapatinib ditosylate. There are seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the lapatinib ditosylate profile page.

US ANDA Litigation and Generic Entry Outlook for Tykerb

Tykerb was eligible for patent challenges on March 13th, 2011.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 18th, 2029. This may change due to patent challenges or generic licensing.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Drug patent expirations by year for TYKERB
Drug Prices for TYKERB

See drug prices for TYKERB

Generic Entry Opportunity Date for TYKERB
Generic Entry Date for TYKERB*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for TYKERB

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

SponsorPhase
Scariot FoundationN/A
University of Alabama at BirminghamN/A
AbbVieN/A

See all TYKERB clinical trials

Pharmacology for TYKERB
Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors
Synonyms for TYKERB
0VUA21238F
1xkk
231277-92-2
277L922
388082-78-8
4-[[3-Chloro-4-(3-fluorobenzyloxy)phenyl]amino]-6-[5-[[(2-methanesulfonylethyl)amino]methyl]furan-2-yl]quinazoline
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]-
49311-EP2298768A1
49311-EP2298778A1
49311-EP2311840A1
913989-15-8
A25184
A3967
AB0005824
AB01273965_04
AB01273965_05
AB01273965-01
AB01273965-02
AB01273965-03
AB1004631
ABP000866
ABP000872
AC-1314
AC1L4LL4
AKOS005145766
AM20090641
AMX10154
AN-5195
AN-5300
AOB5254
API0003126
AS-14065
AX8135884
BC677691
BCFGMOOMADDAQU-UHFFFAOYSA-N
BCP01874
BCP9000837
BCP9000838
BCPP000188
BCPP000189
BDBM5445
BRD-K19687926-001-01-7
BRD-K19687926-379-02-5
C29H26ClFN4O4S
CAS-231277-92-2
CHEBI:49603
CHEMBL1076241
CHEMBL554
cid_208908
CM14421
D08108
DB01259
DSSTox_CID_26675
DSSTox_GSID_46675
DSSTox_RID_81812
DTXSID7046675
EN002712
EX-A402
FMM
FT-0659650
GSK 572016
GSK572016
GTPL5692
GW 282974X
GW 572016
GW-2016
GW-572016
GW572016
GW572016;GW-572016;GW 572016
HMS2089H10
HMS3244N06
HMS3244N10
HMS3244N14
HSDB 8209
HY-50898
I01-1247
J90020
KB-57365
Kinome_3684
Kinome_3685
KS-00000GH2
Lapatinib
Lapatinib (INN)
Lapatinib [INN:BAN]
Lapatinib [INN]
Lapatinib base
Lapatinib Ditosylate/
Lapatinib free base
Lapatinib tosilate hydrate
Lapatinib, Tykerb, GW572016
LS-187029
LS-187771
MFCD09264194
MolPort-006-069-221
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-(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
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]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
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
NCGC00167507-09
nchembio866-comp20
NSC-745750
NSC745750
PubChem7650
Q-101353
Q570
QCR-63
RL02729
SB16918
SC-02676
SCHEMBL8100
SR-05000001472-1
ST2407069
SW199101-5
SYN1052
TL80090051
Tox21_112505
Tox21_112505_1
Tycerb
Tykerb (TN) (Glaxo Smith Kline)
Tyverb
UNII-0VUA21238F
W-3749
ZINC1550477
Paragraph IV (Patent) Challenges for TYKERB
Tradename Dosage Ingredient NDA Submissiondate
TYKERB TABLET;ORAL lapatinib ditosylate 022059 2011-03-14

US Patents and Regulatory Information for TYKERB

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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis TYKERB lapatinib ditosylate TABLET;ORAL 022059-001 Mar 13, 2007   Start Trial   Start Trial
Novartis TYKERB lapatinib ditosylate TABLET;ORAL 022059-001 Mar 13, 2007   Start Trial   Start Trial
Novartis 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 TYKERB

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1047694 91475 Luxembourg   Start Trial 91475, EXPIRES: 20230610
1047694 37/2008 Austria   Start Trial PRODUCT NAME: LAPATINIB ALS FREIE BASE ODER EIN SALZ ODER EIN SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/07/440/001-002 20080610
1047694 122008000048 Germany   Start Trial PRODUCT NAME: LAPATINIB ODER EIN SALZ ODER SOLVAT DAVON; 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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Serving leading biopharmaceutical companies globally:

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Dow
Colorcon
AstraZeneca
Boehringer Ingelheim
McKesson

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.