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Last Updated: November 20, 2019

DrugPatentWatch Database Preview

TARCEVA Drug Profile

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

Tarceva is a drug marketed by Osi Pharms and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in TARCEVA is erlotinib hydrochloride. There are twenty-five drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the erlotinib hydrochloride profile page.

Drug patent expirations by year for TARCEVA
Drug Prices for TARCEVA

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Recent Clinical Trials for TARCEVA

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SponsorPhase
Alpha Biopharma (Jiangsu) Co., Ltd.Phase 2/Phase 3
Millennium: The Takeda Oncology CompanyPhase 1
Roche Korea co.,Ltd.Phase 2

See all TARCEVA clinical trials

Recent Litigation for TARCEVA

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District Court Litigation
Case NameDate
OSI Pharmaceuticals, LLC v. Zydus Pharmaceuticals (USA) Inc.2019-04-25
OSI Pharmaceuticals, LLC v. Shilpa Medicare Limited2018-07-25
OSI Pharmaceuticals, LLC v. Accord Healthcare Inc., USA2017-12-28

See all TARCEVA litigation

PTAB Litigation
PetitionerDate
Apotex, Inc.2016-06-28

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Pharmacology for TARCEVA
Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors
Synonyms for TARCEVA
(CP358774
[6,7-Bis(2-methoxy-ethoxy)-quinazolin-4-yl]-(3-ethynyl- phenyl)amine hydrochloride
183319-69-9
183319-69-9 pound not183321-74-6
319E699
4-(m-Ethynylanilino)-6,7-bis(2-methoxyethoxy)quinazoline hydrochloride
4-(m-Ethynylanilino)-6,7-bis(2-methoxyethoxy)quinazoline monohydrochloride
4-Quinazolinamine, N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)-, hydrochloride (1:1)
4-Quinazolinamine, N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)-, monohydrochloride
4CA-0509
6,7-Bis-(2-methoxyethoxy)-4-(3-ethynylanilino)quinazoline hydrochloride
6,7-bis(2-methoxyethoxy)-4-(3-ethynylanilino)quinazoline hcl
6,7-bis(2-methoxyethoxy)-4-(3-ethynylanilino)quinazoline hydrochloride
AB0044024
AB1008594
ABP000864
ABP001100
AC-400
AC1L42EJ
AK-75676
AKOS015849087
AM20090622
AN-1331
AOB87784
API0002588
BC215798
BCP02600
BCP9000658
BCPP000238
BIFK0020
BP-30224
BR-75676
C22H23N3O4.HCl
C22H24ClN3O4
CHEBI:53509
CHEMBL1079742
CP 358774
CP-358,774-01
CP-358774
CP-358774-01
CP-35877401
CS-0123
DA87705X9K
DTXSID10171412
E-4007
Erlotinib (Hydrochloride)
erlotinib HCl
Erlotinib HCl (OSI-744)
erlotinib hcl salt
Erlotinib HCl salt :Tarceva
Erlotinib hydrochloride
Erlotinib hydrochloride [USAN:INN]
Erlotinib hydrochloride [USAN]
Erlotinib Hydrochloride,CP-358774, OSI-774, NSC 718781
Erlotinib Hydrochloride/Tarceva,CP-358774
Erlotinib, HCl
erlotinib, hydrochloride salt
Erlotinib(OSI-744)
erlotonib hydrochloride
EX-A064
F0001-2385
FT-0083537
FT-0651479
GTTBEUCJPZQMDZ-UHFFFAOYSA-N
HY-12008
I01-1228
J10200
KB-3353980
KB-71675
KS-1202
LS-184396
M375
MCULE-9498970160
MFCD07781272
MLS003899192
MLS004774139
MolPort-003-850-391
N-(3-Ethynylphenyl)-6,7-bis(1-methoxyethoxy)-4-quinazolinamine hydrochloride
N-(3-ETHYNYLPHENYL)-6,7-BIS(2-METHOXYETHOXY)-4-QUINAZOLINAMINE HYDROCHLORIDE
N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)-4-quinazolinamine, monohydrochloride
N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)quinazolin-4-amine hydrochloride
N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)quinazolin-4-amine;hydrochloride
N-(3-Ethynylphenyl)[6,7-bis(2-methoxyethoxy)quinazolin-4-yl]amine hydrochloride
N-(3-Ethynylphenyl)[6,7-bis(2-methoxyethoxy)quinazolin-4-yl]amine hydrochloride; 6,7-Bis(2-methoxyethoxy)-4-(3-ethynylanilino)quinazoline hydrochloride
NSC 718781
NSC 718781) HCl
NSC-718781
NSC718781
OSI 774
OSI-774
PB30965
R-1415
RG-1415
Ro-50-8231
RS0032
s1023
SB16917
SC-18020
SMR002529980
ST2413548
SYN1039
Tarceva (Erlotinib Hydrochloride)
Tarceva (OSI)
tarceva hydrochloride
UNII-DA87705X9K
ZX-AFC000217
Paragraph IV (Patent) Challenges for TARCEVA
Tradename Dosage Ingredient NDA Submissiondate
TARCEVA TABLET;ORAL erlotinib hydrochloride 021743 2008-11-18

US Patents and Regulatory Information for TARCEVA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Osi Pharms TARCEVA erlotinib hydrochloride TABLET;ORAL 021743-001 Nov 18, 2004 AB RX Yes No   Start Trial   Start Trial   Start Trial
Osi Pharms TARCEVA erlotinib hydrochloride TABLET;ORAL 021743-003 Nov 18, 2004 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Osi Pharms TARCEVA erlotinib hydrochloride TABLET;ORAL 021743-001 Nov 18, 2004 AB RX Yes No   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 TARCEVA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Osi Pharms TARCEVA erlotinib hydrochloride TABLET;ORAL 021743-002 Nov 18, 2004   Start Trial   Start Trial
Osi Pharms TARCEVA erlotinib hydrochloride TABLET;ORAL 021743-001 Nov 18, 2004   Start Trial   Start Trial
Osi Pharms TARCEVA erlotinib hydrochloride TABLET;ORAL 021743-003 Nov 18, 2004   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for TARCEVA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0817775 CA 2006 00006 Denmark   Start Trial
0817775 SPC/GB06/008 United Kingdom   Start Trial PRODUCT NAME: ERLOTINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT OR POLYMORPH THEREOF, IN PARTICULAR THE HYDROCHLORIDE SALT; REGISTERED: CH 5726601 20050321; CH 5726602 20050321; CH 5726603 20050321; UK EU/1/05/311/001 20050919; UK EU/1/05/311/002 20050919; UK EU/1/05/311/003 20050919
0817775 5/2006 Austria   Start Trial PRODUCT NAME: ERLOTINIB UND SEINE PHARMAZEUTISCH ANNEHMBAREN SALZE, INSBESONDERE ERLOTINIBHYDROCHLORID; NAT. REGISTRATION NO/DATE: EU/1/05/311/001 - EU/1/05/311/003 20050919; FIRST REGISTRATION: CH 57266 01 - 57266 03 20050321
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Moodys

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