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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
Cerilliant
McKesson
McKinsey
Express Scripts
Medtronic
Citi
QuintilesIMS
Accenture

Generated: May 23, 2018

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-three patent family members in fifty countries.

The generic ingredient in TARCEVA is erlotinib hydrochloride. There are twenty-five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the erlotinib hydrochloride profile page.
Drug patent expirations by year for TARCEVA
Pharmacology for TARCEVA
Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors
Medical Subject Heading (MeSH) Categories for TARCEVA
Synonyms for TARCEVA
(CP358774
[6,7-BIS-(2-METHOXY-ETHOXY)-QUINAZOLIN-4-YL]-(3-ETHYNYL-PHENYL)-AMINE HYDROCHLORIDE
[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
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
BCP9000658
BCPP000238
BIFK0020
Bio-0036
BP-30224
BR-75676
C22H23N3O4.HCl
C22H24ClN3O4
CHEBI:53509
CHEMBL1079742
CP 358774
CP-358,774-01
CP-358774
CP-358774 HYDROCHLORIDE
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, hydrochloride salt
Erlotinib(OSI-744)
erlotinibhydrochloride
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 (1:1)
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
OSI-774 HYDROCHLORIDE
PB30965
R-1415
RG-1415
Ro-50-8231
RS0032
s1023
SC-18020
SMR002529980
ST2413548
SYN1039
Tarceva (Erlotinib Hydrochloride)
Tarceva (OSI)
tarceva hydrochloride
UNII-DA87705X9K
ZX-AFC000217

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 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Osi Pharms TARCEVA erlotinib hydrochloride TABLET;ORAL 021743-003 Nov 18, 2004 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Osi Pharms TARCEVA erlotinib hydrochloride TABLET;ORAL 021743-001 Nov 18, 2004 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Osi Pharms TARCEVA erlotinib hydrochloride TABLET;ORAL 021743-001 Nov 18, 2004 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
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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Paragraph IV (Patent) Challenges for TARCEVA
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Tablets 25 mg, 100 mg and 150 mg ➤ Subscribe 2008-11-18

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Supplementary Protection Certificates for TARCEVA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB06/008 United Kingdom ➤ Try a Free 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
2006 Austria ➤ Try a Free 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
209 Luxembourg ➤ Try a Free Trial 91209, EXPIRES: 20200321
00214 Netherlands ➤ Try a Free Trial PRODUCT NAME: ERLOTINIB, DESGEWENST IN DE; REGISTRATION NO/DATE: 57266 01,..02,..03EU/1/05/311/001...003 20050321
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Healthtrust
Argus Health
US Department of Justice
Cantor Fitzgerald
QuintilesIMS
Julphar
Mallinckrodt
Citi
Boehringer Ingelheim

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