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Generated: May 27, 2018

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Erlotinib hydrochloride - Generic Drug Details

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What are the generic sources for erlotinib hydrochloride and what is the scope of erlotinib hydrochloride freedom to operate?

Erlotinib hydrochloride
is the generic ingredient in two branded drugs marketed by Mylan Pharms Inc, Teva Pharms Usa, and Osi Pharms, and is included in three NDAs. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Erlotinib hydrochloride has one hundred and twenty-three patent family members in fifty countries.

There are twenty-five drug master file entries for erlotinib hydrochloride. Two suppliers are listed for this compound. There is one tentative approval for this compound.
Pharmacology for erlotinib hydrochloride
Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors
Medical Subject Heading (MeSH) Categories for erlotinib hydrochloride
Synonyms for erlotinib hydrochloride
(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 [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
Tarceva (Erlotinib Hydrochloride)
Tarceva (OSI)
tarceva hydrochloride
UNII-DA87705X9K
ZX-AFC000217
Tentative approvals for ERLOTINIB HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
➤ Try a Free Trial➤ Try a Free TrialEQ 100MG BASETABLET;ORAL
➤ Try a Free Trial➤ Try a Free TrialEQ 150MG BASETABLET;ORAL

US Patents and Regulatory Information for erlotinib hydrochloride

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 021743-003 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 021743-003 Nov 18, 2004 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ 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 021743-002 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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Supplementary Protection Certificates for erlotinib hydrochloride

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
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
C001/2006 Ireland ➤ Try a Free Trial SPC001/2006: 20070817, EXPIRES: 20200320
209 Luxembourg ➤ Try a Free Trial 91209, EXPIRES: 20200321
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
Accenture
Federal Trade Commission
Cerilliant
Cipla
QuintilesIMS
Teva
Dow
AstraZeneca

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