Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 13, 2019

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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 freedom to operate?

Erlotinib hydrochloride is the generic ingredient in two branded drugs marketed by Mylan, 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-five patent family members in fifty-one countries.

There are twenty-five drug master file entries for erlotinib hydrochloride. Four suppliers are listed for this compound. There are two tentative approvals for this compound.

Recent Clinical Trials for erlotinib hydrochloride

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SponsorPhase
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityPhase 2
Tianjin Medical University Cancer Institute and HospitalPhase 3
Rong TaoPhase 2

See all erlotinib hydrochloride clinical trials

Recent Litigation for erlotinib hydrochloride

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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 erlotinib hydrochloride litigation

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

See all erlotinib hydrochloride litigation

Generic filers with tentative approvals for ERLOTINIB HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
  Start Trial  Start TrialEQ 150MG BASETABLET;ORAL
  Start Trial  Start TrialEQ 100MG BASETABLET;ORAL
  Start Trial  Start TrialEQ 150MG BASETABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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
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 [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
Tarceva (Erlotinib Hydrochloride)
Tarceva (OSI)
tarceva hydrochloride
UNII-DA87705X9K
ZX-AFC000217
Paragraph IV (Patent) Challenges for ERLOTINIB HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
TARCEVA TABLET;ORAL erlotinib hydrochloride 021743 2008-11-18

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 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
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 021743-001 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 erlotinib hydrochloride

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

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0817775 C300214 Netherlands   Start Trial PRODUCT NAME: ERLOTINIB, DESGEWENST IN DE; REGISTRATION NO/DATE: 57266 01,..02,..03EU/1/05/311/001...003 20050321
0817775 300214 Netherlands   Start Trial 300214, 20150606, EXPIRES: 20200320
0817775 06C0010 France   Start Trial PRODUCT NAME: ERLOTINIB HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: EU/1/05/311/001 20050919; FIRST REGISTRATION: LI - 57266 20050321
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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