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Last Updated: March 31, 2020

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ERLOTINIB HYDROCHLORIDE Drug Profile


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

Erlotinib Hydrochloride is a drug marketed by Apotex, Mylan, Natco Pharma Ltd, Shilpa Medicare Ltd, Sun Pharm, and Teva Pharms Usa. and is included in six NDAs.

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

US ANDA Litigation and Generic Entry Outlook for Erlotinib Hydrochloride

A generic version of ERLOTINIB HYDROCHLORIDE was approved as erlotinib hydrochloride by MYLAN on June 11th, 2014.

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Drug patent expirations by year for ERLOTINIB HYDROCHLORIDE
Recent Clinical Trials for ERLOTINIB HYDROCHLORIDE

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

SponsorPhase
University of Texas Southwestern Medical CenterPhase 2
Indiana UniversityPhase 1
Butler UniversityPhase 1

See all ERLOTINIB HYDROCHLORIDE clinical trials

Recent Litigation for ERLOTINIB HYDROCHLORIDE

Identify potential future generic entrants

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
2016-06-28

See all ERLOTINIB HYDROCHLORIDE litigation

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 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
AK-75676
AKOS015849087
AM20090622
AOB87784
API0002588
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
DB-011534
DTXSID10171412
E-4007
EC-000.2313
Erlotinib (Hydrochloride)
erlotinib HCl
Erlotinib HCl (OSI-744)
erlotinib hcl salt
Erlotinib hydrochloride [USAN:INN]
Erlotinib hydrochloride [USAN]
Erlotinib Hydrochloride,CP-358774, OSI-774, NSC 718781
Erlotinib Hydrochloride/Tarceva,CP-358774
Erlotinib-Hydrochloride
Erlotinib, HCl
erlotinib, hydrochloride salt
Erlotinib(OSI-744)
erlotonib hydrochloride
EX-A064
F0001-2385
FT-0083537
FT-0651479
GTTBEUCJPZQMDZ-UHFFFAOYSA-N
HY-12008
J10200
KS-1202
LS-184396
M375
MCULE-9498970160
MFCD07781272
MLS003899192
MLS004774139
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--hydrogen chloride (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
PB30965
Q27124083
R-1415
RG-1415
Ro-50-8231
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
Apotex ERLOTINIB HYDROCHLORIDE erlotinib hydrochloride TABLET;ORAL 208396-001 Nov 5, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Natco Pharma Ltd ERLOTINIB HYDROCHLORIDE erlotinib hydrochloride TABLET;ORAL 208488-001 Nov 5, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan ERLOTINIB HYDROCHLORIDE erlotinib hydrochloride TABLET;ORAL 091002-001 Jun 11, 2014 AB RX No No   Start Trial   Start Trial   Start Trial
Shilpa Medicare Ltd ERLOTINIB HYDROCHLORIDE erlotinib hydrochloride TABLET;ORAL 211960-003 Nov 5, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Natco Pharma Ltd ERLOTINIB HYDROCHLORIDE erlotinib hydrochloride TABLET;ORAL 208488-002 Nov 5, 2019 AB RX No 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

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
McKesson
Dow
Merck
Baxter
AstraZeneca

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