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Serving leading biopharmaceutical companies globally:

Cerilliant
Boehringer Ingelheim
Mallinckrodt
AstraZeneca
Federal Trade Commission
Chubb
Daiichi Sankyo
Cantor Fitzgerald
McKinsey
Fuji

Generated: October 19, 2017

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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, Osi Pharms, and Teva Pharms Usa, 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-four patent family members in fifty countries and nine supplementary protection certificates in eight countries.

There are twenty-three drug master file entries for erlotinib hydrochloride. Three suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: erlotinib hydrochloride

US Patents:4
Tradenames:2
Applicants:3
NDAs:3
Drug Master File Entries: see list23
Suppliers / Packagers: see list3
Bulk Api Vendors: see list72
Clinical Trials: see list2,870
Patent Applications: see list12
Therapeutic Class:Antineoplastics
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:erlotinib hydrochloride at DailyMed

Pharmacology for Ingredient: erlotinib hydrochloride

Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors

Tentative approvals for ERLOTINIB HYDROCHLORIDE

Applicant Application No. Strength Dosage Form
u► SubscribeEQ 100MG BASETABLET;ORAL
u► SubscribeEQ 150MG BASETABLET;ORAL
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;ORAL021743-003Nov 18, 2004RXYesYes► Subscribe► SubscribeY► Subscribe
Osi Pharms
TARCEVA
erlotinib hydrochloride
TABLET;ORAL021743-003Nov 18, 2004RXYesYes► Subscribe► SubscribeY► Subscribe
Teva Pharms Usa
ERLOTINIB HYDROCHLORIDE
erlotinib hydrochloride
TABLET;ORAL091059-003Aug 28, 2015DISCNNoNo► Subscribe► Subscribe► Subscribe
Mylan Pharms Inc
ERLOTINIB HYDROCHLORIDE
erlotinib hydrochloride
TABLET;ORAL091002-003Jun 11, 2014DISCNNoNo► Subscribe► Subscribe► Subscribe
Osi Pharms
TARCEVA
erlotinib hydrochloride
TABLET;ORAL021743-001Nov 18, 2004RXYesNo► Subscribe► Subscribe► Subscribe
Teva Pharms Usa
ERLOTINIB HYDROCHLORIDE
erlotinib hydrochloride
TABLET;ORAL091059-002Aug 28, 2015DISCNNoNo► Subscribe► Subscribe► Subscribe
Osi Pharms
TARCEVA
erlotinib hydrochloride
TABLET;ORAL021743-003Nov 18, 2004RXYesYes► Subscribe► Subscribe ► Subscribe
Osi Pharms
TARCEVA
erlotinib hydrochloride
TABLET;ORAL021743-001Nov 18, 2004RXYesNo► Subscribe► SubscribeY► Subscribe
Osi Pharms
TARCEVA
erlotinib hydrochloride
TABLET;ORAL021743-003Nov 18, 2004RXYesYes► Subscribe► Subscribe► Subscribe
Osi Pharms
TARCEVA
erlotinib hydrochloride
TABLET;ORAL021743-002Nov 18, 2004RXYesNo► Subscribe► SubscribeY► Subscribe
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International Patent Family for Ingredient: erlotinib hydrochloride

Country Document Number Estimated Expiration
Mexico9707453► Subscribe
Israel129994► Subscribe
Israel189037► Subscribe
Slovenia9600102► Subscribe
European Patent Office2163546► Subscribe
Morocco25570► Subscribe
Peru43897► Subscribe
CroatiaP960147► Subscribe
Norway327082► Subscribe
Australia3585499► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: ERLOTINIB HYDROCHLORIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB06/008United Kingdom► SubscribePRODUCT 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
00214Netherlands► SubscribePRODUCT NAME: ERLOTINIB, DESGEWENST IN DE; REGISTRATION NO/DATE: 57266 01,..02,..03EU/1/05/311/001...003 20050321
2006 00006Denmark► Subscribe
C0010France► SubscribePRODUCT NAME: ERLOTINIB HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: EU/1/05/311/001 20050919; FIRST REGISTRATION: LI - 57266 20050321
209Luxembourg► Subscribe91209, EXPIRES: 20200321
0817775/01Switzerland► SubscribeFORMER REPRESENTATIVE: BOHEST AG, CH
C001/2006Ireland► SubscribeSPC001/2006: 20070817, EXPIRES: 20200320
2006Austria► SubscribePRODUCT 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
0214Netherlands► Subscribe300214, 20150606, EXPIRES: 20200320
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Merck
Queensland Health
Argus Health
Teva
Johnson and Johnson
Novartis
Chubb
Healthtrust
Harvard Business School
Moodys

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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