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Last Updated: October 25, 2020

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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 patent protection?

Erlotinib hydrochloride is the generic ingredient in two branded drugs marketed by Accord Hlthcare, Apotex, Mylan, Natco Pharma Ltd, Shilpa Medicare Ltd, Sun Pharm, Teva Pharms Usa, Zydus Pharms, and Osi Pharms, and is included in nine NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Erlotinib hydrochloride has fifty-seven patent family members in thirty-eight countries.

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

Recent Clinical Trials for erlotinib hydrochloride

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

SponsorPhase
The First Affiliated Hospital of Guangzhou Medical UniversityPhase 2
LinkDoc Technology (Beijing) Co. Ltd.Phase 4
Tian XiePhase 4

See all erlotinib hydrochloride clinical trials

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

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
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
Teva Pharms Usa ERLOTINIB HYDROCHLORIDE erlotinib hydrochloride TABLET;ORAL 091059-003 Aug 28, 2015 AB RX No No   Start Trial   Start Trial   Start Trial
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 Y   Start Trial
Natco Pharma Ltd ERLOTINIB HYDROCHLORIDE erlotinib hydrochloride TABLET;ORAL 208488-003 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

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 021743-003 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 021743-002 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 06C0010 France   Start Trial PRODUCT NAME: ERLOTINIB HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: EU/1/05/311/001 20050919; FIRST REGISTRATION: LI - 57266 20050321
0817775 5/2006 Austria   Start 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
0817775 SPC/GB06/008 United Kingdom   Start 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
0817775 C300214 Netherlands   Start Trial PRODUCT NAME: ERLOTINIB, DESGEWENST IN DE; REGISTRATION NO/DATE: 57266 01,..02,..03EU/1/05/311/001...003 20050321
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Boehringer Ingelheim
Mallinckrodt
Medtronic
McKesson

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