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Last Updated: October 24, 2021

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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, Alembic Pharms Ltd, Apotex, MSN, Mylan, Natco Pharma Ltd, Shilpa, Sun Pharm, Teva Pharms Usa Inc, Zydus Pharms, and Osi Pharms, and is included in eleven 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. Eleven suppliers are listed for this compound.

Recent Clinical Trials for erlotinib hydrochloride

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

SponsorPhase
Loxo Oncology, Inc.Phase 1
Fondazione per la Medicina PersonalizzataPhase 2
The First Affiliated Hospital of Guangzhou Medical UniversityPhase 2

See all erlotinib hydrochloride clinical trials

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
Apotex ERLOTINIB HYDROCHLORIDE erlotinib hydrochloride TABLET;ORAL 208396-002 Nov 5, 2019 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Shilpa ERLOTINIB HYDROCHLORIDE erlotinib hydrochloride TABLET;ORAL 211960-001 Nov 5, 2019 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Apotex ERLOTINIB HYDROCHLORIDE erlotinib hydrochloride TABLET;ORAL 208396-003 Nov 5, 2019 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Sun Pharm ERLOTINIB HYDROCHLORIDE erlotinib hydrochloride TABLET;ORAL 210300-002 Nov 5, 2019 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever 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 021743-003 Nov 18, 2004 ⤷  Free Forever Trial ⤷  Free Forever Trial
Osi Pharms TARCEVA erlotinib hydrochloride TABLET;ORAL 021743-003 Nov 18, 2004 ⤷  Free Forever Trial ⤷  Free Forever Trial
Osi Pharms TARCEVA erlotinib hydrochloride TABLET;ORAL 021743-001 Nov 18, 2004 ⤷  Free Forever Trial ⤷  Free Forever Trial
Osi Pharms TARCEVA erlotinib hydrochloride TABLET;ORAL 021743-003 Nov 18, 2004 ⤷  Free Forever Trial ⤷  Free Forever 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 SPC/GB06/008 United Kingdom ⤷  Free Forever 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 ⤷  Free Forever Trial PRODUCT NAME: ERLOTINIB, DESGEWENST IN DE; REGISTRATION NO/DATE: 57266 01,..02,..03EU/1/05/311/001...003 20050321
0817775 5/2006 Austria ⤷  Free Forever 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 06C0010 France ⤷  Free Forever 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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Serving leading biopharmaceutical companies globally:

Merck
Moodys
Boehringer Ingelheim
Mallinckrodt
Medtronic
McKesson

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