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Last Updated: March 28, 2024

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, Apotex, Eugia Pharma, MSN, Natco Pharma Ltd, Rising, Shilpa, Sun Pharm, Teva Pharms Usa Inc, Zydus Pharms, and Osi Pharms, and is included in twelve NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-three drug master file entries for erlotinib hydrochloride. Thirteen suppliers are listed for this compound.

Recent Clinical Trials for erlotinib hydrochloride

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

SponsorPhase
MedSIRPhase 2
Asan Medical CenterPhase 2
Boryung Pharmaceutical Co., LtdPhase 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 Strength NDA ANDAs Submitted Submissiondate
TARCEVA Tablets erlotinib hydrochloride 25 mg 021743 1 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 Inc ERLOTINIB HYDROCHLORIDE erlotinib hydrochloride TABLET;ORAL 091059-003 Aug 28, 2015 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sun Pharm ERLOTINIB HYDROCHLORIDE erlotinib hydrochloride TABLET;ORAL 210300-002 Nov 5, 2019 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Teva Pharms Usa Inc ERLOTINIB HYDROCHLORIDE erlotinib hydrochloride TABLET;ORAL 091059-001 Nov 9, 2020 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 ⤷  Try a Trial ⤷  Try a Trial
Osi Pharms TARCEVA erlotinib hydrochloride TABLET;ORAL 021743-001 Nov 18, 2004 ⤷  Try a Trial ⤷  Try a Trial
Osi Pharms TARCEVA erlotinib hydrochloride TABLET;ORAL 021743-003 Nov 18, 2004 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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