Time limited offer for new users ▶ Get up to 3 months free

Serving leading biopharmaceutical companies globally:

McKinsey
Colorcon
Harvard Business School
Mallinckrodt
Merck
Moodys

Last Updated: January 30, 2023

Erlotinib hydrochloride - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions


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, 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. Twelve suppliers are listed for this compound.

Recent Clinical Trials for erlotinib hydrochloride

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

SponsorPhase
OBI Pharma, IncPhase 2
Sir Salimullah Medical College Mitford HospitalN/A
AIO-Studien-gGmbHPhase 2

See all erlotinib hydrochloride clinical trials

Pharmacology for erlotinib hydrochloride
Drug ClassKinase Inhibitor
Mechanism of Action Protein 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
Natco Pharma Ltd ERLOTINIB HYDROCHLORIDE erlotinib hydrochloride TABLET;ORAL 208488-003 Nov 5, 2019 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sun Pharm ERLOTINIB HYDROCHLORIDE erlotinib hydrochloride TABLET;ORAL 210300-002 Nov 5, 2019 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Msn ERLOTINIB HYDROCHLORIDE erlotinib hydrochloride TABLET;ORAL 214366-001 May 10, 2021 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 021743-002 Nov 18, 2004 See Plans and Pricing See Plans and Pricing
Osi Pharms TARCEVA erlotinib hydrochloride TABLET;ORAL 021743-001 Nov 18, 2004 See Plans and Pricing See Plans and Pricing
Osi Pharms TARCEVA erlotinib hydrochloride TABLET;ORAL 021743-003 Nov 18, 2004 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Merck
Moodys
Boehringer Ingelheim
Mallinckrodt
Medtronic
McKesson

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 verification 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.