Cetuximab - Biologic Drug Details

Summary for cetuximab

Tradenames:	1
High Confidence Patents:	1
Applicants:	1
BLAs:	1
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for cetuximab
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for cetuximab

Recent Clinical Trials for cetuximab

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
ECOG-ACRIN Cancer Research Group	Phase 3
Mirati Therapeutics	Phase 1
Hummingbird Bioscience	Phase 1/Phase 2

See all cetuximab clinical trials

Recent Litigation for cetuximab

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
Janssen Biotech, Inc. v. Amgen Inc.	2022-11-29
Ravgen, Inc. v. Quest Diagnostics Incorporated	2021-11-17
TwinStrand Biosciences, Inc. v. Guardant Health, Inc.	2021-08-03

See all cetuximab litigation

PTAB Litigation

Petitioner	Date
Illumina, Inc. et al.	2021-07-20
Laboratory Corporation of America Holdings et al.	2021-05-28
Quest Diagnostics Incorporated	2021-04-15

See all cetuximab litigation

Pharmacology for cetuximab

Mechanism of Action	HER1 Antagonists
Established Pharmacologic Class	Epidermal Growth Factor Receptor Antagonist

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. General brand-side disclosures

These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for cetuximab Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for cetuximab Derived from Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Eli Lilly And Company	ERBITUX	cetuximab	Injection	125084		2018-04-17	Company disclosures

3) Low Certainty: US Patents for cetuximab Derived from Patent Text Search

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Eli Lilly And Company	ERBITUX	cetuximab	Injection	125084		2032-09-12	Patent claims search
Eli Lilly And Company	ERBITUX	cetuximab	Injection	125084		2034-09-08	Patent claims search
Eli Lilly And Company	ERBITUX	cetuximab	Injection	125084		2033-03-11	Patent claims search

International Patents for cetuximab

Country	Patent Number	Estimated Expiration
Japan	2002114710
Germany	122008000028
Netherlands	300166

Supplementary Protection Certificates for cetuximab

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
122008000030	Germany		PRODUCT NAME: PANITUMUMAB MIT WENIGSTENS EINEM WIRKSTOFF AUSGEWAEHLT AUS IRINOTECAN, CISPLATIN, 5-FLUOROURACIL, GEMCITABIN, PACLITAXEL UND CARBOPLATIN; REGISTRATION NO/DATE: EU/1/07/423/001-003 20071203
122008000027	Germany		PRODUCT NAME: PANITUMUMAB; REGISTRATION NO/DATE: EU/1/07/423/001-003 20071203
91448	Luxembourg		91448, EXPIRES: 20140915