Cetuximab - Biologic Drug Details

Summary for cetuximab

Tradenames:	1
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
Taiwan Leader Biotech Corp.	Phase 1/Phase 2
Bhupesh Parashar, MD	Phase 2
Seagen Inc.	Phase 3

See all cetuximab clinical trials

Recent Litigation for cetuximab

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
AbbVie Inc. v. Alvotech hf.	2021-05-28
Alvotech USA Inc. v. Abbvie Inc	2021-05-11
Ravgen, Inc. v. Myriad Genetics, Inc.	2020-12-20

See all cetuximab litigation

PTAB Litigation

Petitioner	Date
Illumina, Inc.	2021-07-20
Laboratory Corporation of America Holdings	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
Eli Lilly And Company	ERBITUX	cetuximab	Injection	125084		2039-02-26	Patent claims search
Eli Lilly And Company	ERBITUX	cetuximab	Injection	125084		2030-04-21	Patent claims search
Eli Lilly And Company	ERBITUX	cetuximab	Injection	125084		2033-09-13	Patent claims search
Eli Lilly And Company	ERBITUX	cetuximab	Injection	125084		2039-02-26	Patent claims search

International Patents for cetuximab

Country	Patent Number	Estimated Expiration
Japan	3600617
Netherlands	300350
Japan	3732426
Luxembourg	91449
Spain	2174859
Australia	4128089
Germany	122008000030

Supplementary Protection Certificates for cetuximab

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
91449	Luxembourg		91449, EXPIRES: 20140915
122004000040	Germany		PRODUCT NAME: CETUXIMAB IN KOMBINATION MIT IRINOTECAN; REGISTRATION NO/DATE: EU/1/04/281/001 20040629
122008000027	Germany		PRODUCT NAME: PANITUMUMAB; REGISTRATION NO/DATE: EU/1/07/423/001-003 20071203
91117	Luxembourg		91117, EXPIRES: 20140915
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
08C0022	France		PRODUCT NAME: PANITUMUMAB; REGISTRATION NO/DATE IN FRANCE: EU/1/07/423/001 DU 20071203; REGISTRATION NO/DATE AT EEC: EU/1/07/423/001 DU 20071203
91116	Luxembourg		91116, EXPIRES: 20140915