Erbitux® (cetuximab)

BL 125084

Erbitux® (cetuximab)

BL 125084

U.S. License Holder:

ImClone

Date of License:

February-12-2004

Last Update:

Dec-15-2024

approved_indications FDA-Approved Indications

ERBITUX (cetuximab) is an epidermal growth factor receptor (EGFR) antagonist indicated for treatment of:

Head and Neck Cancer: Locally or regionally advanced squamous cell carcinoma of the head and neck in combination with radiation therapy; Recurrent locoregional disease or metastatic squamous cell carcinoma of the head and neck in combination with platinum-based therapy with fluorouracil; Recurrent or metastatic squamous cell carcinoma of the head and neck progressing after platinum-based therapy;

Colorectal Cancer K-Ras wild-type, EGFR-expressing, metastatic colorectal cancer as determined by an FDA-approved test: in combination with FOLFIRI for first-line treatment; in combination with irinotecan in patients who are refractory to irinotecan-based chemotherapy; as a single agent in patients who have failed oxaliplatin- and irinotecan-based chemotherapy or who are intolerant to irinotecan;

BRAF V600E Mutation-Positive Metastatic Colorectal Cancer (CRC): In combination with encorafenib, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy.

approved_indications Inter Partes Review Proceedings

PTAB Portal

IPR Case No(s):

IPR2016-00458

U.S. Patent No.
7,625,558 (Compositions and Methods of Treating Tumors)

Patent Owner
The Trustees of the University of Pennsylvania

Petitioner(s)
Eli Lilly and Co.; ImClone Systems LLC; ImClone LLC; Bristol-Myers Squibb Co.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1-7, 9-12, 14, 16, 17, 19-31

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
17-2397

IPR Status
Final Written Decision (All Instituted Claims Found Unpatentable); Federal Circuit Affirmed; Petition for Panel Rehearing and Rehearing En Banc Denied

approved_indications U.S. Patent Litigations

PACER

Case No(s):

2:13-cv-05400 (N.D. Cal.)

U.S. Patent Nos.
6,331,415 (Methods of Producing Immunoglobulins, Vectors and Transformed Host Cells for Use Therein) 7,923,221 (Methods of Making Antibody Heavy and Light Chains having Specificity for a Desired Antigen)

Plaintiffs
Bristol-Myers Squibb Co.

Defendants
City of Hope; Genentech, Inc.

Status
Dismissed

BPCIA
N

2:13-cv-07248 (C.D. Cal.)

U.S. Patent Nos.
6,331,415 (Methods of Producing Immunoglobulins, Vectors and Transformed Host Cells for Use Therein) 7,923,221 (Methods of Making Antibody Heavy and Light Chains having Specificity for a Desired Antigen)

Plaintiffs
Eli Lilly and Co.; ImClone Systems LLC

Defendants
City of Hope; Genentech, Inc.

Status
Dismissed

BPCIA
N

2:15-cv-06133 (E.D. Pa.)

U.S. Patent Nos.
7,625,558 (Compositions and Methods of Treating Tumors)

Plaintiffs
The Trustees of The University of Pennsylvania

Defendants
Bristol-Myers Squibb Co.; Eli Lilly and Co.; ImClone LLC

Status
Voluntarily Dismissed

BPCIA
N

3:13-cv-02045 (N.D. Cal.)

U.S. Patent Nos.
6,331,415 (Methods of Producing Immunoglobulins, Vectors and Transformed Host Cells for Use Therein) 7,923,221 (Methods of Making Antibody Heavy and Light Chains having Specificity for a Desired Antigen)

Plaintiffs
Bristol-Myers Squibb Co.

Defendants
City of Hope; Genentech, Inc.

Status
Transferred and Consolidated with 2:13-cv-05400 (N.D. Cal.); Case Terminated

BPCIA
N

4:13-cv-00919 (N.D. Cal.)

U.S. Patent Nos.
6,331,415 (Methods of Producing Immunoglobulins, Vectors and Transformed Host Cells for Use Therein) 7,923,221 (Methods of Making Antibody Heavy and Light Chains having Specificity for a Desired Antigen)

Plaintiffs
Eli Lilly and Co.; ImClone Systems LLC

Defendants
City of Hope; Genentech, Inc.

Federal Circuit Appeal(s)
13-0164

Status
Case Terminated

BPCIA
N

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Methodology

Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.

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