Eculizumab - Biologic Drug Details

Summary for eculizumab

Tradenames:	1
Patents:	3
Applicants:	1
BLAs:	1
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for eculizumab
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for eculizumab

Recent Clinical Trials for eculizumab

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
NovelMed Therapeutics	Phase 2
Regeneron Pharmaceuticals	Phase 3
BioCryst Pharmaceuticals	Phase 2

See all eculizumab clinical trials

Recent Litigation for eculizumab

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
AbbVie Inc. v. Alvotech hf.	2021-04-27

See all eculizumab litigation

PTAB Litigation

Petitioner	Date
Amgen Inc.	2019-02-28
Amgen, Inc.	2019-02-28
	2017-12-20

See all eculizumab litigation

Pharmacology for eculizumab

Mechanism of Action	Complement Inhibitors
Established Pharmacologic Class	Complement Inhibitor

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 eculizumab Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Alexion Pharmaceuticals, Inc.	SOLIRIS	eculizumab	Injection	125166		2019-03-12	Company disclosures
Alexion Pharmaceuticals, Inc.	SOLIRIS	eculizumab	Injection	125166		2027-03-15	Company disclosures
Alexion Pharmaceuticals, Inc.	SOLIRIS	eculizumab	Injection	125166		2027-03-15	Company disclosures

3) Low Certainty: US Patents for eculizumab 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
Alexion Pharmaceuticals, Inc.	SOLIRIS	eculizumab	Injection	125166		2032-02-15	Patent claims search
Alexion Pharmaceuticals, Inc.	SOLIRIS	eculizumab	Injection	125166		2034-01-02	Patent claims search
Alexion Pharmaceuticals, Inc.	SOLIRIS	eculizumab	Injection	125166		2029-11-05	Patent claims search
Alexion Pharmaceuticals, Inc.	SOLIRIS	eculizumab	Injection	125166		2033-01-04	Patent claims search
Alexion Pharmaceuticals, Inc.	SOLIRIS	eculizumab	Injection	125166		2039-05-17	Patent claims search
Alexion Pharmaceuticals, Inc.	SOLIRIS	eculizumab	Injection	125166		2026-09-10	Patent claims search
Alexion Pharmaceuticals, Inc.	SOLIRIS	eculizumab	Injection	125166		2033-03-19	Patent claims search

International Patents for eculizumab

Country	Patent Number	Estimated Expiration
South Korea	20080110800
European Patent Office	2522364
Spain	2389093
Slovenia	2359834
Japan	2012095650
South Korea	100442019
Israel	198320

Supplementary Protection Certificates for eculizumab

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
10C0016	France		PRODUCT NAME: ECULIZUMAB; REGISTRATION NO/DATE: EU/1/07/393/001 20070620
CA 2010 00003	Denmark
SZ 12/2010	Austria		PRODUCT NAME: ECULIZUMAB
122009000075	Germany		PRODUCT NAME: ECULIZUMAB; REGISTRATION NO/DATE: EU/1/07/393/001 20070620
SPC/GB10/015	United Kingdom		PRODUCT NAME: ECULIZUMAB; REGISTERED: UK EU/1/07/393/001 20070620
300433	Netherlands		PRODUCT NAME: ECULIZUMAB; REGISTRATION NO/DATE: EU/1/07/393/001 20070620
12/2010	Austria		PRODUCT NAME: ECULIZUMAB; REGISTRATION NO/DATE: EU/1/07/393/001 20070620