Etanercept - Biologic Drug Details

Summary for etanercept

Tradenames:	2
Patents:	8
Applicants:	3
BLAs:	3
Suppliers: see list	2
Recent Clinical Trials:	See clinical trials for etanercept
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for etanercept

Recent Clinical Trials for etanercept

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	Phase 1
Duke University	Phase 1
McGill University Health Centre/Research Institute of the McGill University Health Centre	N/A

See all etanercept clinical trials

Recent Litigation for etanercept

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
Pharmacyclics LLC v. Alvogen Pine Brook, LLC	2020-03-20
Celgene Corporation v. Mylan Pharmaceuticals Inc.	2020-01-02
CELGENE CORPORATION v. MYLAN PHARMACEUTICALS INC.	2019-12-30

See all etanercept litigation

PTAB Litigation

Petitioner	Date
Dr. Reddy's Laboratories, Inc.	2018-08-03
	2014-11-06
	2013-08-15

See all etanercept litigation

Pharmacology for etanercept

Mechanism of Action	Tumor Necrosis Factor Receptor Blocking Activity
Established Pharmacologic Class	Tumor Necrosis Factor Blocker

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 etanercept Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Immunex Corporation	ENBREL	etanercept	For Injection	103795		2012-03-07	Company disclosures
Immunex Corporation	ENBREL	etanercept	For Injection	103795		2014-02-25	Company disclosures
Immunex Corporation	ENBREL	etanercept	For Injection	103795		2009-09-05	Company disclosures
Immunex Corporation	ENBREL	etanercept	For Injection	103795		2009-09-11	Company disclosures
Immunex Corporation	ENBREL	etanercept	For Injection	103795		2009-09-05	Company disclosures
Immunex Corporation	ENBREL	etanercept	For Injection	103795		2009-09-05	Company disclosures
Immunex Corporation	ENBREL	etanercept	For Injection	103795		2019-04-19	Company disclosures

3) Low Certainty: US Patents for etanercept 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
Immunex Corporation	ENBREL	etanercept	For Injection	103795		2034-06-16	Patent claims search
Immunex Corporation	ENBREL	etanercept	For Injection	103795		2033-03-11	Patent claims search
Immunex Corporation	ENBREL	etanercept	For Injection	103795		2033-08-13	Patent claims search
Immunex Corporation	ENBREL	etanercept	For Injection	103795		2039-02-26	Patent claims search
Immunex Corporation	ENBREL	etanercept	For Injection	103795		2032-10-26	Patent claims search
Immunex Corporation	ENBREL	etanercept	For Injection	103795		2032-07-26	Patent claims search
Immunex Corporation	ENBREL	etanercept	For Injection	103795		2031-05-10	Patent claims search

International Patents for etanercept

Country	Patent Number	Estimated Expiration
Canada	2133326
Australia	4533601
Australia	6178190
European Patent Office	1171148
Australia	6178190
Finland	116943
New Zealand	235148

Supplementary Protection Certificates for etanercept

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0090011-8, 0091011-7	Sweden		NATIONAL REGISTRATION NO/DATE: EU/1/99/126/001 20000203; FIRST REGISTRATION: LI 55365 20000201
C300008	Netherlands		PRODUCT: ETANERCEPTUM
15/2000	Austria		PRODUCT NAME: ETANERCEPT; NAT. REGISTRATION NO/DATE: EU/1/99/126/001 20000203; FIRST REGISTRATION: LI 55365 20000201
00C0015	France		PRODUCT NAME: ETANERCEPT; NAT. REGISTRATION NO/DATE: EU/1/99/126/001 20000203; FIRST REGISTRATION: LI - IKS- N 55365 20000201
SZ 15/2000	Austria		PRODUCT NAME: ETANERCEPT
10075011	Germany		PRODUCT NAME: ENBREL-ETANERCEPT; NAT. REGISTRATION NO/DATE: EU/1/99/126/001 20000203; FIRST REGISTRATION: CH (LI) 55365 20000201
SPC/GB00/015	United Kingdom		PRODUCT NAME: ETANERCEPT; REGISTERED: CH 55365 20000201; UK EU/1/99/126/001 20000203