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ENBREL Drug Profile

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Summary for Tradename: ENBREL

Patents:	352
Applicants:	1
BLAs:	1
Suppliers: see list	2
Drug Prices:	Drug price information for ENBREL
Recent Clinical Trials:	See clinical trials for ENBREL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ENBREL

See drug prices for ENBREL

Recent Clinical Trials for ENBREL

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Rochester General Hospital	Phase 1
RTI International	Phase 1
Nova Southeastern University	Phase 1

See all ENBREL clinical trials

Recent Litigation for ENBREL

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
CELGENE CORPORATION v. MYLAN PHARMACEUTICALS INC.	2019-12-31
CELGENE CORPORATION v. HETERO LABS LIMITED	2019-07-16
CELGENE CORPORATION v. DR. REDDY'S LABORATORIES, LTD.	2019-07-12

See all ENBREL litigation

PTAB Litigation

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

See all ENBREL litigation

Pharmacology for ENBREL

Mechanism of Action

Tumor Necrosis Factor Receptor Blocking Activity

Company Disclosures: US Patents for ENBREL

These patents were extracted from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Number	Approval Date	Patent No.	Assignee	Estimated Patent Expiration	Status	Orphan	Source
Immunex	ENBREL	etanercept	VIAL; SUBCUTANEOUS	103795	001	1998-11-02		Immunex Corporation (Seattle, WA)	2012-03-07	RX	Orphan	company
Immunex	ENBREL	etanercept	VIAL; SUBCUTANEOUS	103795	001	1998-11-02		Immunex Corporation (Seattle, WA)	2014-02-25	RX	Orphan	company
Immunex	ENBREL	etanercept	VIAL; SUBCUTANEOUS	103795	001	1998-11-02		Immunex Corporation (Seattle, WA)	2009-09-05	RX	Orphan	company
Immunex	ENBREL	etanercept	VIAL; SUBCUTANEOUS	103795	001	1998-11-02		Immunex Corporation (Seattle, WA)	2009-09-11	RX	Orphan	company

Patent Text Search: US Patents for ENBREL

These patents were identified by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Number	Approval Date	Patent No.	Assignee	Estimated Patent Expiration	Status	Orphan	Source
Immunex	ENBREL	etanercept	VIAL; SUBCUTANEOUS	103795	001	1998-11-02		Massachusetts Eye and Ear Infirmary (Boston, MA)	2034-06-16	RX	Orphan	search
Immunex	ENBREL	etanercept	VIAL; SUBCUTANEOUS	103795	001	1998-11-02		SIO2 MEDICAL PRODUCTS, INC. (Auburn, AL)	2033-03-11	RX	Orphan	search
Immunex	ENBREL	etanercept	VIAL; SUBCUTANEOUS	103795	001	1998-11-02		Knopp Biosciences LLC (Pittsburgh, PA)	2033-08-13	RX	Orphan	search
Immunex	ENBREL	etanercept	VIAL; SUBCUTANEOUS	103795	001	1998-11-02		Coherus Biosciences, Inc. (Redwood City, CA)	2039-02-26	RX	Orphan	search

International Patents for ENBREL

Country	Patent Number	Estimated Expiration
Japan	4881536
Taiwan	201531484
China	104661651
Japan	2019089810

Supplementary Protection Certificates for ENBREL

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2017C/054	Belgium		PRODUCT NAME: KEVZARA - SARILUMAB; AUTHORISATION NUMBER AND DATE: EU/1/17/1196 20170627
CR 2017 00061	Denmark		PRODUCT NAME: SARILUMAB; REG. NO/DATE: EU/1/17/1196/001-8 20170627
LUC00125	Luxembourg		PRODUCT NAME: APREMILAST, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; AUTHORISATION NUMBER AND DATE:
132017000135500	Italy		PRODUCT NAME: SARILUMAB(KEVZARA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1196, 20170627