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Degarelix acetate - Generic Drug Details

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What are the generic sources for degarelix acetate and what is the scope of freedom to operate?

Degarelix acetate is the generic ingredient in one branded drug marketed by Ferring and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Degarelix acetate has one hundred and forty patent family members in thirty-six countries.

One supplier is listed for this compound.

Summary for degarelix acetate

International Patents:	140
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	39
Clinical Trials:	30
Patent Applications:	4,614
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for degarelix acetate
DailyMed Link:	degarelix acetate at DailyMed

Recent Clinical Trials for degarelix acetate

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
City of Hope Medical Center	Phase 2
NRG Oncology	Phase 3
Alliance for Clinical Trials in Oncology	Phase 3

See all degarelix acetate clinical trials

Paragraph IV (Patent) Challenges for DEGARELIX ACETATE

Tradename	Dosage	Ingredient	NDA	Submissiondate
FIRMAGON	POWDER;SUBCUTANEOUS	degarelix acetate	022201	2019-12-20

US Patents and Regulatory Information for degarelix acetate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ferring	FIRMAGON	degarelix acetate	POWDER;SUBCUTANEOUS	022201-001	Dec 24, 2008		RX	Yes	No
Ferring	FIRMAGON	degarelix acetate	POWDER;SUBCUTANEOUS	022201-002	Dec 24, 2008		RX	Yes	Yes
Ferring	FIRMAGON	degarelix acetate	POWDER;SUBCUTANEOUS	022201-002	Dec 24, 2008		RX	Yes	Yes			Y	Y
Ferring	FIRMAGON	degarelix acetate	POWDER;SUBCUTANEOUS	022201-001	Dec 24, 2008		RX	Yes	No
Ferring	FIRMAGON	degarelix acetate	POWDER;SUBCUTANEOUS	022201-001	Dec 24, 2008		RX	Yes	No
Ferring	FIRMAGON	degarelix acetate	POWDER;SUBCUTANEOUS	022201-002	Dec 24, 2008		RX	Yes	Yes
Ferring	FIRMAGON	degarelix acetate	POWDER;SUBCUTANEOUS	022201-001	Dec 24, 2008		RX	Yes	No

International Patents for degarelix acetate

Country	Patent Number	Estimated Expiration
Israel	132303
Eurasian Patent Organization	020543
Mexico	2010008816
Japan	2019218360
China	1230442
Czech Republic	9903586
South Korea	101542480

Supplementary Protection Certificates for degarelix acetate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1003774	SPC020/2009	Ireland		SPC020/2009: 20091119, EXPIRES: 20230412
1003774	09C0028	France		PRODUCT NAME: DEGARELIX, SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, EN PARTICULIER ACETATE; REGISTRATION NO/DATE IN FRANCE: EU/1/08/504/001 DU 20090217; REGISTRATION NO/DATE AT EEC: EU/1/08/504/001 DU 20090217
1003774	122009000033	Germany		PRODUCT NAME: DEGARELIX, GGF. IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES DAVON, WIE DEM ACETAT; REGISTRATION NO/DATE: EU/1/08/504/001-002 20090217
1003774	PA2009005,C1003774	Lithuania		PRODUCT NAME: DEGARELIXUM ACETAT; REGISTRATION NO/DATE: EU/1/08/504/001, 2009 02 17 EU/1/08/504/002 20090217
1003774	91585	Luxembourg		PRODUCT NAME: DEGARELIX, EVENTUELLEMENT UN SEL PHARMACEUTIQUEMENT ACCEPTABE, TEL QUE L'ACETATE (FIRMAGON); REG. DATE: 20090217
1003774	PA2009005	Lithuania		PRODUCT NAME: DEGARELIXUM ACETAT; REGISTRATION NO/DATE: EU/1/08/504/001, 2009 02 17 EU/1/08/504/002 20090217
1003774	SPC/GB09/028	United Kingdom		PRODUCT NAME: DEGARELIX OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT SUCH AS THE ACETATE; REGISTERED: UK EU/1/08/504/001 20090217; UK EU/1/08/504/002 20090217