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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 three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

One supplier is listed for this compound.

Summary for degarelix acetate

International Patents:	136
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	34
Clinical Trials:	26
Patent Applications:	12
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
Eulji University Hospital	Phase 4
Wonju Severance Christian Hospital	Phase 4
Bristol-Myers Squibb	Phase 2

See all degarelix acetate clinical trials

Recent Litigation for degarelix acetate

Identify potential future generic entrants

District Court Litigation

Case Name	Date
Salk Institute for Biological Studies v. Ferring Pharmaceuticals, Inc	2010-12-22

See all degarelix acetate litigation

Synonyms for degarelix acetate

214766-78-6

766D786

934016-19-0

934246-14-7

A12840

Ac-D-Nal-[D-(pCl)Phe]-D-Pal-Ser-[Aph(DHor)]-D-[Aph(Cbm)]-Leu-ILys-Pro-DAla-NH2

Acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide

ASP-3550

ASP3550

BDBM50102450

CHEBI:135961

CHEMBL2028987

CHEMBL415606

CS-5350

D-Alaninamide, N-acetyl-3-(naphtalen-2-yl)-D-alanyl-4-chloro-D-phenylalanyl-3-(pyridin-3-yl)-D-alanyl-L-seryl-4-((((4S)-2,6-dioxohexahydropyrimidin-4-yl)carbonyl)amino)-L-phenylalanyl-4-(carbamoylamino)-D-phenylalanyl-L-leuc

D08635

D08901

D09400

DB06699

Degarelix

Degarelix (acetate) pound>>FE 200486

Degarelix (INN/USAN)

Degarelix [USAN:INN:BAN]

Degarelix acetate (JAN)

Degarelix acetate (USAN)

Degarelix acetate hydrate

Degarelix monoacetate

EXT215F4ZU

FE 200486

FE-200486

FE-200486 (free base)

FE200486

FE200486 (AS ACETATE SALT)

Firmagon

Firmagon (TN)

Gonax

GTPL5585

HSDB 7817

HY-16168A

N-acetyl-3-(2-naphthalenyl)-D-alanyl-4-chloro-D-phenylalanyl-3-(3-pyridinyl)-D-alanyl-L-seryl-4-[[[(4S)-hexahydro-2,6-dioxo-4-pyrimidinyl]carbonyl]amino]-L-phenylalanyl-4-[(aminocarbonyl)amino]-D-phenylalanyl-L-leucyl-N6-(1-

N-Acetyl-3-(naphtalen-2-yl)-D-alanyl-4-chloro-D-phenylalanyl-3-(pyridin-3-yl)-D-alanyl-L-seryl-4-((((4S)-2,6-dioxohexahydropyrimidin-4-yl)carbonyl)amino)-L-phenylalanyl-4-(carbamoylamino)-D-phenylalanyl-L-leucyl-N(sup 6)-(1-

Q1182795

Q27277419

QC-10170

SCHEMBL1397034

SCHEMBL21050504

SX0XJI3A11

Uglypeptide1

UNII-EXT215F4ZU

UNII-SX0XJI3A11

Z-3147

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	022201-002	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			Y	Y
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
New Zealand	587057
European Patent Office	3360565
Czech Republic	9903586
European Patent Office	2650012
Poland	336213
Japan	2016193910

Supplementary Protection Certificates for degarelix acetate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1003774	C01003774/01	Switzerland		PRODUCT NAME: DEGARELIX; REGISTRATION NUMBER/DATE: SWISSMEDIC 59455 12.02.2010
1003774	362	Finland
1003774	SPC020/2009	Ireland		SPC020/2009: 20091119, EXPIRES: 20230412
1003774	300395	Netherlands		300395, 20180413, EXPIRES: 20230412
1003774	CA 2009 00022	Denmark
1003774	PA2009005	Lithuania		PRODUCT NAME: DEGARELIXUM ACETAT; REGISTRATION NO/DATE: EU/1/08/504/001, 2009 02 17 EU/1/08/504/002 20090217