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FIRMAGON Drug Profile

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Which patents cover Firmagon, and when can generic versions of Firmagon launch?

Firmagon is a drug marketed by Ferring and is included in one NDA. There are three patents protecting this drug.

The generic ingredient in FIRMAGON is degarelix acetate. One supplier is listed for this compound. Additional details are available on the degarelix acetate profile page.

Summary for FIRMAGON

US Patents:	3
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	23
Clinical Trials:	38
Patent Applications:	8
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for FIRMAGON
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FIRMAGON
DailyMed Link:	FIRMAGON at DailyMed

Generic Entry Opportunity Date for FIRMAGON

NDA:

022201

Dosage:

POWDER;SUBCUTANEOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Synonyms for FIRMAGON

214766-78-6

766D786

934016-19-0

934246-14-7

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

AKOS030526717

AN-5181

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-leucy

D01WYT

D08635

D08901

D09400

D0Y7KH

DB06699

Degarelix

Degarelix (INN/USAN)

Degarelix [USAN:INN:BAN]

Degarelix acetate

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 (TN)

Gonax

GTPL5585

HSDB 7817

HY-16168A

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-m

QC-10170

RL02641

SCHEMBL1397034

SX0XJI3A11

Uglypeptide1

UNII-EXT215F4ZU

UNII-SX0XJI3A11

Z-3147

US Patents and Regulatory Information for FIRMAGON

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			Y	Y
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

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Non-Orange Book US Patents for FIRMAGON

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
6,214,798	GnRH antagonists being modified in positions 5 and 6
9,877,999	Methods for treating metastatic stage prostate cancer
8,841,081	Method of treating metastatic stage prostate cancer

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International Patents for FIRMAGON

Country	Document Number	Estimated Expiration
European Patent Office	2249858
South Korea	20100126362
South Korea	20150091543
Hong Kong	1190912
European Patent Office	2799085

Supplementary Protection Certificates for FIRMAGON

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1003774/01	Switzerland		PRODUCT NAME: DEGARELIX; REGISTRATION NUMBER/DATE: SWISSMEDIC 59455 12.02.2010
2009000033	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
0395	Netherlands		300395, 20180413, EXPIRES: 20230412
585	Luxembourg		PRODUCT NAME: DEGARELIX, EVENTUELLEMENT UN SEL PHARMACEUTIQUEMENT ACCEPTABE, TEL QUE L'ACETATE (FIRMAGON); REG. DATE: 20090217
C020/2009	Ireland		SPC020/2009: 20091119, EXPIRES: 20230412