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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:	39
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

International Patents for FIRMAGON

Country	Document Number	Estimated Expiration
European Patent Office	1003774
Japan	2011511785
European Patent Office	2249859
Hong Kong	1176552

Supplementary Protection Certificates for FIRMAGON

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2009005,C1003774	Lithuania		PRODUCT NAME: DEGARELIXUM ACETAT; REGISTRATION NO/DATE: EU/1/08/504/001, 2009 02 17 EU/1/08/504/002 20090217
2009 00022	Denmark
C/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
0395	Netherlands		300395, 20180413, EXPIRES: 20230412