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

Degarelix acetate has one hundred and five patent family members in twenty-four countries.

One supplier is listed for this compound.

Summary for degarelix acetate

International Patents:	105
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	21
Clinical Trials:	36
Patent Applications:	120
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for degarelix acetate
DailyMed Link:	degarelix acetate at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for degarelix acetate

Generic Entry Date for degarelix acetate^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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.

Recent Clinical Trials for degarelix acetate

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

Sponsor	Phase
Fudan University	Phase 2
Alliance for Clinical Trials in Oncology	Phase 3
Myovant Sciences GmbH	Phase 1

See all degarelix acetate clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for degarelix acetate

L02BX	Other hormone antagonists and related agents
L02B	HORMONE ANTAGONISTS AND RELATED AGENTS
L02	ENDOCRINE THERAPY
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for DEGARELIX ACETATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
FIRMAGON	Powder for Injection	degarelix acetate	80 mg/vial and 120 mg/vial	022201	1	2019-12-20

US Patents and Regulatory Information for degarelix acetate

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Glossary

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

Expired US Patents for degarelix acetate

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ferring	FIRMAGON	degarelix acetate	POWDER;SUBCUTANEOUS	022201-001	Dec 24, 2008	⤷ Sign Up	⤷ Sign Up
Ferring	FIRMAGON	degarelix acetate	POWDER;SUBCUTANEOUS	022201-002	Dec 24, 2008	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for degarelix acetate

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Country	Patent Number	Title	Estimated Expiration
New Zealand	587057	METHOD OF TREATING PROSTATE CANCER WITH THE GNRH ANTAGONIST DEGARELIX	⤷ Sign Up
China	101939020		⤷ Sign Up
Canada	3235099	PROCEDE DE TRAITEMENT DU CANCER DE LA PROSTATE PAR LE DEGARELIX, ANTAGONISTE DE GNRH (METHOD OF TREATING PROSTATE CANCER WITH THE GNRH ANTAGONIST DEGARELIX)	⤷ Sign Up
South Korea	20200001623		⤷ Sign Up
South Korea	20210005323		⤷ Sign Up
Japan	2020196722		⤷ Sign Up
Cyprus	1115561		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for degarelix acetate

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1003774	09C0028	France	⤷ Sign Up	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	PA2009005,C1003774	Lithuania	⤷ Sign Up	PRODUCT NAME: DEGARELIXUM ACETAT; REGISTRATION NO/DATE: EU/1/08/504/001, 2009 02 17 EU/1/08/504/002 20090217
1003774	122009000033	Germany	⤷ Sign Up	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	SPC/GB09/028	United Kingdom	⤷ Sign Up	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
1003774	C01003774/01	Switzerland	⤷ Sign Up	PRODUCT NAME: DEGARELIX; REGISTRATION NUMBER/DATE: SWISSMEDIC 59455 12.02.2010
1003774	PA2009005	Lithuania	⤷ Sign Up	PRODUCT NAME: DEGARELIXUM ACETAT; REGISTRATION NO/DATE: EU/1/08/504/001, 2009 02 17 EU/1/08/504/002 20090217
1003774	91585	Luxembourg	⤷ Sign Up	PRODUCT NAME: DEGARELIX, EVENTUELLEMENT UN SEL PHARMACEUTIQUEMENT ACCEPTABE, TEL QUE L'ACETATE (FIRMAGON); REG. DATE: 20090217
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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