FIRMAGON Drug Patent Profile

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 five patents protecting this drug and one Paragraph IV challenge.

This drug has ninety-five patent family members in twenty-four countries.

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.

DrugPatentWatch^® Generic Entry Outlook for Firmagon

Firmagon was eligible for patent challenges on December 24, 2012.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 10, 2029. This may change due to patent challenges or generic licensing.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for FIRMAGON

International Patents:	95
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	34
Clinical Trials:	56
Patent Applications:	2,531
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for FIRMAGON
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FIRMAGON
What excipients (inactive ingredients) are in FIRMAGON?	FIRMAGON excipients list
DailyMed Link:	FIRMAGON at DailyMed

See drug prices for FIRMAGON

DrugPatentWatch^® Estimated 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.

Recent Clinical Trials for FIRMAGON

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

Sponsor	Phase
Fudan University	Phase 2
Prostate Cancer Canada	Phase 2
Bayer	Phase 2

See all FIRMAGON clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for FIRMAGON

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 FIRMAGON

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 FIRMAGON

FIRMAGON is protected by five US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting 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
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
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

Expired US Patents for FIRMAGON

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

International Patents for FIRMAGON

When does loss-of-exclusivity occur for FIRMAGON?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

Hong Kong

Israel

Japan

Jordan

Mexico

New Zealand

Poland

Portugal

Russian Federation

Slovenia

South Africa

South Korea

Spain

Taiwan

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering FIRMAGON around the world.

Country	Patent Number	Title	Estimated Expiration
South Africa	9803062
South Korea	20220009504	데가렐릭스를 이용한 전이 단계의 전립선암의 치료 방법 (TREATMENT OF METASTATIC STAGE PROSTATE CANCER WITH DEGARELIX)
European Patent Office	2249858	PROCÉDÉ DE TRAITEMENT DU CANCER DE LA PROSTATE PAR LE DEGARELIX, ANTAGONISTE DE GNRH (METHOD OF TREATING PROSTATE CANCER WITH THE GNRH ANTAGONIST DEGARELIX)
Eurasian Patent Organization	200901075	СПОСОБ ЛЕЧЕНИЯ РАКА ПРЕДСТАТЕЛЬНОЙ ЖЕЛЕЗЫ АНТАГОНИСТОМ ГОНАДОТРОПИН-ВЫСВОБОЖДАЮЩЕГО ГОРМОНА (GnRH) ДЕГАРЕЛИКСОМ
Hungary	0002704

Supplementary Protection Certificates for FIRMAGON

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	CA 2009 00022	Denmark
1003774	SPC020/2009	Ireland		SPC020/2009: 20091119, EXPIRES: 20230412
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	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