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Last Updated: May 21, 2022

FIRMAGON Drug Patent 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 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

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Drug patent expirations by year for FIRMAGON
Drug Prices for FIRMAGON

See drug prices for FIRMAGON

DrugPatentWatch® Estimated Generic Entry Opportunity Date for FIRMAGON
Generic Entry Date for FIRMAGON*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
Fudan UniversityPhase 2
Prostate Cancer CanadaPhase 2
BayerPhase 2

See all FIRMAGON clinical trials

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.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of FIRMAGON is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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

Method of treating prostate cancer with GnRH antagonist
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING PROSTATE CANCER

Methods of treating prostate cancer with GnRH antagonist
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ADVANCED PROSTATE CANCER WITH A REDUCED LIKELIHOOD OF CAUSING A GONADOTROPHIN RELEASING HORMONE AGONIST SIDE-EFFECT

Methods of treating prostate cancer with GnRH antagonist
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ADVANCED PROSTATE CANCER WITH A REDUCED LIKELIHOOD OF CAUSING A GONADOTROPHIN RELEASING HORMONE AGONIST SIDE-EFFECT

Method of treating prostate cancer with GnRH antagonist
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING PROSTATE CANCER

Method of treating prostate cancer with GnRH antagonist
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ADVANCED PROSTATE CANCER WITH A REDUCED LIKELIHOOD OF CAUSING A GONADOTROPHIN RELEASING HORMONE AGONIST SIDE-EFFECT

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Ferring FIRMAGON degarelix acetate POWDER;SUBCUTANEOUS 022201-002 Dec 24, 2008 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Ferring FIRMAGON degarelix acetate POWDER;SUBCUTANEOUS 022201-001 Dec 24, 2008 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Ferring FIRMAGON degarelix acetate POWDER;SUBCUTANEOUS 022201-002 Dec 24, 2008 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Ferring FIRMAGON degarelix acetate POWDER;SUBCUTANEOUS 022201-001 Dec 24, 2008 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 FIRMAGON

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

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

Patent: 09213748
Estimated Expiration: See Plans and Pricing

Patent: 09213751
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0908127
Estimated Expiration: See Plans and Pricing

Patent: 0908129
Estimated Expiration: See Plans and Pricing

Canada

Patent: 14444
Estimated Expiration: See Plans and Pricing

Patent: 14445
Estimated Expiration: See Plans and Pricing

China

Patent: 1939020
Estimated Expiration: See Plans and Pricing

Patent: 1998861
Estimated Expiration: See Plans and Pricing

Patent: 3990107
Estimated Expiration: See Plans and Pricing

Patent: 7412726
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0140665
Estimated Expiration: See Plans and Pricing

Patent: 0150290
Estimated Expiration: See Plans and Pricing

Patent: 0150633
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 15561
Estimated Expiration: See Plans and Pricing

Patent: 16289
Estimated Expiration: See Plans and Pricing

Patent: 16341
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 49859
Estimated Expiration: See Plans and Pricing

Patent: 05204
Estimated Expiration: See Plans and Pricing

Patent: 50012
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 7582
Estimated Expiration: See Plans and Pricing

Patent: 0543
Estimated Expiration: See Plans and Pricing

Patent: 6521
Estimated Expiration: See Plans and Pricing

Patent: 6695
Estimated Expiration: See Plans and Pricing

Patent: 0901074
Estimated Expiration: See Plans and Pricing

Patent: 0901075
Estimated Expiration: See Plans and Pricing

Patent: 1300741
Estimated Expiration: See Plans and Pricing

Patent: 1300742
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 49858
Estimated Expiration: See Plans and Pricing

Patent: 49859
Estimated Expiration: See Plans and Pricing

Patent: 05204
Estimated Expiration: See Plans and Pricing

Patent: 50012
Estimated Expiration: See Plans and Pricing

Patent: 99085
Estimated Expiration: See Plans and Pricing

Patent: 60565
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 45011
Estimated Expiration: See Plans and Pricing

Patent: 76552
Estimated Expiration: See Plans and Pricing

Patent: 90912
Estimated Expiration: See Plans and Pricing

Patent: 98243
Estimated Expiration: See Plans and Pricing

Patent: 58957
Estimated Expiration: See Plans and Pricing

Israel

Patent: 7295
Estimated Expiration: See Plans and Pricing

Patent: 7400
Estimated Expiration: See Plans and Pricing

Patent: 3124
Estimated Expiration: See Plans and Pricing

Japan

Patent: 76652
Estimated Expiration: See Plans and Pricing

Patent: 24866
Estimated Expiration: See Plans and Pricing

Patent: 89234
Estimated Expiration: See Plans and Pricing

Patent: 54042
Estimated Expiration: See Plans and Pricing

Patent: 18967
Estimated Expiration: See Plans and Pricing

Patent: 11511785
Estimated Expiration: See Plans and Pricing

Patent: 11511786
Estimated Expiration: See Plans and Pricing

Patent: 14141505
Estimated Expiration: See Plans and Pricing

Patent: 14167009
Estimated Expiration: See Plans and Pricing

Patent: 16193910
Estimated Expiration: See Plans and Pricing

Patent: 16216455
Estimated Expiration: See Plans and Pricing

Patent: 18039814
Estimated Expiration: See Plans and Pricing

Patent: 19059726
Estimated Expiration: See Plans and Pricing

Patent: 19218360
Estimated Expiration: See Plans and Pricing

Patent: 20196722
Estimated Expiration: See Plans and Pricing

Jordan

Patent: 25
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 10008816
Estimated Expiration: See Plans and Pricing

Patent: 10008817
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 7057
Estimated Expiration: See Plans and Pricing

Patent: 7088
Estimated Expiration: See Plans and Pricing

Patent: 3932
Estimated Expiration: See Plans and Pricing

Patent: 3958
Estimated Expiration: See Plans and Pricing

Poland

Patent: 49859
Estimated Expiration: See Plans and Pricing

Patent: 05204
Estimated Expiration: See Plans and Pricing

Patent: 50012
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 49859
Estimated Expiration: See Plans and Pricing

Patent: 05204
Estimated Expiration: See Plans and Pricing

Patent: 50012
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 04393
Estimated Expiration: See Plans and Pricing

Patent: 04394
Estimated Expiration: See Plans and Pricing

Patent: 10133480
Estimated Expiration: See Plans and Pricing

Patent: 10133481
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 49859
Estimated Expiration: See Plans and Pricing

Patent: 05204
Estimated Expiration: See Plans and Pricing

Patent: 50012
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1005697
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1542480
Estimated Expiration: See Plans and Pricing

Patent: 100123714
Estimated Expiration: See Plans and Pricing

Patent: 100126362
Estimated Expiration: See Plans and Pricing

Patent: 140130757
Estimated Expiration: See Plans and Pricing

Patent: 150091543
Estimated Expiration: See Plans and Pricing

Patent: 180118830
Estimated Expiration: See Plans and Pricing

Patent: 200001623
Estimated Expiration: See Plans and Pricing

Patent: 210005323
Estimated Expiration: See Plans and Pricing

Patent: 220009504
Estimated Expiration: See Plans and Pricing

Spain

Patent: 79441
Estimated Expiration: See Plans and Pricing

Patent: 32709
Estimated Expiration: See Plans and Pricing

Patent: 40235
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 42932
Estimated Expiration: See Plans and Pricing

Patent: 39959
Estimated Expiration: See Plans and Pricing

Patent: 0938217
Estimated Expiration: See Plans and Pricing

Patent: 0938218
Estimated Expiration: See Plans and Pricing

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 See Plans and Pricing
South Korea 20220009504 데가렐릭스를 이용한 전이 단계의 전립선암의 치료 방법 (TREATMENT OF METASTATIC STAGE PROSTATE CANCER WITH DEGARELIX) See Plans and Pricing
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) See Plans and Pricing
Eurasian Patent Organization 200901075 СПОСОБ ЛЕЧЕНИЯ РАКА ПРЕДСТАТЕЛЬНОЙ ЖЕЛЕЗЫ АНТАГОНИСТОМ ГОНАДОТРОПИН-ВЫСВОБОЖДАЮЩЕГО ГОРМОНА (GnRH) ДЕГАРЕЛИКСОМ See Plans and Pricing
Hungary 0002704 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for FIRMAGON

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1003774 PA2009005 Lithuania See Plans and Pricing 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 See Plans and Pricing
1003774 SPC020/2009 Ireland See Plans and Pricing SPC020/2009: 20091119, EXPIRES: 20230412
1003774 PA2009005,C1003774 Lithuania See Plans and Pricing PRODUCT NAME: DEGARELIXUM ACETAT; REGISTRATION NO/DATE: EU/1/08/504/001, 2009 02 17 EU/1/08/504/002 20090217
1003774 09C0028 France See Plans and Pricing 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.