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Last Updated: March 28, 2024

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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 seven patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and four 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 four 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 Loss of Exclusivity (LOE) 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
BayerPhase 1/Phase 2
Praful RaviPhase 1/Phase 2
Eli Lilly and CompanyPhase 1/Phase 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 seven US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of FIRMAGON is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING PROSTATE CANCER

Methods of treating prostate cancer with GnRH antagonist
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ADVANCED PROSTATE CANCER WITH A REDUCED LIKELIHOOD OF CAUSING A GONADOTROPHIN RELEASING HORMONE AGONIST SIDE-EFFECT


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ADVANCED PROSTATE CANCER WITH A REDUCED LIKELIHOOD OF CAUSING A GONADOTROPHIN RELEASING HORMONE AGONIST SIDE-EFFECT


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING PROSTATE CANCER

Method of treating prostate cancer with GnRH antagonist
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Ferring FIRMAGON degarelix acetate POWDER;SUBCUTANEOUS 022201-001 Dec 24, 2008 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Ferring FIRMAGON degarelix acetate POWDER;SUBCUTANEOUS 022201-001 Dec 24, 2008 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity 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: ⤷  Try a Trial

Patent: 09213751
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 0908127
Estimated Expiration: ⤷  Try a Trial

Patent: 0908129
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 14444
Estimated Expiration: ⤷  Try a Trial

Patent: 14445
Estimated Expiration: ⤷  Try a Trial

China

Patent: 1939020
Estimated Expiration: ⤷  Try a Trial

Patent: 1998861
Estimated Expiration: ⤷  Try a Trial

Patent: 3990107
Estimated Expiration: ⤷  Try a Trial

Patent: 7412726
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0140665
Estimated Expiration: ⤷  Try a Trial

Patent: 0150290
Estimated Expiration: ⤷  Try a Trial

Patent: 0150633
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 15561
Estimated Expiration: ⤷  Try a Trial

Patent: 16289
Estimated Expiration: ⤷  Try a Trial

Patent: 16341
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 49859
Estimated Expiration: ⤷  Try a Trial

Patent: 05204
Estimated Expiration: ⤷  Try a Trial

Patent: 50012
Estimated Expiration: ⤷  Try a Trial

Eurasian Patent Organization

Patent: 7582
Estimated Expiration: ⤷  Try a Trial

Patent: 0543
Estimated Expiration: ⤷  Try a Trial

Patent: 6521
Estimated Expiration: ⤷  Try a Trial

Patent: 6695
Estimated Expiration: ⤷  Try a Trial

Patent: 0901074
Estimated Expiration: ⤷  Try a Trial

Patent: 0901075
Estimated Expiration: ⤷  Try a Trial

Patent: 1300741
Estimated Expiration: ⤷  Try a Trial

Patent: 1300742
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 49858
Estimated Expiration: ⤷  Try a Trial

Patent: 49859
Estimated Expiration: ⤷  Try a Trial

Patent: 05204
Estimated Expiration: ⤷  Try a Trial

Patent: 50012
Estimated Expiration: ⤷  Try a Trial

Patent: 99085
Estimated Expiration: ⤷  Try a Trial

Patent: 60565
Estimated Expiration: ⤷  Try a Trial

Patent: 57197
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 45011
Estimated Expiration: ⤷  Try a Trial

Patent: 76552
Estimated Expiration: ⤷  Try a Trial

Patent: 90912
Estimated Expiration: ⤷  Try a Trial

Patent: 98243
Estimated Expiration: ⤷  Try a Trial

Patent: 58957
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 7295
Estimated Expiration: ⤷  Try a Trial

Patent: 7400
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 76652
Estimated Expiration: ⤷  Try a Trial

Patent: 24866
Estimated Expiration: ⤷  Try a Trial

Patent: 89234
Estimated Expiration: ⤷  Try a Trial

Patent: 54042
Estimated Expiration: ⤷  Try a Trial

Patent: 18967
Estimated Expiration: ⤷  Try a Trial

Patent: 04003
Estimated Expiration: ⤷  Try a Trial

Patent: 18849
Estimated Expiration: ⤷  Try a Trial

Patent: 86748
Estimated Expiration: ⤷  Try a Trial

Patent: 00029
Estimated Expiration: ⤷  Try a Trial

Patent: 11511785
Estimated Expiration: ⤷  Try a Trial

Patent: 11511786
Estimated Expiration: ⤷  Try a Trial

Patent: 14141505
Estimated Expiration: ⤷  Try a Trial

Patent: 14167009
Estimated Expiration: ⤷  Try a Trial

Patent: 16193910
Estimated Expiration: ⤷  Try a Trial

Patent: 16216455
Estimated Expiration: ⤷  Try a Trial

Patent: 18039814
Estimated Expiration: ⤷  Try a Trial

Patent: 19059726
Estimated Expiration: ⤷  Try a Trial

Patent: 19218360
Estimated Expiration: ⤷  Try a Trial

Patent: 20196722
Estimated Expiration: ⤷  Try a Trial

Patent: 22133426
Estimated Expiration: ⤷  Try a Trial

Patent: 22184898
Estimated Expiration: ⤷  Try a Trial

Jordan

Patent: 0090061
Estimated Expiration: ⤷  Try a Trial

Patent: 25
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 10008816
Estimated Expiration: ⤷  Try a Trial

Patent: 10008817
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 7057
Estimated Expiration: ⤷  Try a Trial

Patent: 7088
Estimated Expiration: ⤷  Try a Trial

Patent: 3932
Estimated Expiration: ⤷  Try a Trial

Patent: 3958
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 49859
Estimated Expiration: ⤷  Try a Trial

Patent: 05204
Estimated Expiration: ⤷  Try a Trial

Patent: 50012
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 49859
Estimated Expiration: ⤷  Try a Trial

Patent: 05204
Estimated Expiration: ⤷  Try a Trial

Patent: 50012
Estimated Expiration: ⤷  Try a Trial

Russian Federation

Patent: 04393
Estimated Expiration: ⤷  Try a Trial

Patent: 04394
Estimated Expiration: ⤷  Try a Trial

Patent: 10133480
Estimated Expiration: ⤷  Try a Trial

Patent: 10133481
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 49859
Estimated Expiration: ⤷  Try a Trial

Patent: 05204
Estimated Expiration: ⤷  Try a Trial

Patent: 50012
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 1005697
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1542480
Estimated Expiration: ⤷  Try a Trial

Patent: 100123714
Estimated Expiration: ⤷  Try a Trial

Patent: 100126362
Estimated Expiration: ⤷  Try a Trial

Patent: 140130757
Estimated Expiration: ⤷  Try a Trial

Patent: 150091543
Estimated Expiration: ⤷  Try a Trial

Patent: 180118830
Estimated Expiration: ⤷  Try a Trial

Patent: 200001623
Estimated Expiration: ⤷  Try a Trial

Patent: 210005323
Estimated Expiration: ⤷  Try a Trial

Patent: 220009504
Estimated Expiration: ⤷  Try a Trial

Patent: 230088848
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 79441
Estimated Expiration: ⤷  Try a Trial

Patent: 32709
Estimated Expiration: ⤷  Try a Trial

Patent: 40235
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 42932
Estimated Expiration: ⤷  Try a Trial

Patent: 39959
Estimated Expiration: ⤷  Try a Trial

Patent: 0938217
Estimated Expiration: ⤷  Try a Trial

Patent: 0938218
Estimated Expiration: ⤷  Try a Trial

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
Poland 2505204 ⤷  Try a Trial
Denmark 1003774 ⤷  Try a Trial
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) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for FIRMAGON

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1003774 09C0028 France ⤷  Try a Trial 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 Lithuania ⤷  Try a Trial PRODUCT NAME: DEGARELIXUM ACETAT; REGISTRATION NO/DATE: EU/1/08/504/001, 2009 02 17 EU/1/08/504/002 20090217
1003774 91585 Luxembourg ⤷  Try a Trial 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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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.