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
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 |


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
Sponsor | Phase |
---|---|
Fudan University | Phase 2 |
Prostate Cancer Canada | Phase 2 |
Bayer | Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes for FIRMAGON
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 |