FIRMAGON Drug Patent Profile
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Which patents cover Firmagon, and what generic alternatives are available?
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 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 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
Summary for FIRMAGON
| International Patents: | 105 |
| US Patents: | 7 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 70 |
| Clinical Trials: | 57 |
| Patent Applications: | 2,239 |
| 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 Loss of Exclusivity (LOE) Date for FIRMAGON
*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 |
|---|---|
| Eli Lilly and Company | Phase 1/Phase 2 |
| Bayer | Phase 1/Phase 2 |
| Praful Ravi | Phase 1/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 seven US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of FIRMAGON is ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING PROSTATE CANCER
Methods of treating prostate cancer with GnRH antagonist
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF ADVANCED PROSTATE CANCER WITH A REDUCED LIKELIHOOD OF CAUSING A GONADOTROPHIN RELEASING HORMONE AGONIST SIDE-EFFECT
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF ADVANCED PROSTATE CANCER WITH A REDUCED LIKELIHOOD OF CAUSING A GONADOTROPHIN RELEASING HORMONE AGONIST SIDE-EFFECT
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING PROSTATE CANCER
Method of treating prostate cancer with GnRH antagonist
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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 | ⤷ 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 | 022201-002 | Dec 24, 2008 | RX | Yes | Yes | ⤷ 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 FIRMAGON
| 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 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: ⤷ Sign Up
Patent: 09213751
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 0908127
Estimated Expiration: ⤷ Sign Up
Patent: 0908129
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 14444
Estimated Expiration: ⤷ Sign Up
Patent: 14445
Estimated Expiration: ⤷ Sign Up
China
Patent: 1939020
Estimated Expiration: ⤷ Sign Up
Patent: 1998861
Estimated Expiration: ⤷ Sign Up
Patent: 3990107
Estimated Expiration: ⤷ Sign Up
Patent: 7412726
Estimated Expiration: ⤷ Sign Up
Croatia
Patent: 0140665
Estimated Expiration: ⤷ Sign Up
Patent: 0150290
Estimated Expiration: ⤷ Sign Up
Patent: 0150633
Estimated Expiration: ⤷ Sign Up
Cyprus
Patent: 15561
Estimated Expiration: ⤷ Sign Up
Patent: 16289
Estimated Expiration: ⤷ Sign Up
Patent: 16341
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 49859
Estimated Expiration: ⤷ Sign Up
Patent: 05204
Estimated Expiration: ⤷ Sign Up
Patent: 50012
Estimated Expiration: ⤷ Sign Up
Eurasian Patent Organization
Patent: 7582
Estimated Expiration: ⤷ Sign Up
Patent: 0543
Estimated Expiration: ⤷ Sign Up
Patent: 6521
Estimated Expiration: ⤷ Sign Up
Patent: 6695
Estimated Expiration: ⤷ Sign Up
Patent: 0901074
Estimated Expiration: ⤷ Sign Up
Patent: 0901075
Estimated Expiration: ⤷ Sign Up
Patent: 1300741
Estimated Expiration: ⤷ Sign Up
Patent: 1300742
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 49858
Estimated Expiration: ⤷ Sign Up
Patent: 49859
Estimated Expiration: ⤷ Sign Up
Patent: 05204
Estimated Expiration: ⤷ Sign Up
Patent: 50012
Estimated Expiration: ⤷ Sign Up
Patent: 99085
Estimated Expiration: ⤷ Sign Up
Patent: 60565
Estimated Expiration: ⤷ Sign Up
Patent: 57197
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 45011
Estimated Expiration: ⤷ Sign Up
Patent: 76552
Estimated Expiration: ⤷ Sign Up
Patent: 90912
Estimated Expiration: ⤷ Sign Up
Patent: 98243
Estimated Expiration: ⤷ Sign Up
Patent: 58957
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 7295
Estimated Expiration: ⤷ Sign Up
Patent: 7400
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 76652
Estimated Expiration: ⤷ Sign Up
Patent: 24866
Estimated Expiration: ⤷ Sign Up
Patent: 89234
Estimated Expiration: ⤷ Sign Up
Patent: 54042
Estimated Expiration: ⤷ Sign Up
Patent: 18967
Estimated Expiration: ⤷ Sign Up
Patent: 04003
Estimated Expiration: ⤷ Sign Up
Patent: 18849
Estimated Expiration: ⤷ Sign Up
Patent: 86748
Estimated Expiration: ⤷ Sign Up
Patent: 00029
Estimated Expiration: ⤷ Sign Up
Patent: 11511785
Estimated Expiration: ⤷ Sign Up
Patent: 11511786
Estimated Expiration: ⤷ Sign Up
Patent: 14141505
Estimated Expiration: ⤷ Sign Up
Patent: 14167009
Estimated Expiration: ⤷ Sign Up
Patent: 16193910
Estimated Expiration: ⤷ Sign Up
Patent: 16216455
Estimated Expiration: ⤷ Sign Up
Patent: 18039814
Estimated Expiration: ⤷ Sign Up
Patent: 19059726
Estimated Expiration: ⤷ Sign Up
Patent: 19218360
Estimated Expiration: ⤷ Sign Up
Patent: 20196722
Estimated Expiration: ⤷ Sign Up
Patent: 22133426
Estimated Expiration: ⤷ Sign Up
Patent: 22184898
Estimated Expiration: ⤷ Sign Up
Jordan
Patent: 0090061
Estimated Expiration: ⤷ Sign Up
Patent: 25
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 10008816
Estimated Expiration: ⤷ Sign Up
Patent: 10008817
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 7057
Estimated Expiration: ⤷ Sign Up
Patent: 7088
Estimated Expiration: ⤷ Sign Up
Patent: 3932
Estimated Expiration: ⤷ Sign Up
Patent: 3958
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 49859
Estimated Expiration: ⤷ Sign Up
Patent: 05204
Estimated Expiration: ⤷ Sign Up
Patent: 50012
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 49859
Estimated Expiration: ⤷ Sign Up
Patent: 05204
Estimated Expiration: ⤷ Sign Up
Patent: 50012
Estimated Expiration: ⤷ Sign Up
Russian Federation
Patent: 04393
Estimated Expiration: ⤷ Sign Up
Patent: 04394
Estimated Expiration: ⤷ Sign Up
Patent: 10133480
Estimated Expiration: ⤷ Sign Up
Patent: 10133481
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 49859
Estimated Expiration: ⤷ Sign Up
Patent: 05204
Estimated Expiration: ⤷ Sign Up
Patent: 50012
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 1005697
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 1542480
Estimated Expiration: ⤷ Sign Up
Patent: 100123714
Estimated Expiration: ⤷ Sign Up
Patent: 100126362
Estimated Expiration: ⤷ Sign Up
Patent: 140130757
Estimated Expiration: ⤷ Sign Up
Patent: 150091543
Estimated Expiration: ⤷ Sign Up
Patent: 180118830
Estimated Expiration: ⤷ Sign Up
Patent: 200001623
Estimated Expiration: ⤷ Sign Up
Patent: 210005323
Estimated Expiration: ⤷ Sign Up
Patent: 220009504
Estimated Expiration: ⤷ Sign Up
Patent: 230088848
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 79441
Estimated Expiration: ⤷ Sign Up
Patent: 32709
Estimated Expiration: ⤷ Sign Up
Patent: 40235
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 42932
Estimated Expiration: ⤷ Sign Up
Patent: 39959
Estimated Expiration: ⤷ Sign Up
Patent: 0938217
Estimated Expiration: ⤷ Sign Up
Patent: 0938218
Estimated Expiration: ⤷ Sign Up
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 |
|---|---|---|---|
| World Intellectual Property Organization (WIPO) | 2009101533 | ⤷ Sign Up | |
| New Zealand | 500142 | GnRH antagonists which include modified amino acids at positions 5 and 6 | ⤷ Sign Up |
| European Patent Office | 1003774 | ANTAGONISTES DE GnRH MODIFIES AUX POSITIONS 5 ET 6 (GnRH ANTAGONISTS BEING MODIFIED IN POSITIONS 5 AND 6) | ⤷ Sign Up |
| Russian Federation | 2199549 | АНТАГОНИСТЫ GNRH, МОДИФИЦИРОВАННЫЕ В ПОЛОЖЕНИЯХ 5 И 6 (GNRH ANTAGONISTS MODIFIED AT POSITIONS 5 AND 6) | ⤷ Sign Up |
| Eurasian Patent Organization | 026521 | СПОСОБ ЛЕЧЕНИЯ РАКА ПРЕДСТАТЕЛЬНОЙ ЖЕЛЕЗЫ АНТАГОНИСТОМ ГОНАДОТРОПИН-ВЫСВОБОЖДАЮЩЕГО ГОРМОНА (GnRH) ДЕГАРЕЛИКСОМ (METHOD OF TREATING PROSTATE CANCER WITH GONADOTROPHIN RELEASING HORMONE (GnRH) ANTAGONIST DEGARELIX) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for FIRMAGON
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 | 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 | CA 2009 00022 | Denmark | ⤷ Sign Up | |
| 1003774 | 362 | Finland | ⤷ Sign Up | |
| 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 |
| >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.
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