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FIRMAGON Drug Profile
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See Plans and PricingWhich patents cover Firmagon, and what generic alternatives are available?
Firmagon is a drug marketed by Ferring and is included in one NDA. There are three patents protecting this drug.
This drug has one hundred and thirty-four patent family members in thirty-six 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.
US ANDA Litigation and 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 May 18, 2021. This may change due to patent challenges or generic licensing.
There has been one patent litigation case 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: | 134 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 32 |
| Clinical Trials: | 47 |
| Patent Applications: | 9 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for FIRMAGON |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for FIRMAGON |
| DailyMed Link: | FIRMAGON at DailyMed |
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 |
|---|---|
| Rabin Medical Center | Phase 2 |
| Prostate Cancer Canada | Phase 2 |
| University Health Network, Toronto | Phase 2 |
Recent Litigation for FIRMAGON
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Salk Institute for Biological Studies v. Ferring Pharmaceuticals, Inc | 2010-12-22 |
Synonyms for FIRMAGON
| 214766-78-6 |
| 766D786 |
| 934016-19-0 |
| Ac-D-Nal-[D-(pCl)Phe]-D-Pal-Ser-[Aph(DHor)]-D-[Aph(Cbm)]-Leu-ILys-Pro-DAla-NH2 |
| Acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide |
| AKOS030526717 |
| AN-5181 |
| ASP-3550 |
| ASP3550 |
| BDBM50102450 |
| CHEBI:135961 |
| CHEMBL2028987 |
| CHEMBL415606 |
| CS-5350 |
| D08901 |
| D09400 |
| DB06699 |
| Degarelix |
| Degarelix (acetate) pound>>FE 200486 |
| Degarelix (INN/USAN) |
| Degarelix [USAN:INN:BAN] |
| Degarelix acetate |
| Degarelix acetate (JAN) |
| Degarelix monoacetate |
| EXT215F4ZU |
| FE 200486 |
| FE-200486 |
| FE-200486 (free base) |
| FE200486 |
| FE200486 (AS ACETATE SALT) |
| Firmagon (TN) |
| Gonax |
| GTPL5585 |
| HSDB 7817 |
| HY-16168A |
| QC-10170 |
| RL02641 |
| SCHEMBL1397034 |
| SX0XJI3A11 |
| Uglypeptide1 |
| UNII-EXT215F4ZU |
| UNII-SX0XJI3A11 |
| Z-3147 |
Paragraph IV (Patent) Challenges for FIRMAGON
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| FIRMAGON | POWDER;SUBCUTANEOUS | degarelix acetate | 022201 | 2019-12-20 |
US Patents and Regulatory Information for 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 | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Ferring | FIRMAGON | degarelix acetate | POWDER;SUBCUTANEOUS | 022201-002 | Dec 24, 2008 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Ferring | FIRMAGON | degarelix acetate | POWDER;SUBCUTANEOUS | 022201-001 | Dec 24, 2008 | RX | Yes | No | Start Trial | Start Trial | Start 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
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 2014141505 | Start Trial |
| Brazil | PI0908129 | Start Trial |
| Poland | 336213 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for FIRMAGON
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1003774 | PA2009005,C1003774 | Lithuania | Start Trial | PRODUCT NAME: DEGARELIXUM ACETAT; REGISTRATION NO/DATE: EU/1/08/504/001, 2009 02 17 EU/1/08/504/002 20090217 |
| 1003774 | 09C0028 | France | Start 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 | 300395 | Netherlands | Start Trial | 300395, 20180413, EXPIRES: 20230412 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
