DrugPatentWatch Database Preview
FIRMAGON Drug Profile
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 three patents protecting this drug.
This drug has one hundred and thirty 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.
Summary for FIRMAGON
| International Patents: | 130 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 32 |
| Clinical Trials: | 43 |
| 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 |
|---|---|
| Regeneron Pharmaceuticals | Phase 2 |
| Mark Stein | Phase 2 |
| Assistance Publique - Hôpitaux de Paris | 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 |
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 | ||||
| Ferring | FIRMAGON | degarelix acetate | POWDER;SUBCUTANEOUS | 022201-001 | Dec 24, 2008 | RX | Yes | No | Start Trial | Start Trial | 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 | 022201-002 | Dec 24, 2008 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | 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 |
|---|---|---|
| South Korea | 20140130757 | Start Trial |
| South Africa | 9803062 | Start Trial |
| South Korea | 20180118830 | Start Trial |
| Netherlands | 300395 | Start Trial |
| China | 1259959 | Start Trial |
| European Patent Office | 2505204 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for FIRMAGON
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1003774 | 362 | Finland | Start Trial | |
| 1003774 | SPC/GB09/028 | United Kingdom | Start Trial | PRODUCT NAME: DEGARELIX OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT SUCH AS THE ACETATE; REGISTERED: UK EU/1/08/504/001 20090217; UK EU/1/08/504/002 20090217 |
| 1003774 | 91585 | Luxembourg | Start Trial | PRODUCT NAME: DEGARELIX, EVENTUELLEMENT UN SEL PHARMACEUTIQUEMENT ACCEPTABE, TEL QUE L'ACETATE (FIRMAGON); REG. DATE: 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 | 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 | PA2009005 | Lithuania | Start Trial | PRODUCT NAME: DEGARELIXUM ACETAT; REGISTRATION NO/DATE: EU/1/08/504/001, 2009 02 17 EU/1/08/504/002 20090217 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
