DEGARELIX ACETATE - Generic Drug Details
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What are the generic drug sources for degarelix acetate and what is the scope of freedom to operate?
Degarelix acetate
is the generic ingredient in one branded drug marketed by Ferring and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.Degarelix acetate has one hundred and five patent family members in twenty-four countries.
One supplier is listed for this compound.
Summary for DEGARELIX ACETATE
| International Patents: | 105 |
| US Patents: | 7 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 21 |
| Clinical Trials: | 36 |
| Patent Applications: | 120 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for DEGARELIX ACETATE |
| DailyMed Link: | DEGARELIX ACETATE at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for DEGARELIX ACETATE
*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 DEGARELIX ACETATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Fudan University | Phase 2 |
| Alliance for Clinical Trials in Oncology | Phase 3 |
| Myovant Sciences GmbH | Phase 1 |
Paragraph IV (Patent) Challenges for DEGARELIX ACETATE
| 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 DEGARELIX ACETATE
| 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 | 022201-002 | 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 | ||||
| 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 DEGARELIX ACETATE
| 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 DEGARELIX ACETATE
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Eurasian Patent Organization | 201300742 | СПОСОБ ЛЕЧЕНИЯ РАКА ПРЕДСТАТЕЛЬНОЙ ЖЕЛЕЗЫ АНТАГОНИСТОМ ГОНАДОТРОПИН-ВЫСВОБОЖДАЮЩЕГО ГОРМОНА (GNRH) ДЕГАРЕЛИКСОМ | ⤷ Sign Up |
| European Patent Office | 4257197 | PROCÉDÉ DE TRAITEMENT DU CANCER DE LA PROSTATE AVEC DEGARELIX (TREATMENT OF METASTATIC STAGE PROSTATE CANCER WITH DEGARELIX) | ⤷ Sign Up |
| Canada | 3235099 | PROCEDE DE TRAITEMENT DU CANCER DE LA PROSTATE PAR LE DEGARELIX, ANTAGONISTE DE GNRH (METHOD OF TREATING PROSTATE CANCER WITH THE GNRH ANTAGONIST DEGARELIX) | ⤷ Sign Up |
| China | 101939020 | Treatment of metastatic stage prostate cancer with degarelix | ⤷ Sign Up |
| Denmark | 2249859 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for DEGARELIX ACETATE
| 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 | 122009000033 | Germany | ⤷ Sign Up | PRODUCT NAME: DEGARELIX, GGF. IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES DAVON, WIE DEM ACETAT; REGISTRATION NO/DATE: EU/1/08/504/001-002 20090217 |
| 1003774 | 91585 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: DEGARELIX, EVENTUELLEMENT UN SEL PHARMACEUTIQUEMENT ACCEPTABE, TEL QUE L'ACETATE (FIRMAGON); REG. DATE: 20090217 |
| 1003774 | C01003774/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: DEGARELIX; REGISTRATION NUMBER/DATE: SWISSMEDIC 59455 12.02.2010 |
| 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 |
