Degarelix acetate - Generic Drug Details
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What are the generic sources for degarelix acetate and what is the scope of patent protection?
Degarelix acetate
is the generic ingredient in one branded drug marketed by Ferring and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.Degarelix acetate has ninety-five patent family members in twenty-four countries.
One supplier is listed for this compound.
Summary for degarelix acetate
| International Patents: | 95 |
| US Patents: | 5 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 49 |
| Clinical Trials: | 36 |
| Patent Applications: | 5,636 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for degarelix acetate |
| DailyMed Link: | degarelix acetate at DailyMed |
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 |
Anatomical Therapeutic Chemical (ATC) Classes for degarelix acetate
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
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 | 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 degarelix acetate
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Eurasian Patent Organization | 200901075 | СПОСОБ ЛЕЧЕНИЯ РАКА ПРЕДСТАТЕЛЬНОЙ ЖЕЛЕЗЫ АНТАГОНИСТОМ ГОНАДОТРОПИН-ВЫСВОБОЖДАЮЩЕГО ГОРМОНА (GnRH) ДЕГАРЕЛИКСОМ | See Plans and Pricing |
| Cyprus | 1116341 | See Plans and Pricing | |
| Eurasian Patent Organization | 200901074 | ЛЕЧЕНИЕ МЕТАСТАТИЧЕСКОЙ СТАДИИ РАКА ПРЕДСТАТЕЛЬНОЙ ЖЕЛЕЗЫ ДЕГАРЕЛИКСОМ | See Plans and Pricing |
| Australia | 2009213751 | Treatment of metastatic stage prostate cancer with degarelix | See Plans and Pricing |
| Denmark | 2650012 | See Plans and Pricing | |
| Japan | 6254042 | See Plans and Pricing | |
| >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 | 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 | SPC/GB09/028 | United Kingdom | See Plans and Pricing | 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 | See Plans and Pricing | PRODUCT NAME: DEGARELIX, EVENTUELLEMENT UN SEL PHARMACEUTIQUEMENT ACCEPTABE, TEL QUE L'ACETATE (FIRMAGON); REG. DATE: 20090217 |
| 1003774 | C01003774/01 | Switzerland | See Plans and Pricing | PRODUCT NAME: DEGARELIX; REGISTRATION NUMBER/DATE: SWISSMEDIC 59455 12.02.2010 |
| 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 |
| 1003774 | 122009000033 | Germany | See Plans and Pricing | PRODUCT NAME: DEGARELIX, GGF. IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES DAVON, WIE DEM ACETAT; REGISTRATION NO/DATE: EU/1/08/504/001-002 20090217 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
