Degarelix acetate - Generic Drug Details
✉ Email this page to a colleague
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 seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.Degarelix acetate has one hundred and four patent family members in twenty-four countries.
One supplier is listed for this compound.
Summary for degarelix acetate
International Patents: | 104 |
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
Generic Entry Date for degarelix acetate*:
Constraining patent/regulatory exclusivity:
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 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
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Ferring | FIRMAGON | degarelix acetate | POWDER;SUBCUTANEOUS | 022201-001 | Dec 24, 2008 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Ferring | FIRMAGON | degarelix acetate | POWDER;SUBCUTANEOUS | 022201-001 | Dec 24, 2008 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Ferring | FIRMAGON | degarelix acetate | POWDER;SUBCUTANEOUS | 022201-002 | Dec 24, 2008 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Ferring | FIRMAGON | degarelix acetate | POWDER;SUBCUTANEOUS | 022201-002 | Dec 24, 2008 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Ferring | FIRMAGON | degarelix acetate | POWDER;SUBCUTANEOUS | 022201-002 | Dec 24, 2008 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Ferring | FIRMAGON | degarelix acetate | POWDER;SUBCUTANEOUS | 022201-001 | Dec 24, 2008 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
>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 | ⤷ Try a Trial | ⤷ Try a Trial |
Ferring | FIRMAGON | degarelix acetate | POWDER;SUBCUTANEOUS | 022201-002 | Dec 24, 2008 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for degarelix acetate
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
World Intellectual Property Organization (WIPO) | 2009101530 | ⤷ Try a Trial | |
Hong Kong | 1176552 | 使用 拮抗劑地加瑞克治療前列腺癌的方法 (METHOD OF TREATING PROSTATE CANCER WITH THE GNRH ANTAGONIST DEGARELIX GNRH) | ⤷ Try a Trial |
European Patent Office | 2249859 | TRAITEMENT DU CANCER DE LA PROSTATE AU STADE MÉTASTASIQUE PAR LE DEGARELIX (TREATMENT OF METASTATIC STAGE PROSTATE CANCER WITH DEGARELIX) | ⤷ Try a Trial |
Russian Federation | 2504393 | СПОСОБ ЛЕЧЕНИЯ РАКА ПРЕДСТАТЕЛЬНОЙ ЖЕЛЕЗЫ АНТАГОНИСТОМ ГОНАДОТРОПИН-ВЫСВОБОЖДАЮЩЕГО ГОРМОНА (GnRH) ДЕГАРЕЛИКСОМ (METHOD OF TREATING PROSTATE CANCER WITH DEGARELIX THAT IS GONADOTROPIN-RELEASING HORMONE (GnRH) ANTAGONIST) | ⤷ Try a Trial |
Spain | 2532709 | ⤷ Try a Trial | |
Japan | 2019059726 | 転移期前立腺癌を治療する方法 (METHODS OF TREATING METASTATIC STAGE PROSTATE CANCER) | ⤷ Try a Trial |
European Patent Office | 2650012 | Traitement du cancer de la prostate au stade métastasique par le degarelix (Treatment of metastatic stage prostate cancer with degarelix) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for degarelix acetate
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1003774 | 09C0028 | France | ⤷ Try a 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 | 122009000033 | Germany | ⤷ Try a Trial | 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 | PA2009005 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: DEGARELIXUM ACETAT; REGISTRATION NO/DATE: EU/1/08/504/001, 2009 02 17 EU/1/08/504/002 20090217 |
1003774 | PA2009005,C1003774 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: DEGARELIXUM ACETAT; REGISTRATION NO/DATE: EU/1/08/504/001, 2009 02 17 EU/1/08/504/002 20090217 |
1003774 | 91585 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: DEGARELIX, EVENTUELLEMENT UN SEL PHARMACEUTIQUEMENT ACCEPTABE, TEL QUE L'ACETATE (FIRMAGON); REG. DATE: 20090217 |
1003774 | SPC/GB09/028 | United Kingdom | ⤷ Try a 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 | C01003774/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: DEGARELIX; REGISTRATION NUMBER/DATE: SWISSMEDIC 59455 12.02.2010 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |