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Last Updated: December 3, 2022

Degarelix acetate - Generic Drug Details


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What are the generic 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 five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Degarelix acetate has ninety-eight patent family members in twenty-four countries.

One supplier is listed for this compound.

Recent Clinical Trials for degarelix acetate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Fudan UniversityPhase 2
Alliance for Clinical Trials in OncologyPhase 3
Myovant Sciences GmbHPhase 1

See all degarelix acetate clinical trials

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Ferring FIRMAGON degarelix acetate POWDER;SUBCUTANEOUS 022201-001 Dec 24, 2008 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Ferring FIRMAGON degarelix acetate POWDER;SUBCUTANEOUS 022201-002 Dec 24, 2008 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Ferring FIRMAGON degarelix acetate POWDER;SUBCUTANEOUS 022201-002 Dec 24, 2008 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Ferring FIRMAGON degarelix acetate POWDER;SUBCUTANEOUS 022201-001 Dec 24, 2008 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Ferring FIRMAGON degarelix acetate POWDER;SUBCUTANEOUS 022201-001 Dec 24, 2008 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Ferring FIRMAGON degarelix acetate POWDER;SUBCUTANEOUS 022201-002 Dec 24, 2008 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 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
Japan 2014141505 METHOD OF TREATING PROSTATE CANCER WITH GNRH ANTAGONIST DEGARELIX See Plans and Pricing
Eurasian Patent Organization 201300741 СПОСОБ ЛЕЧЕНИЯ РАКА ПРЕДСТАТЕЛЬНОЙ ЖЕЛЕЗЫ АНТАГОНИСТОМ ГОНАДОТРОПИН-ВЫСВОБОЖДАЮЩЕГО ГОРМОНА (GnRH) ДЕГАРЕЛИКСОМ See Plans and Pricing
South Korea 20150091543 TREATMENT OF METASTATIC STAGE PROSTATE CANCER WITH DEGARELIX See Plans and Pricing
Jordan 3525 علاج سرطان البروستاتا في المرحلة النقيلية بدواء ديجاريليكس (TREATMENT OF METASTATIC STAGE PROSTATE CANCER WITH DEGARELIX) See Plans and Pricing
South Korea 20100126362 METHOD OF TREATING PROSTATE CANCER WITH THE GNRH ANTAGONIST DEGARELIX See Plans and Pricing
New Zealand 587088 TREATMENT OF METASTATIC STAGE PROSTATE CANCER WITH DEGARELIX See Plans and Pricing
European Patent Office 2249859 TRAITEMENT DU CANCER DE LA PROSTATE AU STADE MÉTASTASIQUE PAR LE DEGARELIX (TREATMENT OF METASTATIC STAGE PROSTATE CANCER WITH DEGARELIX) 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 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 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 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 C01003774/01 Switzerland See Plans and Pricing PRODUCT NAME: DEGARELIX; REGISTRATION NUMBER/DATE: SWISSMEDIC 59455 12.02.2010
1003774 PA2009005 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 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

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Serving leading biopharmaceutical companies globally:

Express Scripts
Medtronic
Moodys
Johnson and Johnson
AstraZeneca
Mallinckrodt

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