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Last Updated: January 15, 2021

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FIRMAGON Drug Profile

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Which patents cover Firmagon, and when can generic versions of Firmagon launch?

Firmagon is a drug marketed by Ferring and is included in one NDA. There are five patents protecting this drug.

This drug has one hundred and thirty-eight 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.

US ANDA Litigation and Generic Entry Outlook for Firmagon

Firmagon was eligible for patent challenges on December 24, 2012.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 18, 2021. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for FIRMAGON
Drug Prices for FIRMAGON

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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

SponsorPhase
NRG OncologyPhase 3
Centre Leon BerardPhase 2
Rabin Medical CenterPhase 2

See all FIRMAGON clinical trials

Paragraph IV (Patent) Challenges for FIRMAGON
Tradename Dosage Ingredient NDA Submissiondate
FIRMAGON POWDER;SUBCUTANEOUS degarelix acetate 022201 2019-12-20

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   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 022201-002 Dec 24, 2008 RX Yes Yes   Start Trial   Start Trial Y Y   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 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

Supplementary Protection Certificates for FIRMAGON

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1003774 SPC020/2009 Ireland   Start Trial SPC020/2009: 20091119, EXPIRES: 20230412
1003774 300395 Netherlands   Start Trial 300395, 20180413, EXPIRES: 20230412
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 122009000033 Germany   Start 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 362 Finland   Start Trial
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Baxter
McKinsey

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