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Last Updated: February 20, 2020

DrugPatentWatch Database Preview

FIRMAGON Drug Profile


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Which patents cover Firmagon, and what generic alternatives are available?

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

This drug has one hundred and thirty-four 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
Rabin Medical CenterPhase 2
Prostate Cancer CanadaPhase 2
University Health Network, TorontoPhase 2

See all FIRMAGON clinical trials

Recent Litigation for FIRMAGON

Identify potential future generic entrants

District Court Litigation
Case NameDate
Salk Institute for Biological Studies v. Ferring Pharmaceuticals, Inc2010-12-22

See all FIRMAGON litigation

Synonyms for FIRMAGON
214766-78-6
766D786
934016-19-0
Ac-D-Nal-[D-(pCl)Phe]-D-Pal-Ser-[Aph(DHor)]-D-[Aph(Cbm)]-Leu-ILys-Pro-DAla-NH2
Acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide
AKOS030526717
AN-5181
ASP-3550
ASP3550
BDBM50102450
CHEBI:135961
CHEMBL2028987
CHEMBL415606
CS-5350
D08901
D09400
DB06699
Degarelix
Degarelix (acetate) pound>>FE 200486
Degarelix (INN/USAN)
Degarelix [USAN:INN:BAN]
Degarelix acetate
Degarelix acetate (JAN)
Degarelix monoacetate
EXT215F4ZU
FE 200486
FE-200486
FE-200486 (free base)
FE200486
FE200486 (AS ACETATE SALT)
Firmagon (TN)
Gonax
GTPL5585
HSDB 7817
HY-16168A
QC-10170
RL02641
SCHEMBL1397034
SX0XJI3A11
Uglypeptide1
UNII-EXT215F4ZU
UNII-SX0XJI3A11
Z-3147
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 Y Y   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
>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 PA2009005,C1003774 Lithuania   Start Trial PRODUCT NAME: DEGARELIXUM ACETAT; REGISTRATION NO/DATE: EU/1/08/504/001, 2009 02 17 EU/1/08/504/002 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 300395 Netherlands   Start Trial 300395, 20180413, EXPIRES: 20230412
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Medtronic
Harvard Business School
AstraZeneca
Merck
Johnson and Johnson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.