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FIRMAGON Drug Profile

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Which patents cover Firmagon, and what substitute generic drugs are available?

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

This drug has one hundred and five patent family members in thirty-five 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.

Summary for Tradename: FIRMAGON

Patents:2
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Bulk Api Vendors: see list14
Clinical Trials: see list35
Patent Applications: see list8
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:FIRMAGON at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ferring
FIRMAGON
degarelix acetate
POWDER;SUBCUTANEOUS022201-001Dec 24, 2008RXYesNo5,925,730► SubscribeYY ► Subscribe
Ferring
FIRMAGON
degarelix acetate
POWDER;SUBCUTANEOUS022201-002Dec 24, 2008RXYesYes9,415,085► Subscribe ► Subscribe
Ferring
FIRMAGON
degarelix acetate
POWDER;SUBCUTANEOUS022201-001Dec 24, 2008RXYesNo9,415,085► Subscribe ► Subscribe
Ferring
FIRMAGON
degarelix acetate
POWDER;SUBCUTANEOUS022201-002Dec 24, 2008RXYesYes5,925,730► SubscribeYY ► Subscribe
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Non-Orange Book Patents for Tradename: FIRMAGON

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,214,798 GnRH antagonists being modified in positions 5 and 6► Subscribe
8,841,081Method of treating metastatic stage prostate cancer► Subscribe
9,579,359Method of treating prostate cancer with GnRH antagonist► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: FIRMAGON

Country Document Number Estimated Expiration
CroatiaP20150290► Subscribe
Estonia9900479► Subscribe
BrazilPI0908127► Subscribe
Japan2014167009► Subscribe
European Patent Office2249859► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: FIRMAGON

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C020/2009Ireland► SubscribeSPC020/2009: 20091119, EXPIRES: 20230412
2009005Lithuania► SubscribePRODUCT NAME: DEGARELIXUM ACETAT; REGISTRATION NO/DATE: EU/1/08/504/001, 2009 02 17 EU/1/08/504/002 20090217
2009 00022Denmark► Subscribe
C/GB09/028United Kingdom► SubscribePRODUCT 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
0395Netherlands► Subscribe300395, 20180413, EXPIRES: 20230412
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