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Last Updated: August 19, 2022

FIRAZYR Drug Patent Profile


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

Firazyr is a drug marketed by Shire Orphan Therap and is included in one NDA.

The generic ingredient in FIRAZYR is icatibant acetate. There are thirteen drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the icatibant acetate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Firazyr

A generic version of FIRAZYR was approved as icatibant acetate by TEVA PHARMS USA on July 15th, 2019.

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Summary for FIRAZYR
Drug patent expirations by year for FIRAZYR
Drug Prices for FIRAZYR

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Recent Clinical Trials for FIRAZYR

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SponsorPhase
Sebastian VidelaPhase 2
Kalispell Regional Medical CenterPhase 2
University of California, San DiegoPhase 2

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Pharmacology for FIRAZYR
Paragraph IV (Patent) Challenges for FIRAZYR
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
FIRAZYR Injection icatibant acetate 10 mg/mL 022150 2 2015-08-25

US Patents and Regulatory Information for FIRAZYR

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Shire Orphan Therap FIRAZYR icatibant acetate INJECTABLE;SUBCUTANEOUS 022150-001 Aug 25, 2011 AP 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

International Patents for FIRAZYR

See the table below for patents covering FIRAZYR around the world.

Country Patent Number Title Estimated Expiration
Russian Federation 2081880 PEPTIDE DERIVATIVES See Plans and Pricing
South Africa 9103121 See Plans and Pricing
Hungary 210712 See Plans and Pricing
Portugal 91692 PROCESSO PARA A PREPARACAO DE PEPTIDEOS COM ACTIVIDADE ANTAGONISTA DA BRADIQUININA See Plans and Pricing
Hungary T60286 See Plans and Pricing
New Zealand 230244 PEPTIDES WITH BRADYKININ ANTAGONIST ACTIVITY AND PHARMACEUTICAL COMPOSITIONS See Plans and Pricing
Spain 2065445 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for FIRAZYR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0370453 300359 Netherlands See Plans and Pricing 300359, 20091121, EXPIRES: 20141120
0370453 09C0002 France See Plans and Pricing PRODUCT NAME: ICATIBANT, EVENTUELLEMENT SOUS FORME DE SEL PHYSIOLOGIQUEMENT ACCEPTABLE, NOTAMMENT L?ACETATE D?ICATIBANT; REGISTRATION NO/DATE IN FRANCE: EU/1/08/461/001 DU 20080711; REGISTRATION NO/DATE AT EEC: EU/1/08/461/001 DU 20080711
0370453 C300359 Netherlands See Plans and Pricing PRODUCT NAME: ICATIBANT, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, BIJ VOORKEUR ICATIBANTACETAAT; REGISTRATION NO/DATE: EU/1/048/461/001 20080711
0370453 51/2008 Austria See Plans and Pricing PRODUCT NAME: ICATIBANT, WAHLWEISE IN FORM EINES PHYSIOLOGISCH ANNEHMBAREN SALZES, EINSCHLIESSLICH ICATIBANT-ACETAT; REGISTRATION NO/DATE: EU/1/08/461/001 20080711
0370453 91499 Luxembourg See Plans and Pricing 91499, EXPIRES: 20141121
0370453 SPC/GB09/002 United Kingdom See Plans and Pricing PRODUCT NAME: ICATIBANT, OR A PHYSIOLOGICALLY TOLERABLE SALT THEREOF, INCLUDING ICATIBANT ACETATE; REGISTERED: UK EU/1/08/461/001 20080711
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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