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Last Updated: November 4, 2024

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 Takeda Pharms Usa and is included in one NDA.

The generic ingredient in FIRAZYR is icatibant acetate. There are thirteen drug master file entries for this compound. Eleven 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

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

SponsorPhase
Sebastian VidelaPhase 2
University of Southern CaliforniaPhase 2
Georgetown UniversityPhase 2

See all FIRAZYR clinical trials

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
Takeda Pharms Usa FIRAZYR icatibant acetate INJECTABLE;SUBCUTANEOUS 022150-001 Aug 25, 2011 AP RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 FIRAZYR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0370453 91499 Luxembourg ⤷  Sign Up 91499, EXPIRES: 20141121
0370453 C300359 Netherlands ⤷  Sign Up 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 SPC/GB09/002 United Kingdom ⤷  Sign Up 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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