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Last Updated: August 8, 2020

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FIRAZYR Drug 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. Three suppliers are listed for this compound. Additional details are available on the icatibant acetate profile page.

US ANDA 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.

  Start Trial

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

See drug prices for FIRAZYR

Recent Clinical Trials for FIRAZYR

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

SponsorPhase
ShirePhase 1
PPDPhase 3
Shire Human Genetic Therapies, Inc.Phase 4

See all FIRAZYR clinical trials

Pharmacology for FIRAZYR
Paragraph IV (Patent) Challenges for FIRAZYR
Tradename Dosage Ingredient NDA Submissiondate
FIRAZYR INJECTABLE;SUBCUTANEOUS icatibant acetate 022150 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   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 FIRAZYR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0370453 51/2008 Austria   Start Trial 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   Start Trial 91499, EXPIRES: 20141121
0370453 SPC/GB09/002 United Kingdom   Start Trial PRODUCT NAME: ICATIBANT, OR A PHYSIOLOGICALLY TOLERABLE SALT THEREOF, INCLUDING ICATIBANT ACETATE; REGISTERED: UK EU/1/08/461/001 20080711
0370453 09C0002 France   Start Trial 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   Start Trial PRODUCT NAME: ICATIBANT, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, BIJ VOORKEUR ICATIBANTACETAAT; REGISTRATION NO/DATE: EU/1/048/461/001 20080711
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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