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Last Updated: February 28, 2020

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FIRAZYR Drug Profile


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When do Firazyr patents expire, and what generic alternatives are available?

Firazyr is a drug marketed by Shire Orphan Therap and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has one hundred and fourteen patent family members in thirty-three countries.

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

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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
ShirePhase 1
PPDPhase 3
Massachusetts General HospitalPhase 4

See all FIRAZYR clinical trials

Recent Litigation for FIRAZYR

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District Court Litigation
Case NameDate
Shire Orphan Therapies LLC v. InnoPharma Inc.2016-06-17
Shire Orphan Therapies LLC v. Fresenius Kabi USA, LLC2015-11-30

See all FIRAZYR litigation

Pharmacology for FIRAZYR
Synonyms for FIRAZYR
130308-48-4
130308-48-4 (Parent)
138614-30-9
138614-30-9 (acetate)
325O8467XK
3729AH
7PG89G35Q7
AC1OCF3R
AC1OCF3T
BDBM50403371
BDBM50406750
C59H89N19O13S
CHEMBL2028850
CHEMBL2028852
CS-3381
D-Arg-L-Arg-L-Pro-L-Hyp-Gly-L-(2-thienyl)Ala-L-Ser-D-1,2,3,4-tetrahydro-3-isoquinolinecarbonyl-L-(2|A,3|A,7a|A)-octahydro-1H-indole-2-carbonyl-L-Arg
HOE 140
HOE 140, >=94%
Hoe-140
HOE-140 (Icatibant)
HOE140
HOE140;HOE 140;HOE-140
Hoechst 140
HY-17446
Icatibant
Icatibant [INN:BAN]
Icatibant acetate
Icatibant acetate [USAN]
JE 049
JE-049
L-Arginine, D-arginyl-L-arginyl-L-prolyl-trans-4-hydroxy-L-prolylglycyl-3-(2-thienyl)-L-alanyl-L-seryl-D-1,2,3,4-tetrahydro-3-isoquinolinecarbonyl-L-(2alpha,3abeta,7abeta)-octahydro-1H-indole-2-carbonyl-
L-Arginine, D-arginyl-L-arginyl-L-prolyl-trans-4-hydroxy-L-prolylglycyl-3-(2-thienyl)-L-alanyl-L-seryl-D-1,2,3,4-tetrahydro-3-isoquinolinecarbonyl-L-(2alpha,3abeta,7abeta)-octahydro-1H-indole-2-carbonyl-, acetate (salt)
UNII-325O8467XK
UNII-7PG89G35Q7
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 Y Y   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 300359 Netherlands   Start Trial 300359, 20091121, EXPIRES: 20141120
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
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 91499 Luxembourg   Start Trial 91499, EXPIRES: 20141121
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
McKinsey
Johnson and Johnson
McKesson
Moodys
Merck

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