Get our Free Patent Expiration Newsletter

Serving leading biopharmaceutical companies globally:

Medtronic
AstraZeneca
Harvard Business School
Boehringer Ingelheim
Johnson and Johnson
Mallinckrodt

Last Updated: October 20, 2019

DrugPatentWatch Database Preview

FIRAZYR Drug Profile

See Plans and Pricing

« Back to Dashboard

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.

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
Massachusetts General HospitalPhase 4

See all FIRAZYR clinical trials

Recent Litigation for FIRAZYR

Identify potential future generic entrants

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

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
Paragraph IV (Patent) Challenges for FIRAZYR
Drugname Dosage Strength RLD Date
➤ Subscribe Injection 10 mg/mL ➤ Subscribe   Start Trial

Supplementary Protection Certificates for FIRAZYR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 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

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Merck
Baxter
Harvard Business School
Johnson and Johnson
Mallinckrodt
Express Scripts

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.