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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Healthtrust
Covington
US Department of Justice
McKinsey
Merck
Cantor Fitzgerald
Argus Health
Fish and Richardson

Generated: July 21, 2018

DrugPatentWatch Database Preview

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 twelve drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the icatibant acetate profile page.
Drug patent expirations by year for FIRAZYR
Generic Entry Opportunity Date for FIRAZYR
Generic Entry Date for FIRAZYR*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage::
INJECTABLE;SUBCUTANEOUS

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for FIRAZYR
Synonyms for FIRAZYR
(2S)-2-[[(3aS,7aS)-1-[2-[(2S)-2-[[(2S)-2-[[2-[[(4R)-1-[1-[2-[[(2R)-2-amino-5-(diaminomethylideneamino)pentanoyl]amino]-5-(diaminomethylideneamino)pentanoyl]pyrrolidine-2-carbonyl]-4-hydroxy-pyrrolidine-2-carbonyl]amino]acetyl
130308-48-4
138614-30-9
138614-30-9 (acetate)
3729AH
7PG89G35Q7
AC1L2G0Q
AC1OCF3T
AC1Q5QRX
BDBM50403371
BDBM50406750
C59H89N19O13S
CHEMBL2028850
CS-3381
CTK0H7019
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
D-Arg(Hyp(3)-Thi(5)-D-Tic(7)-Oic(8))BK
D04ZBT
DB06196
HOE 140
HOE 140 Acetate
HOE 140, >=94%
Hoe-140
HOE-140 (Icatibant)
HOE140
HOE140;HOE 140;HOE-140
Hoechst 140
HY-17446
Icatibant
Icatibant [INN:BAN]
Icatibant [INN]
Icatibant acetate
JE 049
JE049
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-
LS-172762
SCHEMBL15992443
UNII-7PG89G35Q7
WIN 65365
WIN-65365

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 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Shire Orphan Therap FIRAZYR icatibant acetate INJECTABLE;SUBCUTANEOUS 022150-001 Aug 25, 2011 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

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

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Supplementary Protection Certificates for FIRAZYR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0359 Netherlands ➤ Sign Up 300359, 20091121, EXPIRES: 20141120
/2008 Austria ➤ Sign Up PRODUCT NAME: ICATIBANT, WAHLWEISE IN FORM EINES PHYSIOLOGISCH ANNEHMBAREN SALZES, EINSCHLIESSLICH ICATIBANT-ACETAT; REGISTRATION NO/DATE: EU/1/08/461/001 20080711
499 Luxembourg ➤ Sign Up 91499, EXPIRES: 20141121
00359 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Chinese Patent Office
Covington
Fish and Richardson
US Department of Justice
Accenture
Express Scripts
McKesson
Colorcon

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.