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Serving hundreds of leading biopharmaceutical companies globally:

Healthtrust
Julphar
Teva
Argus Health
Merck
McKinsey
McKesson
Chinese Patent Office
Daiichi Sankyo

Generated: September 21, 2018

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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. There is one patent protecting this drug and one Paragraph IV challenge.

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
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Supplementary Protection Certificates for FIRAZYR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/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
0359 Netherlands ➤ Sign Up 300359, 20091121, EXPIRES: 20141120
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:

Healthtrust
Julphar
Teva
Argus Health
Merck
McKinsey
McKesson
Chinese Patent Office
Daiichi Sankyo

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.