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Generated: September 23, 2018

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Icatibant acetate - Generic Drug Details

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What are the generic sources for icatibant acetate and what is the scope of icatibant acetate freedom to operate?

Icatibant acetate is the generic ingredient in one branded drug marketed by Shire Orphan Therap and is included in one NDA. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are twelve drug master file entries for icatibant acetate. One supplier is listed for this compound.

Pharmacology for icatibant acetate
Synonyms for icatibant acetate
(R)-Arginyl-(S)-arginyl-(S)-prolyl-(2S,4R)-(4-hydroxyprolyl)glycyl-(S)-(3-(2-thienyl)alanyl)-(S)-seryl-(R)-((1,2,3,4-tetrahydro-3-isoquinolyl)carbonyl)-(2S,3aS,7aS)-((hexahydro-2-indolinyl)carbonyl)-(S)-arginine acetate (salt
130308-48-4
130308-48-4 (Parent)
138614-30-9
138614-30-9 (acetate)
325O8467XK
3729AH
3B1-001177
7PG89G35Q7
AC1L2G0N
AC1NSK4W
AC1OCF3R
AC1OCF3T
ACETIC ACID; ICATIBANT
AM006836
BDBM50403371
BDBM50406750
C59H89N19O13S
C59H89N19O13S.C2H4O2
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
D-Arg-L-Arg-L-Pro-L-Hyp-Gly-L-(2-thienyl)Ala-L-Ser-D-1,2,3,4-tetrahydro-3-isoquinolinecarbonyl-L-(2alpha,3beta,7abeta)-octahydro-1H-indole-2-carbonyl-L-Arg
Firazyr
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 [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)
LS-21585
MFCD00213940
SCHEMBL12813034
UNII-325O8467XK
UNII-7PG89G35Q7
WIN 65365
WIN-65365

US Patents and Regulatory Information for icatibant acetate

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

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
/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
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
C0002 France ➤ Sign Up 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Citi
Fuji
Deloitte
AstraZeneca
US Department of Justice
US Army
Chinese Patent Office
Healthtrust

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