Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: October 20, 2019

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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 freedom to operate?

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

Icatibant acetate has one hundred and fourteen patent family members in thirty-three countries.

There are thirteen drug master file entries for icatibant acetate. Two suppliers are listed for this compound.

Recent Litigation for icatibant acetate

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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 icatibant acetate litigation

Pharmacology for icatibant acetate
Synonyms for icatibant acetate
130308-48-4
130308-48-4 (Parent)
138614-30-9
138614-30-9 (acetate)
325O8467XK
3729AH
7PG89G35Q7
AC1L2G0N
AC1L2G0Q
AC1NSK4W
AC1OCF3R
AC1OCF3T
AC1Q5QRX
BDBM50403371
BDBM50406750
C59H89N19O13S
C59H89N19O13S.C2H4O2
CHEMBL2028850
CHEMBL2028852
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-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
D-Arg(Hyp(3)-Thi(5)-D-Tic(7)-Oic(8))BK
DB06196
Firazyr
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 [USAN]
JE 049
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-
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-172762
LS-21585
MFCD00213940
SCHEMBL12813034
SCHEMBL15992443
UNII-325O8467XK
UNII-7PG89G35Q7

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 AP RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Teva Pharms Usa ICATIBANT ACETATE icatibant acetate INJECTABLE;SUBCUTANEOUS 210118-001 Jul 15, 2019 AP RX No No   Start Trial   Start Trial   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 icatibant acetate

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
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
0370453 300359 Netherlands   Start Trial 300359, 20091121, EXPIRES: 20141120
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Merck
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AstraZeneca
Medtronic
Moodys
Johnson and Johnson

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