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Icatibant acetate - Generic Drug Details

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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.

This ingredient has one hundred and twelve patent family members in thirty-three countries.

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

Summary for Generic Name: icatibant acetate

Tradenames:1
Patents:1
Applicants:1
NDAs:1
Drug Master File Entries: see list7
Suppliers / Packaging: see list1
Drug Prices:see low prices

Pharmacology for Ingredient: icatibant acetate

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Shire Orphan Therap
FIRAZYR
icatibant acetate
INJECTABLE;SUBCUTANEOUS022150-001Aug 25, 2011RXYes► subscribe► subscribe
Shire Orphan Therap
FIRAZYR
icatibant acetate
INJECTABLE;SUBCUTANEOUS022150-001Aug 25, 2011RXYes► subscribe► subscribe
Shire Orphan Therap
FIRAZYR
icatibant acetate
INJECTABLE;SUBCUTANEOUS022150-001Aug 25, 2011RXYes5,648,333► subscribeYY ► subscribe
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International Patent Family for Ingredient: icatibant acetate

Country Document Number Estimated Expiration
South Africa8906068► subscribe
European Patent Office0455133► subscribe
Lithuania1466► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: ICATIBANT ACETATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
/2008Austria► subscribePRODUCT NAME: ICATIBANT, WAHLWEISE IN FORM EINES PHYSIOLOGISCH ANNEHMBAREN SALZES, EINSCHLIESSLICH ICATIBANT-ACETAT; REGISTRATION NO/DATE: EU/1/08/461/001 20080711
0359Netherlands► subscribe300359, 20091121, EXPIRES: 20141120
C0002France► subscribePRODUCT 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
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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.

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