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Serving leading biopharmaceutical companies globally:

Baxter
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Generated: December 18, 2017

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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.

Icatibant acetate has one hundred and fourteen patent family members in thirty-three countries and six supplementary protection certificates in five countries.

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

Summary for icatibant acetate

Pharmacology 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 TherapFIRAZYRicatibant acetateINJECTABLE;SUBCUTANEOUS022150-001Aug 25, 2011RXYesYes► Subscribe► Subscribe► Subscribe
Shire Orphan TherapFIRAZYRicatibant acetateINJECTABLE;SUBCUTANEOUS022150-001Aug 25, 2011RXYesYes► Subscribe► Subscribe► Subscribe
Shire Orphan TherapFIRAZYRicatibant acetateINJECTABLE;SUBCUTANEOUS022150-001Aug 25, 2011RXYesYes► Subscribe► SubscribeYY► Subscribe
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International Patent Family for Ingredient: icatibant acetate

Country Document Number Estimated Expiration
Norway2008016► Subscribe
Ireland892522► Subscribe
Portugal91692► Subscribe
Denmark384089► Subscribe
Lithuania3868► Subscribe
Denmark175344► Subscribe
China1035006► Subscribe
Norway177597► Subscribe
Canada2023194► Subscribe
Norway903545► 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
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
C/GB09/002United Kingdom► SubscribePRODUCT NAME: ICATIBANT, OR A PHYSIOLOGICALLY TOLERABLE SALT THEREOF, INCLUDING ICATIBANT ACETATE; REGISTERED: UK EU/1/08/461/001 20080711
/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
00359Netherlands► SubscribePRODUCT NAME: ICATIBANT, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, BIJ VOORKEUR ICATIBANTACETAAT; REGISTRATION NO/DATE: EU/1/048/461/001 20080711
499Luxembourg► Subscribe91499, EXPIRES: 20141121
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Serving leading biopharmaceutical companies globally:

Medtronic
AstraZeneca
Novartis
Mallinckrodt
Johnson and Johnson
Farmers Insurance
Daiichi Sankyo
Accenture
Covington
Citi

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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