Generated: December 12, 2017
DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 022150
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, which is a drug marketed by Shire Orphan Therap and is included in one NDA. It is available from one supplier. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the FIRAZYR profile page.
The generic ingredient in FIRAZYR is icatibant acetate. There are nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the icatibant acetate profile page.
Summary for 022150
Pharmacology for NDA: 022150
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Summary for product number 001
|Active Rx/OTC/Discontinued:||RX||Dosage:||INJECTABLE;SUBCUTANEOUS||Strength||EQ 30MG BASE/3ML (EQ 10MG BASE/ML)|
|Approval Date:||Aug 25, 2011||TE:||RLD:||Yes|
|Regulatory Exclusivity Expiration:||Aug 25, 2016
|Regulatory Exclusivity Use:||NEW CHEMICAL ENTITY|
|Regulatory Exclusivity Expiration:||Aug 25, 2018
|Regulatory Exclusivity Use:||ORPHAN DRUG EXCLUSIVITY|
|Patent:||► Subscribe||Patent Expiration:||Jul 15, 2019||Product Flag?||Y||Substance Flag?||Y||Delist Request?|
|Patented Use:||TREATMENT OF PATHOLOGICAL STATE BY ANTAGONIZING BRADYKININ RECEPTOR INCLUDING TREATMENT OF ACUTE ATTACKS OF HEREDITARY ANGIOEDEMA (HAE)|
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