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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
UBS
Fuji
Chubb
Healthtrust
Queensland Health
Cantor Fitzgerald
Argus Health
US Army
Julphar

Generated: December 12, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022150

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NDA 022150 describes FIRAZYR, 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

Tradename:1
Applicant:1
Ingredient:1
Patents:1

Pharmacology for NDA: 022150

Suppliers and Packaging for NDA: 022150

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FIRAZYR icatibant acetate INJECTABLE;SUBCUTANEOUS 022150 NDA Shire US Manufacturing Inc. 54092-702 54092-702-02 1 SYRINGE, GLASS in 1 CARTON (54092-702-02) > 3 mL in 1 SYRINGE, GLASS
FIRAZYR icatibant acetate INJECTABLE;SUBCUTANEOUS 022150 NDA Shire US Manufacturing Inc. 54092-702 54092-702-03 3 SYRINGE, GLASS in 1 CARTON (54092-702-03) > 3 mL in 1 SYRINGE, GLASS

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrengthEQ 30MG BASE/3ML (EQ 10MG BASE/ML)
Approval Date:Aug 25, 2011TE: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:► SubscribePatent Expiration:Jul 15, 2019Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF PATHOLOGICAL STATE BY ANTAGONIZING BRADYKININ RECEPTOR INCLUDING TREATMENT OF ACUTE ATTACKS OF HEREDITARY ANGIOEDEMA (HAE)


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Serving leading biopharmaceutical companies globally:

McKinsey
Chinese Patent Office
Johnson and Johnson
Farmers Insurance
Merck
Accenture
Deloitte
Novartis
Cerilliant
Federal Trade Commission

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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