Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Teva
Mallinckrodt
McKesson
Merck
Baxter
Cerilliant
Citi
McKinsey
US Army

Generated: July 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022150

« Back to Dashboard

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 twelve 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:FIRAZYR
Applicant:Shire Orphan Therap
Ingredient:icatibant acetate
Patents:1
Generic Entry Opportunity Date for 022150
Generic Entry Date for 022150*:
Constraining patent/regulatory exclusivity:
Dosage::
INJECTABLE;SUBCUTANEOUS

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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 N 54092-702-01
FIRAZYR icatibant acetate INJECTABLE;SUBCUTANEOUS 022150 NDA Shire US Manufacturing Inc. 54092-702 N 54092-702-02

Profile 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, 2018
Regulatory Exclusivity Use:TREATMENT OF ACUTE ATTACKS OF HEREDITARY ANGIOEDEMA IN ADULTS 18 YEARS OF AGE AND OLDER
Patent:➤ Sign UpPatent 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)

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

UBS
McKinsey
Colorcon
Farmers Insurance
Daiichi Sankyo
Moodys
Healthtrust
QuintilesIMS
Merck

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.