➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Harvard Business School
McKinsey
Dow
Baxter
Mallinckrodt
Express Scripts

Last Updated: July 5, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022150


Email this page to a colleague

» See Plans and Pricing

« 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. Additional details are available on the FIRAZYR profile page.

The generic ingredient in FIRAZYR is icatibant acetate. There are thirteen drug master file entries for this compound. Three suppliers are 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:0
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 AUTHORIZED GENERIC Shire US Manufacturing Inc. 54092-135 54092-135-01 1 SYRINGE, GLASS in 1 CARTON (54092-135-01) > 3 mL in 1 SYRINGE, GLASS
FIRAZYR icatibant acetate INJECTABLE;SUBCUTANEOUS 022150 NDA AUTHORIZED GENERIC Shire US Manufacturing Inc. 54092-135 54092-135-02 3 SYRINGE, GLASS in 1 CARTON (54092-135-02) > 3 mL in 1 SYRINGE, GLASS
Paragraph IV (Patent) Challenges for 022150
Tradename Dosage Ingredient NDA Submissiondate
FIRAZYR INJECTABLE;SUBCUTANEOUS icatibant acetate 022150 2015-08-25

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrengthEQ 30MG BASE/3ML (EQ 10MG BASE/ML)
Approval Date:Aug 25, 2011TE:APRLD:Yes

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

AstraZeneca
Boehringer Ingelheim
McKinsey
Mallinckrodt
Moodys
Baxter

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 verification 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.