Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 21, 2019

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 thirteen drug master file entries for this compound. Two 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: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 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
Patent:  Start TrialPatent 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:

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Mallinckrodt
Harvard Business School
Colorcon

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