FIRAZYR Drug Patent Profile

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Which patents cover Firazyr, and when can generic versions of Firazyr launch?

Firazyr is a drug marketed by Takeda Pharms Usa and is included in one NDA.

The generic ingredient in FIRAZYR is icatibant acetate. There are thirteen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the icatibant acetate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Firazyr

A generic version of FIRAZYR was approved as icatibant acetate by TEVA PHARMS USA on July 15^th, 2019.

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Summary for FIRAZYR

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	74
Clinical Trials:	9
Patent Applications:	326
Drug Prices:	Drug price information for FIRAZYR
What excipients (inactive ingredients) are in FIRAZYR?	FIRAZYR excipients list
DailyMed Link:	FIRAZYR at DailyMed

Drug patent expirations by year for FIRAZYR

Recent Clinical Trials for FIRAZYR

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Sebastian Videla	Phase 2
Long Beach Memorial Medical Center	Phase 2
University of California, San Francisco	Phase 2

See all FIRAZYR clinical trials

Pharmacology for FIRAZYR

Drug Class	Bradykinin B2 Receptor Antagonist
Mechanism of Action	Bradykinin B2 Receptor Antagonists

Paragraph IV (Patent) Challenges for FIRAZYR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
FIRAZYR	Injection	icatibant acetate	10 mg/mL	022150	2	2015-08-25

US Patents and Regulatory Information for FIRAZYR

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Takeda Pharms Usa	FIRAZYR	icatibant acetate	INJECTABLE;SUBCUTANEOUS	022150-001	Aug 25, 2011	AP	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for FIRAZYR

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	FIRAZYR	icatibant acetate	INJECTABLE;SUBCUTANEOUS	022150-001	Aug 25, 2011	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for FIRAZYR

See the table below for patents covering FIRAZYR around the world.

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Country	Patent Number	Title	Estimated Expiration
Japan	2997519		⤷ Sign Up
Ireland	65356	Peptides having bradykinin antagonist action	⤷ Sign Up
Mexico	9203277	PEPTIDOS CON EFECTO ANTAGONISTA DE LA BRADIQUININA	⤷ Sign Up
Canada	1340667	PEPTIDES EXERCANT UNE ACTION ANTAGONISTE VIS-A-VIS DE LA BRADYKININE (PEPTIDES HAVING BRADYKININ ANTAGONIST ACTION)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for FIRAZYR

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0370453	SPC/GB09/002	United Kingdom	⤷ Sign Up	PRODUCT NAME: ICATIBANT, OR A PHYSIOLOGICALLY TOLERABLE SALT THEREOF, INCLUDING ICATIBANT ACETATE; REGISTERED: UK EU/1/08/461/001 20080711
0370453	51/2008	Austria	⤷ Sign Up	PRODUCT NAME: ICATIBANT, WAHLWEISE IN FORM EINES PHYSIOLOGISCH ANNEHMBAREN SALZES, EINSCHLIESSLICH ICATIBANT-ACETAT; REGISTRATION NO/DATE: EU/1/08/461/001 20080711
0370453	300359	Netherlands	⤷ Sign Up	300359, 20091121, EXPIRES: 20141120
0370453	09C0002	France	⤷ Sign Up	PRODUCT NAME: ICATIBANT, EVENTUELLEMENT SOUS FORME DE SEL PHYSIOLOGIQUEMENT ACCEPTABLE, NOTAMMENT L?ACETATE D?ICATIBANT; REGISTRATION NO/DATE IN FRANCE: EU/1/08/461/001 DU 20080711; REGISTRATION NO/DATE AT EEC: EU/1/08/461/001 DU 20080711
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description