FIRAZYR Drug Patent Profile

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.

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:	417
Drug Prices:	Drug price information for FIRAZYR
What excipients (inactive ingredients) are in FIRAZYR?	FIRAZYR excipients list
DailyMed Link:	FIRAZYR at DailyMed

See drug prices for FIRAZYR

Recent Clinical Trials for FIRAZYR

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

Sponsor	Phase
Sebastian Videla	Phase 2
Emory University	Phase 2
Sanford Health	Phase 2

See all FIRAZYR clinical trials

Pharmacology for FIRAZYR

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

Anatomical Therapeutic Chemical (ATC) Classes for FIRAZYR

B06AC	Drugs used in hereditary angioedema
B06A	OTHER HEMATOLOGICAL AGENTS
B06	OTHER HEMATOLOGICAL AGENTS
B	Blood and blood forming organs

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

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

Expired US Patents for FIRAZYR

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

International Patents for FIRAZYR

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

Country	Patent Number	Title	Estimated Expiration
Norway	911649
Norway	177597
South Africa	9006381
Lithuania	1466
Israel	95357	Peptides having bradykinin antagonist action their preparation and pharmaceutical compositions containing them

Supplementary Protection Certificates for FIRAZYR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0370453	91499	Luxembourg		91499, EXPIRES: 20141121
0370453	09C0002	France		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
0370453	SPC/GB09/002	United Kingdom		PRODUCT NAME: ICATIBANT, OR A PHYSIOLOGICALLY TOLERABLE SALT THEREOF, INCLUDING ICATIBANT ACETATE; REGISTERED: UK EU/1/08/461/001 20080711
0370453	C300359	Netherlands		PRODUCT NAME: ICATIBANT, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, BIJ VOORKEUR ICATIBANTACETAAT; REGISTRATION NO/DATE: EU/1/048/461/001 20080711
0370453	51/2008	Austria		PRODUCT NAME: ICATIBANT, WAHLWEISE IN FORM EINES PHYSIOLOGISCH ANNEHMBAREN SALZES, EINSCHLIESSLICH ICATIBANT-ACETAT; REGISTRATION NO/DATE: EU/1/08/461/001 20080711