icatibant acetate - Profile

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What are the generic drug sources for icatibant acetate and what is the scope of patent protection?

Icatibant acetate is the generic ingredient in two branded drugs marketed by Takeda Pharms Usa, Alembic, Caplin, Cipla, Eugia Pharma, Fresenius Kabi Usa, Glenmark Pharms Ltd, Jiangsu Hansoh Pharm, Nang Kuang Pharm Co, Teva Pharms Usa, and Wilshire Pharms Inc, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.

Summary for icatibant acetate

US Patents:	0
Tradenames:	2
Applicants:	11
NDAs:	11

Paragraph IV (Patent) Challenges for ICATIBANT ACETATE

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 icatibant acetate

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
Alembic	ICATIBANT ACETATE	icatibant acetate	INJECTABLE;SUBCUTANEOUS	213773-001	Jun 14, 2024	AP	RX	No	No
Caplin	ICATIBANT ACETATE	icatibant acetate	INJECTABLE;SUBCUTANEOUS	213054-001	Oct 5, 2020		DISCN	No	No
Cipla	ICATIBANT ACETATE	icatibant acetate	INJECTABLE;SUBCUTANEOUS	212446-001	Jul 13, 2020	AP	RX	No	No
Eugia Pharma	ICATIBANT ACETATE	icatibant acetate	INJECTABLE;SUBCUTANEOUS	213521-001	Aug 14, 2023	AP	RX	No	No
Fresenius Kabi Usa	ICATIBANT ACETATE	icatibant acetate	INJECTABLE;SUBCUTANEOUS	208317-001	Jun 18, 2020	AP	RX	No	No

Expired US Patents for icatibant acetate

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	5,648,333