Icatibant acetate - Generic Drug Details

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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, Cipla, Dr Reddys, 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.

There are thirteen drug master file entries for icatibant acetate. Eleven suppliers are listed for this compound.

Summary for icatibant acetate

US Patents:	0
Tradenames:	2
Applicants:	11
NDAs:	11
Drug Master File Entries:	13
Finished Product Suppliers / Packagers:	11
Raw Ingredient (Bulk) Api Vendors:	14
Patent Applications:	39
What excipients (inactive ingredients) are in icatibant acetate?	icatibant acetate excipients list
DailyMed Link:	icatibant acetate at DailyMed

Pharmacology for icatibant acetate

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

Anatomical Therapeutic Chemical (ATC) Classes for icatibant acetate

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 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

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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
Wilshire Pharms Inc	ICATIBANT ACETATE	icatibant acetate	INJECTABLE;SUBCUTANEOUS	211501-001	Sep 1, 2020	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Dr Reddys	ICATIBANT ACETATE	icatibant acetate	INJECTABLE;SUBCUTANEOUS	213054-001	Oct 5, 2020		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Nang Kuang Pharm Co	ICATIBANT ACETATE	icatibant acetate	INJECTABLE;SUBCUTANEOUS	212081-001	Dec 16, 2020	AP	RX	No	No	⤷ 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 icatibant acetate

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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

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