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Last Updated: March 19, 2024

Icatibant acetate - Generic Drug Details


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What are the generic sources for icatibant acetate and what is the scope of freedom to operate?

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

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

Summary for icatibant acetate
US Patents:0
Tradenames:2
Applicants:10
NDAs:10
Drug Master File Entries: 13
Finished Product Suppliers / Packagers: 10
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
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
Teva Pharms Usa ICATIBANT ACETATE icatibant acetate INJECTABLE;SUBCUTANEOUS 210118-001 Jul 15, 2019 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Slayback Pharma Llc ICATIBANT ACETATE icatibant acetate INJECTABLE;SUBCUTANEOUS 211501-001 Sep 1, 2020 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Nang Kuang Pharm Co ICATIBANT ACETATE icatibant acetate INJECTABLE;SUBCUTANEOUS 212081-001 Dec 16, 2020 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Cipla ICATIBANT ACETATE icatibant acetate INJECTABLE;SUBCUTANEOUS 212446-001 Jul 13, 2020 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Takeda Pharms Usa FIRAZYR icatibant acetate INJECTABLE;SUBCUTANEOUS 022150-001 Aug 25, 2011 AP RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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