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Home / Generic availability / Icatibant

FDA Orange Book · updated 2026-09-23

When will generic Icatibant be available?

No patents or exclusivity listed

The FDA lists no patents or exclusivity for icatibant, and 10 generic applications are already approved, so generic icatibant is available in the United States.

None
No protection listed
0
Patents listed
0
Exclusivity records
0
Generics waiting

Approved products

ProductTypeApplicantApproved
FIRAZYRBrand (NDA)TAKEDA PHARMACEUTICALS USA INC2011-08-25reference listed drug, reference standard
ICATIBANT ACETATEGeneric (ANDA)FRESENIUS KABI USA LLC2020-06-18
ICATIBANT ACETATEGeneric (ANDA)TEVA PHARMACEUTICALS USA INC2019-07-15
ICATIBANT ACETATEGeneric (ANDA)JIANGSU HANSOH PHARMACEUTICAL GROUP CO LTD2020-03-09
ICATIBANT ACETATEGeneric (ANDA)WILSHIRE PHARMACEUTICALS INC2020-09-01
ICATIBANT ACETATEGeneric (ANDA)NANG KUANG PHARMACEUTICAL CO LTD2020-12-16
ICATIBANT ACETATEGeneric (ANDA)CIPLA LTD2020-07-13
ICATIBANT ACETATEGeneric (ANDA)CAPLIN STERILES LTD2020-10-05
ICATIBANT ACETATEGeneric (ANDA)GLENMARK PHARMACEUTICALS LTD2021-05-21
ICATIBANT ACETATEGeneric (ANDA)EUGIA PHARMA SPECIALITIES LTD2023-08-14
ICATIBANT ACETATEGeneric (ANDA)ALEMBIC PHARMACEUTICALS LTD2024-06-14
How to read these dates. They come from the FDA Orange Book, which records the patents a brand has listed and the exclusivity the FDA has granted. The date shown is when the last of those expires. It is an upper bound on protection, not a prediction of when a generic will actually reach pharmacies.

Frequently asked questions

When will generic Icatibant be available?

The FDA lists no patents or exclusivity for icatibant, and 10 generic applications are already approved, so generic icatibant is available in the United States.

Does this date guarantee a generic launches then?

No. It is the date the last protection the FDA currently lists expires. Patents can be challenged, licensed, or designed around, which can bring a generic earlier, and new patents can be listed later. Treat it as the outer limit of the brand's protection, not a launch forecast.

What is the difference between a patent and exclusivity?

A patent is granted by the patent office and listed with the FDA by the brand. Exclusivity is granted by the FDA itself on approval. They run independently, and exclusivity can keep a generic off the market even after a patent has expired.

What is a tentative approval?

It means the FDA has reviewed a generic application and judged it acceptable, but cannot allow it to be marketed yet because patents or exclusivity are still running. It is the clearest signal that a generic is ready to launch once the dates clear.

Source: FDA Orange Book via openFDA, with tentative-approval data from Drugs@FDA. Last updated 2026-09-23. Do not rely on this page to make decisions regarding medical care; always speak to your health provider about the risks and benefits of FDA-regulated products.