Home / Generic availability / Icatibant
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.
Approved products
| Product | Type | Applicant | Approved | |
|---|---|---|---|---|
| FIRAZYR | Brand (NDA) | TAKEDA PHARMACEUTICALS USA INC | 2011-08-25 | reference listed drug, reference standard |
| ICATIBANT ACETATE | Generic (ANDA) | FRESENIUS KABI USA LLC | 2020-06-18 | |
| ICATIBANT ACETATE | Generic (ANDA) | TEVA PHARMACEUTICALS USA INC | 2019-07-15 | |
| ICATIBANT ACETATE | Generic (ANDA) | JIANGSU HANSOH PHARMACEUTICAL GROUP CO LTD | 2020-03-09 | |
| ICATIBANT ACETATE | Generic (ANDA) | WILSHIRE PHARMACEUTICALS INC | 2020-09-01 | |
| ICATIBANT ACETATE | Generic (ANDA) | NANG KUANG PHARMACEUTICAL CO LTD | 2020-12-16 | |
| ICATIBANT ACETATE | Generic (ANDA) | CIPLA LTD | 2020-07-13 | |
| ICATIBANT ACETATE | Generic (ANDA) | CAPLIN STERILES LTD | 2020-10-05 | |
| ICATIBANT ACETATE | Generic (ANDA) | GLENMARK PHARMACEUTICALS LTD | 2021-05-21 | |
| ICATIBANT ACETATE | Generic (ANDA) | EUGIA PHARMA SPECIALITIES LTD | 2023-08-14 | |
| ICATIBANT ACETATE | Generic (ANDA) | ALEMBIC PHARMACEUTICALS LTD | 2024-06-14 |
What a generic Icatibant would have to match
Forms and strengths
Icatibant injection is supplied in a prefilled syringe delivering 30 mg icatibant. Each syringe delivers 3 mL solution with a concentration of 10 mg per mL. Injection: 10 mg per mL
How it is supplied
16.1 How Supplied Icatibant injection is supplied as a sterile, clear colorless solution in single-dose, prefilled syringe for subcutaneous administration. Each syringe delivers 3 mL of a sterile solution of icatibant 30 mg (as icatibant acetate). Each glass syringe has a bromobutyl plunger stopper, which is not made of latex natural rubber. Icatibant injection is available in cartons containing one single-dose, prefilled syringe and one 25 G Luer lock needle. NDC 46708-654-03. Icatibant injection is also available in a pack containing 3 cartons; each carton contains one single-dose, prefilled syringe and one 25 G Luer lock needle. NDC 46708-654-09. 16.2 Storage and Handling Keep out of the...
A generic has to match the reference product on active ingredient, strength, dosage form and route. These are the forms the FDA label currently lists. Source: FDA Structured Product Labeling, label effective 2025-06-27.
Other drugs and when their protection ends
Ordered by the date the last listed patent or exclusivity expires.
- Oxytocinno patent or exclusivity listed
- Pramlintideno patent or exclusivity listed
- Secretinno patent or exclusivity listed
- Teduglutideno patent or exclusivity listed
- Teriparatideno patent or exclusivity listed
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 2026-11-01. 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.
Related data
- Icatibant clinical trials →Registered studies, phases and status
- Which peptides are FDA-approved →Approval status for every peptide, from Drugs@FDA
- FDA drug shortage tracker →Which peptide drugs are in shortage now, with the FDA-stated cause
- When peptide drugs go generic →Patent and exclusivity expiry dates from the FDA Orange Book