Icatibant acetate
Icatibant acetate: 1 brand, 10 generics; first approved Aug 25, 2011; generic available.
Generic available: 10 ANDA applications approved.
Brand (NDA) products
- TAKEDA PHARMS USANDA 0221502011
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) INJECTABLE SUBCUTANEOUS Rx AP
Generic (ANDA) products (10)
- ICATIBANT ACETATEALEMBICANDA 2137732024
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) INJECTABLE SUBCUTANEOUS Rx AP - ICATIBANT ACETATEEUGIA PHARMAANDA 2135212023
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) INJECTABLE SUBCUTANEOUS Rx AP - ICATIBANT ACETATEGLENMARK PHARMS LTDANDA 2132222021
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) INJECTABLE SUBCUTANEOUS Discontinued - - ICATIBANT ACETATENANG KUANG PHARM COANDA 2120812020
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) INJECTABLE SUBCUTANEOUS Rx AP - ICATIBANT ACETATECAPLINANDA 2130542020
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) INJECTABLE SUBCUTANEOUS Discontinued - - ICATIBANT ACETATEWILSHIRE PHARMS INCANDA 2115012020
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) INJECTABLE SUBCUTANEOUS Rx AP - ICATIBANT ACETATECIPLAANDA 2124462020
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) INJECTABLE SUBCUTANEOUS Rx AP - ICATIBANT ACETATEFRESENIUS KABI USAANDA 2083172020
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) INJECTABLE SUBCUTANEOUS Rx AP - ICATIBANT ACETATEJIANGSU HANSOH PHARMANDA 2110212020
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) INJECTABLE SUBCUTANEOUS Rx AP - ICATIBANT ACETATETEVA PHARMS USAANDA 2101182019
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) INJECTABLE SUBCUTANEOUS Rx AP
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
Approvals span 2011–2024 across 11 FDA applications.
Icatibant acetate: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
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