FDA Orange Book · active-ingredient family
Icatibant acetate
Icatibant acetate is approved as 1 brand and 10 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:FIRAZYR · NDA 022150
1
Brand (NDA)
10
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| FIRAZYRRLD | TAKEDA PHARMS USA | NDA 022150 | AP | Aug 25, 2011 |
Generic (ANDA) products (10)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ICATIBANT ACETATE | ALEMBIC | ANDA 213773 | AP | Jun 14, 2024 | |
| ICATIBANT ACETATE | EUGIA PHARMA | ANDA 213521 | AP | Aug 14, 2023 | |
| ICATIBANT ACETATE | GLENMARK PHARMS LTD | ANDA 213222 | — | May 21, 2021 | |
| ICATIBANT ACETATE | NANG KUANG PHARM CO | ANDA 212081 | AP | Dec 16, 2020 | |
| ICATIBANT ACETATE | CAPLIN | ANDA 213054 | — | Oct 05, 2020 | |
| ICATIBANT ACETATE | WILSHIRE PHARMS INC | ANDA 211501 | AP | Sep 01, 2020 | |
| ICATIBANT ACETATE | CIPLA | ANDA 212446 | AP | Jul 13, 2020 | |
| ICATIBANT ACETATE | FRESENIUS KABI USA | ANDA 208317 | AP | Jun 18, 2020 | |
| ICATIBANT ACETATE | JIANGSU HANSOH PHARM | ANDA 211021 | AP | Mar 09, 2020 | |
| ICATIBANT ACETATE | TEVA PHARMS USA | ANDA 210118 | AP | Jul 15, 2019 |
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.
Icatibant acetate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
