FDA Orange Book
Generic for Firazyr
Firazyr contains icatibant acetate. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Firazyr is icatibant acetate. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Firazyr products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, subcutaneous | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) | Marketed (Rx) | AP | 8 | AP |
NDA 022150, held by TAKEDA PHARMACEUTICALS USA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic icatibant acetate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| TEVA PHARMACEUTICALS USA INC | 210118 | AP (A-rated, therapeutically equivalent) | July 15, 2019 | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) |
| JIANGSU HANSOH PHARMACEUTICAL GROUP CO LTD | 211021 | AP (A-rated, therapeutically equivalent) | March 9, 2020 | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) |
| FRESENIUS KABI USA LLC | 208317 | AP (A-rated, therapeutically equivalent) | June 18, 2020 | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) |
| CIPLA LTD | 212446 | AP (A-rated, therapeutically equivalent) | July 13, 2020 | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) |
| WILSHIRE PHARMACEUTICALS INC | 211501 | AP (A-rated, therapeutically equivalent) | September 1, 2020 | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) |
| NANG KUANG PHARMACEUTICAL CO LTD | 212081 | AP (A-rated, therapeutically equivalent) | December 16, 2020 | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) |
| EUGIA PHARMA SPECIALITIES LTD | 213521 | AP (A-rated, therapeutically equivalent) | August 14, 2023 | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) |
| ALEMBIC PHARMACEUTICALS LTD | 213773 | AP (A-rated, therapeutically equivalent) | June 14, 2024 | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) |
Firazyr NDC codes
Questions
Is there a generic for Firazyr?
Yes. The generic name for Firazyr is icatibant acetate. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
What is the generic name for Firazyr?
The active ingredient in Firazyr is icatibant acetate, per the FDA Orange Book.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.