FDA Orange Book
Generic for Mycamine
Mycamine contains micafungin. 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 Mycamine is micafungin. 11 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Mycamine products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, intravenous | EQ 100MG BASE/VIAL | Discontinued | None | 11 | AP |
| injectable, intravenous | EQ 50MG BASE/VIAL | Discontinued | None | 11 | AP |
NDA 021506, held by ASTELLAS PHARMA US INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic micafungin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| FRESENIUS KABI USA LLC | 207344 | AP (A-rated, therapeutically equivalent) | May 17, 2019 | EQ 100MG BASE/VIAL, EQ 50MG BASE/VIAL |
| XELLIA PHARMACEUTICALS APS | 211713 | AP (A-rated, therapeutically equivalent) | June 2, 2021 | EQ 100MG BASE/VIAL, EQ 50MG BASE/VIAL |
| HIKMA PHARMACEUTICALS INTERNATIONAL LTD | 213261 | AP (A-rated, therapeutically equivalent) | July 9, 2021 | EQ 100MG BASE/VIAL, EQ 50MG BASE/VIAL |
| JIANGSU HANSOH PHARMACEUTICAL GROUP CO LTD | 213363 | AP (A-rated, therapeutically equivalent) | July 9, 2021 | EQ 100MG BASE/VIAL, EQ 50MG BASE/VIAL |
| MEITHEAL PHARMACEUTICALS INC | 215381 | AP (A-rated, therapeutically equivalent) | September 28, 2022 | EQ 100MG BASE/VIAL, EQ 50MG BASE/VIAL |
| ZYDUS PHARMACEUTICALS USA INC | 215241 | AP (A-rated, therapeutically equivalent) | October 24, 2022 | EQ 100MG BASE/VIAL, EQ 50MG BASE/VIAL |
| BIOCON PHARMA LTD | 216438 | AP (A-rated, therapeutically equivalent) | May 29, 2024 | EQ 100MG BASE/VIAL, EQ 50MG BASE/VIAL |
| QILU PHARMACEUTICAL HAINAN CO LTD | 219273 | AP (A-rated, therapeutically equivalent) | April 3, 2025 | EQ 100MG BASE/VIAL, EQ 50MG BASE/VIAL |
| HISUN PHARMACEUTICAL (HANGZHOU) CO LTD | 219712 | AP (A-rated, therapeutically equivalent) | January 21, 2026 | EQ 100MG BASE/VIAL, EQ 50MG BASE/VIAL |
| YICHANG HUMANWELL PHARMACEUTICAL CO LTD | 219518 | AP (A-rated, therapeutically equivalent) | February 24, 2026 | EQ 100MG BASE/VIAL, EQ 50MG BASE/VIAL |
| ASPIRO PHARMA LTD | 220296 | AP (A-rated, therapeutically equivalent) | March 17, 2026 | EQ 100MG BASE/VIAL, EQ 50MG BASE/VIAL |
Questions
Is there a generic for Mycamine?
Yes. The generic name for Mycamine is micafungin. 11 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 Mycamine?
The active ingredient in Mycamine is micafungin, 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.