FDA Orange Book · active-ingredient family
Micafungin sodium
Micafungin sodium: 4 brands, 12 generics; first approved Mar 16, 2005; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 12 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
4
Generics (ANDA)
12
Listed patents
1
Next patent expiry
Dec 15, 2037
in 11 yr 4 mo
Brand (NDA) products
Originator applications
- BAXTER HLTHCARE CORPNDA 21614220233 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE/50ML (EQ 1MG BASE/ML) SOLUTION INTRAVENOUS Rx - EQ 100MG BASE/100ML (EQ 1MG BASE/ML) SOLUTION INTRAVENOUS Rx - EQ 150MG BASE/150ML (EQ 1MG BASE/ML) SOLUTION INTRAVENOUS Rx - - MICAFUNGINRLDTEVA PHARMS USA INCNDA 21212520212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE/VIAL POWDER INTRAVENOUS Discontinued - EQ 100MG BASE/VIAL POWDER INTRAVENOUS Discontinued - - MICAFUNGINRLDPH HEALTHNDA 21215620212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE/VIAL POWDER INTRAVENOUS Discontinued - EQ 100MG BASE/VIAL POWDER INTRAVENOUS Discontinued - - MYCAMINERLDASTELLASNDA 02150620052 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE/VIAL INJECTABLE INTRAVENOUS Discontinued - EQ 100MG BASE/VIAL INJECTABLE INTRAVENOUS Discontinued -
Generic (ANDA) products (12)
Abbreviated applications
- MICAFUNGIN SODIUMASPIROANDA 22029620262 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE/VIAL INJECTABLE INTRAVENOUS Rx AP EQ 100MG BASE/VIAL INJECTABLE INTRAVENOUS Rx AP - MICAFUNGIN SODIUMYICHANG HUMANWELLANDA 21951820262 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE/VIAL INJECTABLE INTRAVENOUS Rx AP EQ 100MG BASE/VIAL INJECTABLE INTRAVENOUS Rx AP - MICAFUNGIN SODIUMHISUN PHARM HANGZHOUANDA 21971220262 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE/VIAL INJECTABLE INTRAVENOUS Rx AP EQ 100MG BASE/VIAL INJECTABLE INTRAVENOUS Rx AP - MICAFUNGIN SODIUMQILU PHARM HAINANANDA 21927320252 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE/VIAL INJECTABLE INTRAVENOUS Rx AP EQ 100MG BASE/VIAL INJECTABLE INTRAVENOUS Rx AP - MICAFUNGIN SODIUMBIOCON PHARMAANDA 21643820242 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE/VIAL INJECTABLE INTRAVENOUS Rx AP EQ 100MG BASE/VIAL INJECTABLE INTRAVENOUS Rx AP - MICAFUNGIN SODIUMZYDUS PHARMSANDA 21524120222 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE/VIAL INJECTABLE INTRAVENOUS Rx AP EQ 100MG BASE/VIAL INJECTABLE INTRAVENOUS Rx AP - MICAFUNGIN SODIUMMEITHEALANDA 21538120222 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE/VIAL INJECTABLE INTRAVENOUS Rx AP EQ 100MG BASE/VIAL INJECTABLE INTRAVENOUS Rx AP - MICAFUNGIN SODIUMHIKMAANDA 21326120212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE/VIAL INJECTABLE INTRAVENOUS Rx AP EQ 100MG BASE/VIAL INJECTABLE INTRAVENOUS Rx AP - MICAFUNGIN SODIUMJIANGSU HANSOH PHARMANDA 21336320212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE/VIAL INJECTABLE INTRAVENOUS Rx AP EQ 100MG BASE/VIAL INJECTABLE INTRAVENOUS Rx AP - MICAFUNGIN SODIUMXELLIA PHARMS APSANDA 21171320212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE/VIAL INJECTABLE INTRAVENOUS Rx AP EQ 100MG BASE/VIAL INJECTABLE INTRAVENOUS Rx AP - MICAFUNGIN SODIUMAPOTEXANDA 20836620202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE/VIAL INJECTABLE INTRAVENOUS Discontinued - EQ 100MG BASE/VIAL INJECTABLE INTRAVENOUS Discontinued - - MICAFUNGIN SODIUMRSFRESENIUS KABI USAANDA 20734420192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE/VIAL INJECTABLE INTRAVENOUS Rx AP EQ 100MG BASE/VIAL INJECTABLE INTRAVENOUS Rx AP
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 12403173 | in 11 yr 4 mo | Product |
Approval history
FDA approval span
First approval
21 yr 11 mo ago
Most recent approval
7 mo ago
Approvals span 2005–2026 across 16 FDA applications.
Brand (NDA) 425%
Generic (ANDA) 1275%
Micafungin sodium: 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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