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FDA Orange Book · active-ingredient family

Micafungin sodium

Micafungin sodium is approved as 4 brand and 12 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:MICAFUNGIN IN SODIUM CHLORIDE 0.9% · NDA 216142

4

Brand (NDA)

12

Generics (ANDA)

1

Listed patents

0

Exclusivity periods

Brand (NDA) products · injectable, powder, solution

ProductApplicantApplicationTEApproved
MICAFUNGIN IN SODIUM CHLORIDE 0.9%RLD×3BAXTER HLTHCARE CORPNDA 216142—Sep 29, 2023
MICAFUNGINRLD×2TEVA PHARMS USA INCNDA 212125—Jul 30, 2021
MICAFUNGINRLD×2PH HEALTHNDA 212156—Jun 16, 2021
MYCAMINERLD×2ASTELLASNDA 021506—Mar 16, 2005

Generic (ANDA) products (12)

ProductApplicantApplicationTEApproved
MICAFUNGIN SODIUM×2ASPIROANDA 220296APMar 17, 2026
MICAFUNGIN SODIUM×2YICHANG HUMANWELLANDA 219518APFeb 24, 2026
MICAFUNGIN SODIUM×2HISUN PHARM HANGZHOUANDA 219712APJan 21, 2026
MICAFUNGIN SODIUM×2QILU PHARM HAINANANDA 219273APApr 03, 2025
MICAFUNGIN SODIUM×2BIOCON PHARMAANDA 216438APMay 29, 2024
MICAFUNGIN SODIUM×2ZYDUS PHARMSANDA 215241APOct 24, 2022
MICAFUNGIN SODIUM×2MEITHEALANDA 215381APSep 28, 2022
MICAFUNGIN SODIUM×2HIKMAANDA 213261APJul 09, 2021
MICAFUNGIN SODIUM×2JIANGSU HANSOH PHARMANDA 213363APJul 09, 2021
MICAFUNGIN SODIUM×2XELLIA PHARMS APSANDA 211713APJun 02, 2021
MICAFUNGIN SODIUM×2APOTEXANDA 208366—Nov 05, 2020
MICAFUNGIN SODIUM×2FRESENIUS KABI USAANDA 207344APMay 17, 2019

Listed patents (1)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
12403173Dec 15, 2037in 11 yr 8 mo
Product

Micafungin sodium — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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