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MICAFUNGIN SODIUM

ANDA

MICAFUNGIN SODIUM | A211713 | XELLIA PHARMACEUTICALS APS

2 strengths0 unique patents0 unique exclusivities

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Astellas Pharma Inc. et al v. Xellia Pharmaceuticals ApS et al 1:2018cv01818 1 patentANDA 211713micafungin sodium	D. Del.	2018-11-19	Terminated 2019-04-29	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

API Supply Chain12 active DMFs1 inactive

9 active API suppliers hold Drug Master Files for this ingredient.

ZHEJIANG HISUN PHARMACEUTICAL CO LTDMICAFUNGIN SODIUM USP

DMF 274352013

BRIGHTGENE BIO-MEDICAL TECHNOLOGY CO LTDMICAFUNGIN SODIUM INTERMEDIATE MFA

DMF 300282015

MEDICHEM MANUFACTURING (MALTA) LTDMICAFUNGIN SODIUM

DMF 305582016

BIOCON LTDMICAFUNGIN SODIUM

DMF 308802016

BRIGHTGENE BIO-MEDICAL TECHNOLOGY CO LTDMICAFUNGIN SODIUM (NON-STERILE, API)

DMF 314492017

TAPI NL BVMICAFUNGIN SODIUM

DMF 328122018

JIANGSU HANSOH PHARMACEUTICAL GROUP CO LTDMICAFUNGIN SODIUM

DMF 333432018

BRIGHTGENE BIO-MEDICAL TECHNOLOGY CO LTDMICAFUNGIN SODIUM INTERMEDIATE MCB

DMF 338922019

YUNG SHIN PHARMACEUTICAL INDUSTRIAL CO LTDMICAFUNGIN SODIUM "YUNG SHIN"

DMF 348882020

MSN LIFE SCIENCES PRIVATE LTDMICAFUNGIN SODIUM USP

DMF 356572021

JIANGSU HANSOH PHARMACEUTICAL GROUP CO LTDMICAFUNGIN SODIUM

DMF 362962022

HETERO DRUGS LTDMICAFUNGIN SODIUM

DMF 401322024

SHANGHAI TECHWELL BIOPHARMACEUTICAL CO LTDInactiveMICAFUNGIN SODIUM

DMF 296622015

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (2)

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#001 — EQ 50MG BASE/VIAL

0 patents0 exclusivities▴

INJECTABLE;INTRAVENOUS | Approved: Jun 2, 2021

No patent or exclusivity listings for this strength.

#002 — EQ 100MG BASE/VIAL

0 patents0 exclusivities▾

INJECTABLE;INTRAVENOUS | Approved: Jun 2, 2021