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MYCAMINE

NDA

MICAFUNGIN SODIUM | N021506 | ASTELLAS PHARMA US INC

2 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Locke Lord LLP FDA-2017-P-6451 · 6 docket documents Locke Lord LLP filed this suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare micafungin sodium for injection 150 mg/vial suitable for submission as part of a single ANDA, with Mycamine (micafungin sodium) for injection as the R	Suitability	2017-11-09	Granted	Locke Lord LLP

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

47 trials from ClinicalTrials.gov, 30 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study to Compare Efficacy and Safety of Mycamine® and Itraconazole for Preventing Fungal Infections NCT00794703	Phase 3	Completed	Astellas Pharma Inc	288	2008-11 → 2009-11
Liver Transplant European Study Into the Prevention of Fungal Infection NCT01058174	Phase 3	Completed	Astellas Pharma Inc	350	2009-12-15 → 2012-05-03
A Clinical Study of MK0991 (Caspofungin) in Japanese Patients With Deep-seated Candida or Aspergillus Infections (0991-062)(COMPLETED)NCT00717860	Phase 3	Completed	Merck Sharp & Dohme LLC	121	2008-08 → 2010-07
An Open-Label Study of the Safety and Pharmacokinetics of Repeated-Dose Micafungin in Neonates NCT00818584	Phase 1	Completed	Astellas Pharma Inc	13	2007-08 → 2007-10
Pharmacokinetics of Micafungin in Children on Extracorporeal Membrane Oxygenation NCT01666769	Phase 1	Completed	Kevin Watt	18	2013-01 → 2016-02-09
Study of Micafungin in Patients With Invasive Candidiasis or Candidemia NCT00105144	Phase 3	Completed	Astellas Pharma Inc	611	2004-09 → 2006-04
Pharmacokinetic Study on Echinocandins for Patients With Septic Shock Following Secondary Peritonitis (EPI Study)NCT02805049	Phase 4	Completed	Centre Hospitalier Universitaire de Nīmes	24	2017-01-28 → 2018-06-18
Study of Mycamine® in Infants and Toddlers With Fungal Infections to Evaluate Safety and Blood Levels of the Drug NCT00607763	Phase 1	Completed	Astellas Pharma Inc	9	2007-10 → 2009-10
Comparison of Candida Eradication and Serum Cidal Activity of Echinocandins NCT00839540	Phase 4	Completed	Gary E. Stein, Pharm.D.	21	2008-12 → 2010-05
Micafungin Pharmacokinetics in Obese Patients NCT03102658	Phase 4	Completed	Radboud University Medical Center	24	2017-01 → 2017-07

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Medicare Part D Spending

CMS annual spending data for Mycamine (2024)

Total Spending

$101K

Total Claims

116

Beneficiaries

Avg Cost/Unit

$55.27

Spending Trend

$8.2M(2019)→$6.2M(2020)→$1.6M(2021)→$616K(2022)→$249K(2023)→$101K(2024)

YoY Change:+304.6%

5yr CAGR:+28.8%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

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 A

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.

Approval Letters

10 letters from Drugs@FDA

Date	Submission	Document
Jan 12, 2021	SUPPL -24	View Letter (PDF)
Dec 26, 2019	SUPPL -23	View Letter (PDF)
Jun 24, 2013	SUPPL -15	View Letter (PDF)
Apr 24, 2013	SUPPL -14	View Letter (PDF)
Jun 10, 2011	SUPPL -12	View Letter (PDF)
Jun 10, 2011	SUPPL -11	View Letter (PDF)
Jan 24, 2008	SUPPL -8	View Letter (PDF)
Aug 7, 2007	SUPPL -9	View Letter (PDF)
Jul 3, 2006	SUPPL -4	View Letter (PDF)
Mar 18, 2005	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

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#002 — EQ 50MG BASE/VIAL

RLD

0 patents0 exclusivities▴

INJECTABLE;INTRAVENOUS | Approved: Mar 16, 2005

No patent or exclusivity listings for this strength.

#003 — EQ 100MG BASE/VIAL

RLD

0 patents0 exclusivities▾

INJECTABLE;INTRAVENOUS | Approved: Jun 27, 2006