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Micafungin sodium - Generic Drug Details

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What are the generic drug sources for micafungin sodium and what is the scope of freedom to operate?

Micafungin sodium is the generic ingredient in two branded drugs marketed by Fresenius Kabi Usa and Astellas, and is included in two NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Micafungin sodium has seventy-nine patent family members in thirty-two countries.

There are eight drug master file entries for micafungin sodium. One supplier is listed for this compound.

Summary for micafungin sodium

International Patents:	79
US Patents:	2
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	8
Suppliers / Packagers:	1
Bulk Api Vendors:	23
Clinical Trials:	4
Patent Applications:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for micafungin sodium
DailyMed Link:	micafungin sodium at DailyMed

Recent Clinical Trials for micafungin sodium

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Astellas Pharma China, Inc.	N/A
Seoul National University Hospital	Phase 2
Yonsei University	Phase 2

See all micafungin sodium clinical trials

Recent Litigation for micafungin sodium

Identify potential future generic entrants

District Court Litigation

Case Name	Date
Astellas Pharma Inc. v. Xellia Pharmaceuticals ApS	2018-11-19

See all micafungin sodium litigation

Pharmacology for micafungin sodium

Drug Class

Echinocandin Antifungal

Synonyms for micafungin sodium

208538-73-2

AKOS027461043

C15819

C56H70N9NaO23S

CHEBI:80105

CHEMBL1237070

D02465

FK 463

FK-463

FK463

FK463 Sodium

FT-0687494

Funguard

Funguard (TN)

IS1UP79R56

KOOAFHGJVIVFMZ-WZPXRXMFSA-M

MCFG

Micafungin

Micafungin sodium (JAN/USAN)

Micafungin sodium [USAN]

MolPort-028-720-447

MolPort-035-789-689

Mycamine

Mycamine (TN)

oxo-9-(4-(5-(4-(pentyloxy)phenyl)isoxazol-3-yl)benzamido)tetracosahydro-1H-dipyrrolo[2,1-c:2',1'-l][1,4,7,10,13,16]hexaazacyclohenicosin-23-yl)-1,2-dihydroxyethyl)-2-hydroxyphenyl sulfate

Pneumocandin A0, 1-((4R,5R)-4,5-dihydroxy-N2-(4-(5-(5-(pentyloxy)phenyl)-3-isoxazolyl)benzoyl)-L-ornithine)-4-((4S)-4-hydroxy-4-(4-hydroxy-3-(sulfooxy)phenyl)-L-threonine)-, monosodium salt

Pneumocandin A0, 1-(4R,5R)-4,5-ihydroxy-2-4-5-4-(pentyloxy)henyl]-3-soxazolyl]enzoyl]--rnithine]-4-(4S)-4-ydroxy-4-4-ydroxy-3-(sulfooxy)henyl]

s4287

sodium 5-((1S,2S)-2-((2R,6S,9S,11R,12R,14aS,15S,16S,20S,23S,25aS)-20-((R)-3-amino-1-hydroxy-3-oxopropyl)-2,11,12,15-tetrahydroxy-6-((R)-1-hydroxyethyl)-16-methyl-5,8,14,19,22,25-hexa

UNII-IS1UP79R56

Z1867

Paragraph IV (Patent) Challenges for MICAFUNGIN SODIUM

Tradename	Dosage	Ingredient	NDA	Submissiondate
MYCAMINE	INJECTABLE;INTRAVENOUS	micafungin sodium	021506	2014-06-16

US Patents and Regulatory Information for micafungin sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Fresenius Kabi Usa	MICAFUNGIN SODIUM	micafungin sodium	INJECTABLE;INTRAVENOUS	207344-002	May 17, 2019	AP	RX	No	No
Astellas	MYCAMINE	micafungin sodium	INJECTABLE;INTRAVENOUS	021506-002	Mar 16, 2005	AP	RX	Yes	Yes			Y
Astellas	MYCAMINE	micafungin sodium	INJECTABLE;INTRAVENOUS	021506-003	Jun 27, 2006	AP	RX	Yes	Yes			Y
Astellas	MYCAMINE	micafungin sodium	INJECTABLE;INTRAVENOUS	021506-002	Mar 16, 2005	AP	RX	Yes	Yes			Y	Y

Expired US Patents for micafungin sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astellas	MYCAMINE	micafungin sodium	INJECTABLE;INTRAVENOUS	021506-003	Jun 27, 2006
Astellas	MYCAMINE	micafungin sodium	INJECTABLE;INTRAVENOUS	021506-002	Mar 16, 2005
Astellas	MYCAMINE	micafungin sodium	INJECTABLE;INTRAVENOUS	021506-002	Mar 16, 2005
Astellas	MYCAMINE	micafungin sodium	INJECTABLE;INTRAVENOUS	021506-003	Jun 27, 2006

International Patents for micafungin sodium

Country	Patent Number	Estimated Expiration
Spain	2187575
United Kingdom	9508745
Mexico	PA01000601
Hungary	T77736

Supplementary Protection Certificates for micafungin sodium

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0788511	91452	Luxembourg		91452, EXPIRES: 20200929
0788511	SPC/GB08/036	United Kingdom		PRODUCT NAME: MICAFUNGIN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF IN PARTICULAR MICAFUNGIN SODIUM; REGISTERED: UK EU/1/08/448/001 20080425; UK EU/1/08/448/002 20080425
0788511	300352	Netherlands		300352, 20150929, EXPIRES: 20200928
0788511	C00788511/01	Switzerland		PRODUCT NAME: MICAFUNGIN; REGISTRATION NO/DATE: SWISSMEDIC 60724 11.07.2012