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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 micafungin sodium freedom to operate?

Micafungin sodium is the generic ingredient in one branded drug marketed by Astellas and is included in one NDA. 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 six 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:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	6
Suppliers / Packagers:	1
Bulk Api Vendors:	18
Clinical Trials:	2,473
Patent Applications:	2
DailyMed Link:	micafungin sodium at DailyMed

Pharmacology for micafungin sodium

Ingredient-type	Lipopeptides
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

J-013676

KOOAFHGJVIVFMZ-WZPXRXMFSA-M

MCFG

Micafungin sodium (JAN/USAN)

Micafungin sodium [USAN]

MolPort-028-720-447

MolPort-035-789-689

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

PWAXVQURCGJSNE-WZPXRXMFSA-N

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

sodium Micafungin

UNII-IS1UP79R56

Z1867

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
Astellas	MYCAMINE	micafungin sodium	INJECTABLE;IV (INFUSION)	021506-002	Mar 16, 2005		RX	Yes	Yes			Y
Astellas	MYCAMINE	micafungin sodium	INJECTABLE;IV (INFUSION)	021506-003	Jun 27, 2006		RX	Yes	Yes			Y	Y
Astellas	MYCAMINE	micafungin sodium	INJECTABLE;IV (INFUSION)	021506-002	Mar 16, 2005		RX	Yes	Yes			Y	Y
Astellas	MYCAMINE	micafungin sodium	INJECTABLE;IV (INFUSION)	021506-003	Jun 27, 2006		RX	Yes	Yes			Y

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Expired US Patents for micafungin sodium

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

Non-Orange Book US Patents for micafungin sodium

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
7,112,565	Stabilized pharmaceutical composition in lyophilized form
6,265,536	Cyclic hexapeptides having antibiotic activity

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International Patents for micafungin sodium

Country	Document Number	Estimated Expiration
Poland	346297
Taiwan	562808
Portugal	1107777
South Korea	100454784

Supplementary Protection Certificates for micafungin sodium

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0352	Netherlands		300352, 20150929, EXPIRES: 20200928
452	Luxembourg		91452, EXPIRES: 20200929
C0028	France		PRODUCT NAME: MICAFUNGINE; REGISTRATION NO/DATE: EU/1/08/448/001-002 20080425
2008 00030	Denmark