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Micafungin sodium - Generic Drug Details

What are the generic sources for micafungin sodium and what is the scope of micafungin sodium patent protection?

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.

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

Summary for micafungin sodium

US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	7
Suppliers / Packagers:	1
Bulk Api Vendors:	23
Clinical Trials:	4
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

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Glossary

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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;INTRAVENOUS	021506-002	Mar 16, 2005		RX	Yes	Yes	➤ Sign Up	➤ Sign Up	Y			➤ Sign Up
Astellas	MYCAMINE	micafungin sodium	INJECTABLE;INTRAVENOUS	021506-003	Jun 27, 2006		RX	Yes	Yes	➤ Sign Up	➤ Sign Up	Y			➤ Sign Up
Astellas	MYCAMINE	micafungin sodium	INJECTABLE;INTRAVENOUS	021506-002	Mar 16, 2005		RX	Yes	Yes	➤ Sign Up	➤ Sign Up	Y	Y		➤ Sign Up
Astellas	MYCAMINE	micafungin sodium	INJECTABLE;INTRAVENOUS	021506-003	Jun 27, 2006		RX	Yes	Yes	➤ Sign Up	➤ Sign Up	Y	Y		➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration

Expired US Patents for micafungin sodium

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

International Patents for micafungin sodium

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Country	Document Number	Estimated Expiration
Czech Republic	295720	➤ Sign Up
New Zealand	510290	➤ Sign Up
Germany	69529172	➤ Sign Up
Australia	3578095	➤ Sign Up
Country	Document Number	Estimated Expiration

Supplementary Protection Certificates for micafungin sodium

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Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0352	Netherlands	➤ Sign Up	300352, 20150929, EXPIRES: 20200928
452	Luxembourg	➤ Sign Up	91452, EXPIRES: 20200929
0788511/01	Switzerland	➤ Sign Up	PRODUCT NAME: MICAFUNGIN; REGISTRATION NO/DATE: SWISSMEDIC 60724 11.07.2012
C/GB08/036	United Kingdom	➤ Sign Up	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
Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description