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Generated: June 25, 2019

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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 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.

Pharmacology for MICAFUNGIN SODIUM
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

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;INTRAVENOUS 021506-003 Jun 27, 2006 AP RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Astellas MYCAMINE micafungin sodium INJECTABLE;INTRAVENOUS 021506-003 Jun 27, 2006 AP RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Fresenius Kabi Usa MICAFUNGIN SODIUM micafungin sodium INJECTABLE;INTRAVENOUS 207344-002 May 17, 2019 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Astellas MYCAMINE micafungin sodium INJECTABLE;INTRAVENOUS 021506-002 Mar 16, 2005 AP RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Astellas MYCAMINE micafungin sodium INJECTABLE;INTRAVENOUS 021506-002 Mar 16, 2005 AP RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Fresenius Kabi Usa MICAFUNGIN SODIUM micafungin sodium INJECTABLE;INTRAVENOUS 207344-001 May 17, 2019 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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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;INTRAVENOUS 021506-003 Jun 27, 2006 ➤ 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 021506-002 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
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Supplementary Protection Certificates for MICAFUNGIN SODIUM

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0788511 C00788511/01 Switzerland ➤ Sign Up PRODUCT NAME: MICAFUNGIN; REGISTRATION NO/DATE: SWISSMEDIC 60724 11.07.2012
0788511 91452 Luxembourg ➤ Sign Up 91452, EXPIRES: 20200929
0788511 08C0028 France ➤ Sign Up PRODUCT NAME: MICAFUNGINE; REGISTRATION NO/DATE: EU/1/08/448/001-002 20080425
0788511 300352 Netherlands ➤ Sign Up 300352, 20150929, EXPIRES: 20200928
0788511 SPC022/2008 Ireland ➤ Sign Up SPC022/2008: 20090219, EXPIRES: 20200928
0788511 CA 2008 00030 Denmark ➤ Sign Up
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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