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Last Updated: November 18, 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 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.

Recent Clinical Trials for micafungin sodium

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SponsorPhase
Astellas Pharma China, Inc.N/A
Seoul National University HospitalPhase 2
Yonsei UniversityPhase 2

See all micafungin sodium clinical trials

Recent Litigation for micafungin sodium

Identify potential future generic entrants

District Court Litigation
Case NameDate
Astellas Pharma Inc. v. Xellia Pharmaceuticals ApS2018-11-19

See all micafungin sodium litigation

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
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   Start Trial   Start Trial   Start Trial
Astellas MYCAMINE micafungin sodium INJECTABLE;INTRAVENOUS 021506-002 Mar 16, 2005 AP RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Astellas MYCAMINE micafungin sodium INJECTABLE;INTRAVENOUS 021506-003 Jun 27, 2006 AP RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Astellas MYCAMINE micafungin sodium INJECTABLE;INTRAVENOUS 021506-002 Mar 16, 2005 AP RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
>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

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

Supplementary Protection Certificates for micafungin sodium

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0788511 91452 Luxembourg   Start Trial 91452, EXPIRES: 20200929
0788511 SPC/GB08/036 United Kingdom   Start Trial 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   Start Trial 300352, 20150929, EXPIRES: 20200928
0788511 C00788511/01 Switzerland   Start Trial PRODUCT NAME: MICAFUNGIN; REGISTRATION NO/DATE: SWISSMEDIC 60724 11.07.2012
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Boehringer Ingelheim
Baxter
Express Scripts
Moodys

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.