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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Dow
Covington
McKinsey
AstraZeneca
Mallinckrodt
Medtronic
Fuji
Boehringer Ingelheim

Generated: August 21, 2018

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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 seven 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: 7
Suppliers / Packagers: 1
Bulk Api Vendors: 24
Clinical Trials: 4
Patent Applications: 2
DailyMed Link:micafungin sodium at DailyMed
Pharmacology for micafungin sodium
Ingredient-typeLipopeptides
Drug ClassEchinocandin 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;INTRAVENOUS 021506-003 Jun 27, 2006 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Astellas MYCAMINE micafungin sodium INJECTABLE;INTRAVENOUS 021506-002 Mar 16, 2005 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Astellas MYCAMINE micafungin sodium INJECTABLE;INTRAVENOUS 021506-003 Jun 27, 2006 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
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 ➤ Try a Free Trial ➤ Try a Free Trial
Astellas MYCAMINE micafungin sodium INJECTABLE;INTRAVENOUS 021506-002 Mar 16, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Astellas MYCAMINE micafungin sodium INJECTABLE;INTRAVENOUS 021506-003 Jun 27, 2006 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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

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Supplementary Protection Certificates for micafungin sodium

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0028 France ➤ Try a Free Trial PRODUCT NAME: MICAFUNGINE; REGISTRATION NO/DATE: EU/1/08/448/001-002 20080425
C/GB08/036 United Kingdom ➤ Try a Free 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
2008 00030 Denmark ➤ Try a Free Trial
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
McKinsey
Fish and Richardson
Cipla
Medtronic
Boehringer Ingelheim
Covington
Fuji
UBS

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