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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
Deloitte
Accenture
Daiichi Sankyo
US Army
QuintilesIMS
Julphar
Cerilliant
Boehringer Ingelheim

Generated: May 23, 2018

DrugPatentWatch Database Preview

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-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;IV (INFUSION) 021506-002 Mar 16, 2005 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Astellas MYCAMINE micafungin sodium INJECTABLE;IV (INFUSION) 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;IV (INFUSION) 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;IV (INFUSION) 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;IV (INFUSION) 021506-002 Mar 16, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Astellas MYCAMINE micafungin sodium INJECTABLE;IV (INFUSION) 021506-003 Jun 27, 2006 ➤ Try a Free Trial ➤ Try a Free Trial
Astellas MYCAMINE micafungin sodium INJECTABLE;IV (INFUSION) 021506-002 Mar 16, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Astellas MYCAMINE micafungin sodium INJECTABLE;IV (INFUSION) 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
7,112,565 Stabilized pharmaceutical composition in lyophilized form ➤ Try a Free Trial
6,265,536 Cyclic hexapeptides having antibiotic activity ➤ 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
0352 Netherlands ➤ Try a Free Trial 300352, 20150929, EXPIRES: 20200928
452 Luxembourg ➤ Try a Free Trial 91452, EXPIRES: 20200929
C0028 France ➤ Try a Free Trial PRODUCT NAME: MICAFUNGINE; REGISTRATION NO/DATE: EU/1/08/448/001-002 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:

Express Scripts
Citi
Farmers Insurance
Argus Health
UBS
Deloitte
Chinese Patent Office
Daiichi Sankyo
Mallinckrodt

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.