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Last Updated: April 17, 2021

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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 patent protection?

Micafungin sodium is the generic ingredient in two branded drugs marketed by Apotex, Fresenius Kabi Usa, and Astellas, and is included in three NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Micafungin sodium has forty patent family members in twenty-eight countries.

There are eight drug master file entries for micafungin sodium. Three suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for micafungin sodium
Recent Clinical Trials for micafungin sodium

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Shandong Provincial HospitalPhase 4
Astellas Pharma China, Inc.N/A
Seoul National University HospitalPhase 2

See all micafungin sodium clinical trials

Generic filers with tentative approvals for MICAFUNGIN SODIUM
Applicant Application No. Strength Dosage Form
  Start Trial  Start TrialEQ 100MG BASE/VIALINJECTABLE;INTRAVENOUS
  Start Trial  Start TrialEQ 50MG BASE/VIALINJECTABLE;INTRAVENOUS
  Start Trial  Start TrialEQ 100MG BASE/VIALINJECTABLE;INTRAVENOUS

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for micafungin sodium
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
Apotex MICAFUNGIN SODIUM micafungin sodium INJECTABLE;INTRAVENOUS 208366-002 Nov 5, 2020 AP RX No No   Start Trial   Start Trial   Start Trial
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 021506-003 Jun 27, 2006 AP RX Yes Yes   Start Trial   Start Trial   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 021506-002 Mar 16, 2005   Start Trial   Start Trial
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
>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 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 08C0028 France   Start Trial PRODUCT NAME: MICAFUNGINE; REGISTRATION NO/DATE: EU/1/08/448/001-002 20080425
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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