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Last Updated: April 18, 2021

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MICAFUNGIN SODIUM Drug Profile

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When do Micafungin Sodium patents expire, and what generic alternatives are available?

Micafungin Sodium is a drug marketed by Apotex and Fresenius Kabi Usa and is included in two NDAs.

The generic ingredient in MICAFUNGIN SODIUM is micafungin sodium. There are eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the micafungin sodium profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Micafungin Sodium

A generic version of MICAFUNGIN SODIUM was approved as micafungin sodium by FRESENIUS KABI USA on May 17th, 2019.

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Drug patent expirations by year for MICAFUNGIN SODIUM
Recent Clinical Trials for MICAFUNGIN SODIUM

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

See all MICAFUNGIN SODIUM clinical trials

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 208366-001 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
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 207344-001 May 17, 2019 AP RX No No   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

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