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Last Updated: November 24, 2024

MICAFUNGIN SODIUM Drug Patent 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, Biocon Pharma, Fresenius Kabi Usa, Hikma, Jiangsu Hansoh Pharm, Meitheal, Xellia Pharms Aps, and Zydus Pharms. and is included in eight NDAs.

The generic ingredient in MICAFUNGIN SODIUM is micafungin sodium. There are eight drug master file entries for this compound. Thirteen 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.
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 Strength NDA ANDAs Submitted Submissiondate
MYCAMINE For Injection micafungin sodium 50 mg/vial 100 mg/vial 021506 1 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 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hikma MICAFUNGIN SODIUM micafungin sodium INJECTABLE;INTRAVENOUS 213261-001 Jul 9, 2021 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Biocon Pharma MICAFUNGIN SODIUM micafungin sodium INJECTABLE;INTRAVENOUS 216438-002 May 29, 2024 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Meitheal MICAFUNGIN SODIUM micafungin sodium INJECTABLE;INTRAVENOUS 215381-002 Sep 28, 2022 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hikma MICAFUNGIN SODIUM micafungin sodium INJECTABLE;INTRAVENOUS 213261-002 Jul 9, 2021 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Zydus Pharms MICAFUNGIN SODIUM micafungin sodium INJECTABLE;INTRAVENOUS 215241-002 Oct 24, 2022 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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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