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Last Updated: November 29, 2022

Micafungin sodium - Generic Drug Details


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What are the generic sources for micafungin sodium and what is the scope of patent protection?

Micafungin sodium is the generic ingredient in three branded drugs marketed by Apotex, Fresenius Kabi Usa, Hikma, Jiangsu Hansoh Pharm, Nanjing King-friend, Xellia Pharms Aps, Astellas, Par Sterile Products, and Teva Pharms Usa Inc, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.

There are eight drug master file entries for micafungin sodium. Seven suppliers are listed for this compound. There is one tentative approval for this compound.

Recent Clinical Trials for micafungin sodium

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

SponsorPhase
Shandong Provincial HospitalPhase 4
Astellas Pharma China, Inc.
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
See Plans and PricingSee Plans and PricingEQ 100MG BASE/VIALINJECTABLE;INTRAVENOUS
See Plans and PricingSee Plans and PricingEQ 50MG 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 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
Astellas MYCAMINE micafungin sodium INJECTABLE;INTRAVENOUS 021506-003 Jun 27, 2006 AP RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Teva Pharms Usa Inc MICAFUNGIN micafungin sodium POWDER;INTRAVENOUS 212125-001 Jul 30, 2021 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Apotex MICAFUNGIN SODIUM micafungin sodium INJECTABLE;INTRAVENOUS 208366-001 Nov 5, 2020 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 021506-003 Jun 27, 2006 See Plans and Pricing See Plans and Pricing
Astellas MYCAMINE micafungin sodium INJECTABLE;INTRAVENOUS 021506-003 Jun 27, 2006 See Plans and Pricing See Plans and Pricing
Astellas MYCAMINE micafungin sodium INJECTABLE;INTRAVENOUS 021506-002 Mar 16, 2005 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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