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Last Updated: March 4, 2024

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 four branded drugs marketed by Apotex, Fresenius Kabi Usa, Hikma, Jiangsu Hansoh Pharm, Meitheal, Xellia Pharms Aps, Zydus Pharms, Astellas, Par Sterile Products, Teva Pharms Usa Inc, and Baxter Hlthcare Corp, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.

There are eight drug master file entries for micafungin sodium. Thirteen 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
⤷  Try a Trial⤷  Try a TrialEQ 100MG BASE/VIALINJECTABLE;INTRAVENOUS
⤷  Try a Trial⤷  Try a TrialEQ 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
Baxter Hlthcare Corp MICAFUNGIN IN SODIUM CHLORIDE 0.9% micafungin sodium SOLUTION;INTRAVENOUS 216142-002 Sep 29, 2023 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Teva Pharms Usa Inc MICAFUNGIN micafungin sodium POWDER;INTRAVENOUS 212125-001 Jul 30, 2021 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Jiangsu Hansoh Pharm MICAFUNGIN SODIUM micafungin sodium INJECTABLE;INTRAVENOUS 213363-001 Jul 9, 2021 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hikma MICAFUNGIN SODIUM micafungin sodium INJECTABLE;INTRAVENOUS 213261-001 Jul 9, 2021 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hikma MICAFUNGIN SODIUM micafungin sodium INJECTABLE;INTRAVENOUS 213261-002 Jul 9, 2021 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Fresenius Kabi Usa MICAFUNGIN SODIUM micafungin sodium INJECTABLE;INTRAVENOUS 207344-001 May 17, 2019 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Apotex MICAFUNGIN SODIUM micafungin sodium INJECTABLE;INTRAVENOUS 208366-002 Nov 5, 2020 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 ⤷  Try a Trial ⤷  Try a Trial
Astellas MYCAMINE micafungin sodium INJECTABLE;INTRAVENOUS 021506-003 Jun 27, 2006 ⤷  Try a Trial ⤷  Try a Trial
Astellas MYCAMINE micafungin sodium INJECTABLE;INTRAVENOUS 021506-003 Jun 27, 2006 ⤷  Try a Trial ⤷  Try a Trial
Astellas MYCAMINE micafungin sodium INJECTABLE;INTRAVENOUS 021506-003 Jun 27, 2006 ⤷  Try a Trial ⤷  Try a Trial
Astellas MYCAMINE micafungin sodium INJECTABLE;INTRAVENOUS 021506-002 Mar 16, 2005 ⤷  Try a Trial ⤷  Try a Trial
Astellas MYCAMINE micafungin sodium INJECTABLE;INTRAVENOUS 021506-002 Mar 16, 2005 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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