MICAFUNGIN SODIUM - Generic Drug Details

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What are the generic drug sources for micafungin sodium and what is the scope of freedom to operate?

Micafungin sodium is the generic ingredient in four branded drugs marketed by Apotex, Biocon Pharma, Fresenius Kabi Usa, Hikma, Jiangsu Hansoh Pharm, Meitheal, Xellia Pharms Aps, Zydus Pharms, Astellas, Endo Operations, Teva Pharms Usa Inc, and Baxter Hlthcare Corp, and is included in twelve 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.

Summary for MICAFUNGIN SODIUM

US Patents:	0
Tradenames:	4
Applicants:	12
NDAs:	12
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	13
Raw Ingredient (Bulk) Api Vendors:	39
Clinical Trials:	5
Patent Applications:	121
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for MICAFUNGIN SODIUM
What excipients (inactive ingredients) are in MICAFUNGIN SODIUM?	MICAFUNGIN SODIUM excipients list
DailyMed Link:	MICAFUNGIN SODIUM at DailyMed

Recent Clinical Trials for MICAFUNGIN SODIUM

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

Sponsor	Phase
Shandong Provincial Hospital	Phase 4
Astellas Pharma China, Inc.
Seoul National University Hospital	Phase 2

See all MICAFUNGIN SODIUM clinical trials

Generic filers with tentative approvals for MICAFUNGIN SODIUM

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	EQ 100MG BASE/VIAL	INJECTABLE;INTRAVENOUS
⤷ Sign Up	⤷ Sign Up	EQ 50MG BASE/VIAL	INJECTABLE;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

Drug Class	Echinocandin Antifungal

Anatomical Therapeutic Chemical (ATC) Classes for MICAFUNGIN SODIUM

J02AX	Other antimycotics for systemic use
J02A	ANTIMYCOTICS FOR SYSTEMIC USE
J02	ANTIMYCOTICS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

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

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Glossary

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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	216142-003	Sep 29, 2023		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva Pharms Usa Inc	MICAFUNGIN	micafungin sodium	POWDER;INTRAVENOUS	212125-002	Jul 30, 2021		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Apotex	MICAFUNGIN SODIUM	micafungin sodium	INJECTABLE;INTRAVENOUS	208366-002	Nov 5, 2020		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Biocon Pharma	MICAFUNGIN SODIUM	micafungin sodium	INJECTABLE;INTRAVENOUS	216438-001	May 29, 2024	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

Expired US Patents for MICAFUNGIN SODIUM

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astellas	MYCAMINE	micafungin sodium	INJECTABLE;INTRAVENOUS	021506-003	Jun 27, 2006	⤷ Sign Up	⤷ Sign Up
Astellas	MYCAMINE	micafungin sodium	INJECTABLE;INTRAVENOUS	021506-002	Mar 16, 2005	⤷ Sign Up	⤷ Sign Up
Astellas	MYCAMINE	micafungin sodium	INJECTABLE;INTRAVENOUS	021506-003	Jun 27, 2006	⤷ Sign Up	⤷ Sign Up
Astellas	MYCAMINE	micafungin sodium	INJECTABLE;INTRAVENOUS	021506-002	Mar 16, 2005	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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