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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 two branded drugs marketed by Apotex, Fresenius Kabi Usa, and Astellas, and is included in three NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Micafungin sodium has forty patent family members in twenty-eight countries.

There are eight drug master file entries for micafungin sodium. Three suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for micafungin sodium

International Patents:	40
US Patents:	1
Tradenames:	2
Applicants:	3
NDAs:	3
Drug Master File Entries:	8
Suppliers / Packagers:	3
Bulk Api Vendors:	28
Clinical Trials:	4
Patent Applications:	2
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
Astellas Pharma China, Inc.	N/A
Seoul National University Hospital	Phase 2
Yonsei University	Phase 2

See all micafungin sodium clinical trials

Generic filers with tentative approvals for MICAFUNGIN SODIUM

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

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
Astellas	MYCAMINE	micafungin sodium	INJECTABLE;INTRAVENOUS	021506-002	Mar 16, 2005	AP	RX	Yes	Yes
Astellas	MYCAMINE	micafungin sodium	INJECTABLE;INTRAVENOUS	021506-002	Mar 16, 2005	AP	RX	Yes	Yes					Y
Astellas	MYCAMINE	micafungin sodium	INJECTABLE;INTRAVENOUS	021506-002	Mar 16, 2005	AP	RX	Yes	Yes
Fresenius Kabi Usa	MICAFUNGIN SODIUM	micafungin sodium	INJECTABLE;INTRAVENOUS	207344-001	May 17, 2019	AP	RX	No	No
Apotex	MICAFUNGIN SODIUM	micafungin sodium	INJECTABLE;INTRAVENOUS	208366-002	Nov 5, 2020	AP	RX	No	No
Fresenius Kabi Usa	MICAFUNGIN SODIUM	micafungin sodium	INJECTABLE;INTRAVENOUS	207344-002	May 17, 2019	AP	RX	No	No

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
Astellas	MYCAMINE	micafungin sodium	INJECTABLE;INTRAVENOUS	021506-003	Jun 27, 2006
Astellas	MYCAMINE	micafungin sodium	INJECTABLE;INTRAVENOUS	021506-003	Jun 27, 2006
Astellas	MYCAMINE	micafungin sodium	INJECTABLE;INTRAVENOUS	021506-002	Mar 16, 2005
Astellas	MYCAMINE	micafungin sodium	INJECTABLE;INTRAVENOUS	021506-003	Jun 27, 2006
Astellas	MYCAMINE	micafungin sodium	INJECTABLE;INTRAVENOUS	021506-002	Mar 16, 2005

International Patents for micafungin sodium

Country	Patent Number	Estimated Expiration
Hungary	0103740
New Zealand	510290
Spain	2225161
Brazil	0006823
Japan	3381722
Portugal	1107777

Supplementary Protection Certificates for micafungin sodium

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0788511	C00788511/01	Switzerland		PRODUCT NAME: MICAFUNGIN; REGISTRATION NO/DATE: SWISSMEDIC 60724 11.07.2012
0788511	SPC/GB08/036	United Kingdom		PRODUCT NAME: MICAFUNGIN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF IN PARTICULAR MICAFUNGIN SODIUM; REGISTERED: UK EU/1/08/448/001 20080425; UK EU/1/08/448/002 20080425
0788511	08C0028	France		PRODUCT NAME: MICAFUNGINE; REGISTRATION NO/DATE: EU/1/08/448/001-002 20080425