Micafungin sodium - Generic Drug Details

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.

Summary for micafungin sodium

US Patents:	0
Tradenames:	3
Applicants:	9
NDAs:	9
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	36
Clinical Trials:	5
Patent Applications:	204
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
		EQ 100MG BASE/VIAL	INJECTABLE;INTRAVENOUS
		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

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
Teva Pharms Usa Inc	MICAFUNGIN	micafungin sodium	POWDER;INTRAVENOUS	212125-001	Jul 30, 2021		DISCN	Yes	No
Apotex	MICAFUNGIN SODIUM	micafungin sodium	INJECTABLE;INTRAVENOUS	208366-001	Nov 5, 2020	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	021506-003	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