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ERAXIS Drug Profile

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When do Eraxis patents expire, and when can generic versions of Eraxis launch?

Eraxis is a drug marketed by Vicuron and is included in one NDA. There are three patents protecting this drug.

This drug has sixty-seven patent family members in twenty-nine countries.

The generic ingredient in ERAXIS is anidulafungin. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the anidulafungin profile page.

US ANDA Litigation and Generic Entry Outlook for Eraxis

Eraxis was eligible for patent challenges on February 17, 2010.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 22, 2023. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for ERAXIS

International Patents:	67
US Patents:	3
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	38
Clinical Trials:	11
Patent Applications:	3,105
Drug Prices:	Drug price information for ERAXIS
DailyMed Link:	ERAXIS at DailyMed

See drug prices for ERAXIS

Generic Entry Opportunity Date for ERAXIS

Constraining patent/regulatory exclusivity:

NEW PATIENT POPULATION

NDA:

021632

Dosage:

POWDER;INTRAVENOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for ERAXIS

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

Sponsor	Phase
University of Texas Southwestern Medical Center	Phase 4
Texas Tech University Health Sciences Center	Phase 4
National Center for Research Resources (NCRR)	Phase 4

See all ERAXIS clinical trials

Pharmacology for ERAXIS

Drug Class

Echinocandin Antifungal

US Patents and Regulatory Information for ERAXIS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Vicuron	ERAXIS	anidulafungin	POWDER;INTRAVENOUS	021632-001	Feb 17, 2006		RX	Yes	Yes			Y	Y
Vicuron	ERAXIS	anidulafungin	POWDER;INTRAVENOUS	021632-002	Nov 14, 2006		RX	Yes	Yes			Y
Vicuron	ERAXIS	anidulafungin	POWDER;INTRAVENOUS	021632-001	Feb 17, 2006		RX	Yes	Yes
Vicuron	ERAXIS	anidulafungin	POWDER;INTRAVENOUS	021632-002	Nov 14, 2006		RX	Yes	Yes

Expired US Patents for ERAXIS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Vicuron	ERAXIS	anidulafungin	POWDER;INTRAVENOUS	021632-002	Nov 14, 2006
Vicuron	ERAXIS	anidulafungin	POWDER;INTRAVENOUS	021632-001	Feb 17, 2006
Vicuron	ERAXIS	anidulafungin	POWDER;INTRAVENOUS	021632-002	Nov 14, 2006
Vicuron	ERAXIS	anidulafungin	POWDER;INTRAVENOUS	021632-001	Feb 17, 2006

International Patents for ERAXIS

Country	Patent Number	Estimated Expiration
Portugal	561639
Germany	122008000006
Israel	165720
Israel	145185

Supplementary Protection Certificates for ERAXIS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0561639	SPC/GB08/016	United Kingdom		PRODUCT NAME: ANIDULAFUNGIN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: UK EU/1/07/416/001 20070920
0561639	CA 2008 00017	Denmark
0561639	C300334	Netherlands		PRODUCT NAME: ANIDULAFUNGIN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/07/416/001 20070920
0561639	C00561639/01	Switzerland		PRODUCT NAME: ANIDULAFUNGIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 58325 03.09.2009