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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 April 12, 2021. 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:	35
Clinical Trials:	11
Patent Applications:	1,461
Drug Prices:	Drug price information for ERAXIS
DailyMed Link:	ERAXIS at DailyMed

See drug prices for ERAXIS

Generic Entry Opportunity Date for ERAXIS

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

See all ERAXIS clinical trials

Pharmacology for ERAXIS

Drug Class

Echinocandin Antifungal

Synonyms for ERAXIS

(4R,5R)-4,5-Dihydroxy-N(sup 2)-((4'-(pentyloxy)-p-terphenyl-4-yl)carbonyl)-L-ornithyl-L-threonyl-trans-4-hydroxy-L-prolyl-(S)-4-hydroxy-4-(p-hydroxyphenyl)-L-threonyl-L-threonyl-(3S,4S)-3-hydroxy-4-methyl-L-proline cyclic (

166663-25-8

663A258

9HLM53094I

A13436

Anidulafungin

Anidulafungin (LY303366)

Anidulafungin [USAN:INN:BAN]

Anidulafungin [USAN:INN]

anidulafungin-ly303366

Anidulafungina

Anidulafungine

Anidulafunginum

AT-36943

BDBM50417554

C58H73N7O17

CHEBI:55346

CHEMBL264241

D70013

DB00362

Ecalta

Echinocandin B, 1-((4R,5R)-4,5-dihydroxy-N(sup 2)-((4'-(pentyloxy)(1,1':4',1'-terphenyl)-4-yl)carbonyl)-L-ornithine)-

Echinocandin B, 1-((4R,5R)-4,5-dihydroxy-N2-((4''-(pentyloxy)(1,1':4',1''-terphenyl)-4-yl)carbonyl)-L-ornithine)

Echinocandin B, 1-((4R,5R)-4,5-dihydroxy-N2-((4"-(pentyloxy)(1,1':4',1"-terphenyl)-4-yl)carbonyl)-L-ornithine)

J-010304

LS-63738

LY-303366

LY303366

N-((2R,6S,9S,11R,12R,14aS,15S,16S,20S,23S,25aS)-23-((1S,2S)-1,2-dihydroxy-2-(4-hydroxyphenyl)ethyl)-2,11,12,15-tetrahydroxy-6,20-bis((R)-1-hydroxyethyl)-16-methyl-5,8,14,19,22,25-hexaoxo

N-[(3S,6S,9S,11R,15S,18S,20R,21R,24S,25S,26S)-6-[(1S,2S)-1,2-dihydroxy-2-(4-hydroxyphenyl)ethyl]-11,20,21,25-tetrahydroxy-3,15-bis[(1R)-1-hydroxyethyl]-26-methyl-2,5,8,14,17,23-hexaoxo-1,4,7,13,16,22-hexaazatricyclo[22.3.0.0

N-[[(1S,2S)-1,2-dihydroxy-2-(4-hydroxyphenyl)ethyl]-tetrahydroxy-bis[(1R)-1-hydroxyethyl]-methyl-hexaoxo-[?]yl]-4-[4-(4-pentoxyphenyl)phenyl]benzamide

N-{(2R,6S,9S,11R,12R,14aS,15S,16S,20S,23S,25aS)-23-[(1S,2S)-1,2-dihydroxy-2-(4-hydroxyphenyl)ethyl]-2,11,12,15-tetrahydroxy-6,20-bis[(1R)-1-hydroxyethyl]-16-methyl-5,8,14,19,22,25-hexaoxotetracosahydro-1H-dipyrrolo[2,1-c:2'

NCGC00386349-01

Q4764531

s4286

SCHEMBL38292

SW222238-1

tetracosahydro-1H-dipyrrolo[2,1-c:2',1'-l][1,4,7,10,13,16]hexaazacyclohenicosin-9-yl)-4''-(pentyloxy)-[1,1':4',1''-terphenyl]-4-carboxamide

UNII-9HLM53094I

V-Echinocandin

VER-002

VER002

Z-3192

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			Y
Vicuron	ERAXIS	anidulafungin	POWDER;INTRAVENOUS	021632-001	Feb 17, 2006		RX	Yes	Yes			Y
Vicuron	ERAXIS	anidulafungin	POWDER;INTRAVENOUS	021632-002	Nov 14, 2006		RX	Yes	Yes			Y

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	021632-001	Feb 17, 2006
Vicuron	ERAXIS	anidulafungin	POWDER;INTRAVENOUS	021632-002	Nov 14, 2006
Vicuron	ERAXIS	anidulafungin	POWDER;INTRAVENOUS	021632-002	Nov 14, 2006

International Patents for ERAXIS

Country	Patent Number	Estimated Expiration
South Korea	100800503
Australia	2003248692
Czech Republic	9300416
Taiwan	264477
South Korea	100256036

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	C300334	Netherlands		PRODUCT NAME: ANIDULAFUNGIN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/07/416/001 20070920
0561639	CA 2008 00017	Denmark
0561639	C00561639/01	Switzerland		PRODUCT NAME: ANIDULAFUNGIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 58325 03.09.2009
0561639	SPC002/2008	Ireland		SPC002/2008: 20081105, EXPIRES: 20180317