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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.

Summary for ERAXIS

International Patents:	67
US Patents:	3
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	33
Clinical Trials:	11
Patent Applications:	1,177
Drug Prices:	Drug price information for ERAXIS
DailyMed Link:	ERAXIS at DailyMed

Generic Entry Opportunity Date for ERAXIS

NDA:

021632

Dosage:

INJECTABLE;IV (INFUSION)

^*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.

Pharmacology for ERAXIS

Drug Class

Echinocandin Antifungal

Synonyms for ERAXIS

(4R,5R)-4,5-Dihydroxy-N(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 (6->1)-

(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 (6-

166663-25-8

663A258

9HLM53094I

AC1L4YAI

AKOS030526640

AN-5571

Anidulafungin

Anidulafungin (LY303366)

Anidulafungin [USAN:INN:BAN]

Anidulafungin [USAN:INN]

Anidulafungina

Anidulafungine

Anidulafunginum

AT-36943

BDBM50417554

C58H73N7O17

CHEBI:55346

CHEMBL264241

D0F9BY

DB00362

Ecalta

Ecalta (TN)

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)

Eraxis (TN)

J-010304

LS-63738

LY-303366

LY303366

MFCD00917070

MolPort-006-167-527

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,2R)-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[22.3.0.09

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',1

s4286

SCHEMBL38292

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

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	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

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	Document Number	Estimated Expiration
Yugoslavia	49108
Brazil	9301232
Hungary	211562
New Zealand	512085

Supplementary Protection Certificates for ERAXIS

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C/GB08/016	United Kingdom		PRODUCT NAME: ANIDULAFUNGIN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: UK EU/1/07/416/001 20070920
2008 00017	Denmark
0334	Netherlands		300334, 20130318, EXPIRES: 20180317
406	Luxembourg		91406, EXPIRES: 20180318