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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 is one drug master file entry 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:	29
Clinical Trials:	11
Patent Applications:	1,137
DailyMed Link:	ERAXIS at DailyMed

Pharmacology for ERAXIS

Ingredient-type	Lipopeptides
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	INJECTABLE;IV (INFUSION)	021632-001	Feb 17, 2006		RX	Yes	Yes			Y	Y
Vicuron	ERAXIS	anidulafungin	INJECTABLE;IV (INFUSION)	021632-002	Nov 14, 2006		RX	Yes	Yes			Y	Y
Vicuron	ERAXIS	anidulafungin	INJECTABLE;IV (INFUSION)	021632-001	Feb 17, 2006		RX	Yes	Yes			Y
Vicuron	ERAXIS	anidulafungin	INJECTABLE;IV (INFUSION)	021632-001	Feb 17, 2006		RX	Yes	Yes			Y

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Expired US Patents for ERAXIS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Vicuron	ERAXIS	anidulafungin	INJECTABLE;IV (INFUSION)	021632-002	Nov 14, 2006
Vicuron	ERAXIS	anidulafungin	INJECTABLE;IV (INFUSION)	021632-001	Feb 17, 2006
Vicuron	ERAXIS	anidulafungin	INJECTABLE;IV (INFUSION)	021632-001	Feb 17, 2006
Vicuron	ERAXIS	anidulafungin	INJECTABLE;IV (INFUSION)	021632-002	Nov 14, 2006

Non-Orange Book US Patents for ERAXIS

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
6,743,777	Cyclic peptide antifungal agents and process for preparation thereof
5,932,543	Cyclic peptide antifungal agents and process for preparation thereof
7,790,744	Cyclic peptide antifungal agents and process for preparation thereof
6,916,784	Cyclic peptide antifungal agents and process for preparation thereof

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International Patents for ERAXIS

Country	Document Number	Estimated Expiration
Russian Federation	2129562
Israel	122315
Russian Federation	2250763
European Patent Office	0561639

Supplementary Protection Certificates for ERAXIS

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
00334	Netherlands		PRODUCT NAME: ANIDULAFUNGIN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/07/416/001 20070920
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
0561639/01	Switzerland		PRODUCT NAME: ANIDULAFUNGIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 58325 03.09.2009
2008 00017	Denmark