ANIDULAFUNGIN - Generic Drug Details

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What are the generic sources for anidulafungin and what is the scope of patent protection?

Anidulafungin is the generic ingredient in one branded drug marketed by Vicuron Holdings and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for anidulafungin. One supplier is listed for this compound.

Summary for ANIDULAFUNGIN

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	56
Clinical Trials:	37
Patent Applications:	4,963
What excipients (inactive ingredients) are in ANIDULAFUNGIN?	ANIDULAFUNGIN excipients list
DailyMed Link:	ANIDULAFUNGIN at DailyMed

Recent Clinical Trials for ANIDULAFUNGIN

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

Sponsor	Phase
Scynexis, Inc.	Phase 3
ZonMw: The Netherlands Organisation for Health Research and Development	Phase 3
Stichting Hemato-Oncologie voor Volwassenen Nederland	Phase 3

See all ANIDULAFUNGIN clinical trials

Pharmacology for ANIDULAFUNGIN

Drug Class	Echinocandin Antifungal

Anatomical Therapeutic Chemical (ATC) Classes for ANIDULAFUNGIN

J02AX	Other antimycotics for systemic use
J02A	ANTIMYCOTICS FOR SYSTEMIC USE
J02	ANTIMYCOTICS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for ANIDULAFUNGIN

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Glossary

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

Expired US Patents for ANIDULAFUNGIN

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

EU/EMA Drug Approvals for ANIDULAFUNGIN

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Pfizer Europe MA EEIG	Ecalta	anidulafungin	EMEA/H/C/000788 Treatment of invasive candidiasis in adults and paediatric patients aged 1 month to < 18 years.	Authorised	no	no	no	2007-09-20
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

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