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Generated: October 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021632

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NDA 021632 describes ERAXIS, which is a drug marketed by Vicuron and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the ERAXIS profile page.

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 021632
Tradename:ERAXIS
Applicant:Vicuron
Ingredient:anidulafungin
Patents:3
Generic Entry Opportunity Date for 021632
Generic Entry Date for 021632*:
Constraining patent/regulatory exclusivity:
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 NDA: 021632
Ingredient-typeLipopeptides
Suppliers and Packaging for NDA: 021632
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ERAXIS anidulafungin POWDER;INTRAVENOUS 021632 NDA Roerig 0049-0114 0049-0114-28 15 mL in 1 VIAL, SINGLE-USE (0049-0114-28)
ERAXIS anidulafungin POWDER;INTRAVENOUS 021632 NDA Roerig 0049-0116 0049-0116-28 30 mL in 1 VIAL, SINGLE-USE (0049-0116-28)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAVENOUSStrength50MG/VIAL
Approval Date:Feb 17, 2006TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Feb 17, 2020Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF FUNGAL INFECTIONS
Patent:➤ Try a Free TrialPatent Expiration:Apr 12, 2021Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF FUNGAL INFECTIONS
Patent:➤ Try a Free TrialPatent Expiration:Apr 12, 2021Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF FUNGAL INFECTIONS

Expired US Patents for NDA 021632

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

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