Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 18, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021506

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NDA 021506 describes MYCAMINE, which is a drug marketed by Astellas and is included in one NDA. It is available from one supplier. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the MYCAMINE profile page.

The generic ingredient in MYCAMINE is micafungin sodium. There are eight drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the micafungin sodium profile page.
Summary for 021506
Tradename:MYCAMINE
Applicant:Astellas
Ingredient:micafungin sodium
Patents:2
Pharmacology for NDA: 021506
Suppliers and Packaging for NDA: 021506
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MYCAMINE micafungin sodium INJECTABLE;INTRAVENOUS 021506 NDA Astellas Pharma US, Inc. 0469-3211 0469-3211-10 10 VIAL, SINGLE-DOSE in 1 CARTON (0469-3211-10) > 10 mL in 1 VIAL, SINGLE-DOSE
MYCAMINE micafungin sodium INJECTABLE;INTRAVENOUS 021506 NDA Astellas Pharma US, Inc. 0469-3211 0469-3211-99 10 VIAL, SINGLE-DOSE in 1 CARTON (0469-3211-99) > 10 mL in 1 VIAL, SINGLE-DOSE
Paragraph IV (Patent) Challenges for 021506
Tradename Dosage Ingredient NDA Submissiondate
MYCAMINE INJECTABLE;INTRAVENOUS micafungin sodium 021506 2014-06-16

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrengthEQ 50MG BASE/VIAL
Approval Date:Mar 16, 2005TE:APRLD:Yes
Patent:  Start TrialPatent Expiration:Mar 16, 2019Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF ESOPHAGEAL CANDIDIASIS AND PROPHYLAXIS OF CANDIDA INFECTIONS IN HSCT PATIENTS
Patent:  Start TrialPatent Expiration:Mar 16, 2019Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF PATIENTS WITH CANDIDEMIA, ACUTE DISSEMINATED CANDIDIASIS, CANDIDA PERITONITIS AND ABSCESSES
Patent:  Start TrialPatent Expiration:Jan 8, 2021Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF ESOPHAGEAL CANDIDIASIS AND PROPHYLAXIS OF CANDIDA INFECTIONS IN HSCT PATIENTS

Expired US Patents for NDA 021506

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astellas MYCAMINE micafungin sodium INJECTABLE;INTRAVENOUS 021506-003 Jun 27, 2006   Start Trial   Start Trial
Astellas MYCAMINE micafungin sodium INJECTABLE;INTRAVENOUS 021506-002 Mar 16, 2005   Start Trial   Start Trial
Astellas MYCAMINE micafungin sodium INJECTABLE;INTRAVENOUS 021506-002 Mar 16, 2005   Start Trial   Start Trial
Astellas MYCAMINE micafungin sodium INJECTABLE;INTRAVENOUS 021506-003 Jun 27, 2006   Start Trial   Start Trial
Astellas MYCAMINE micafungin sodium INJECTABLE;INTRAVENOUS 021506-002 Mar 16, 2005   Start Trial   Start Trial
Astellas MYCAMINE micafungin sodium INJECTABLE;INTRAVENOUS 021506-003 Jun 27, 2006   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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