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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
AstraZeneca
Deloitte
Colorcon
Mallinckrodt
Harvard Business School
McKinsey
Queensland Health
Chinese Patent Office

Generated: April 22, 2018

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 six 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
Therapeutic Class:Antifungals
Pharmacology for NDA: 021506
Ingredient-typeLipopeptides
Suppliers and Packaging for NDA: 021506
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MYCAMINE micafungin sodium INJECTABLE;IV (INFUSION) 021506 NDA Astellas Pharma US, Inc. 0469-3211 N 0469-3211-10
MYCAMINE micafungin sodium INJECTABLE;IV (INFUSION) 021506 NDA Astellas Pharma US, Inc. 0469-3211 N 0469-3211-99

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)StrengthEQ 50MG BASE/VIAL
Approval Date:Mar 16, 2005TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Mar 16, 2019Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF ESOPHAGEAL CANDIDIASIS AND PROPHYLAXIS OF CANDIDA INFECTIONS IN HSCT PATIENTS
Patent:➤ Sign UpPatent Expiration:Mar 16, 2019Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF PATIENTS WITH CANDIDEMIA, ACUTE DISSEMINATED CANDIDIASIS, CANDIDA PERITONITIS AND ABSCESSES
Patent:➤ Sign UpPatent 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;IV (INFUSION) 021506-002 Mar 16, 2005 ➤ Sign Up ➤ Sign Up
Astellas MYCAMINE micafungin sodium INJECTABLE;IV (INFUSION) 021506-003 Jun 27, 2006 ➤ Sign Up ➤ Sign Up
Astellas MYCAMINE micafungin sodium INJECTABLE;IV (INFUSION) 021506-003 Jun 27, 2006 ➤ Sign Up ➤ Sign Up
Astellas MYCAMINE micafungin sodium INJECTABLE;IV (INFUSION) 021506-002 Mar 16, 2005 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Johnson and Johnson
Boehringer Ingelheim
Daiichi Sankyo
Covington
Federal Trade Commission
Colorcon
Julphar
Chinese Patent Office

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