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Serving leading biopharmaceutical companies globally:

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Generated: December 13, 2017

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:1
Applicant:1
Ingredient:1
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 0469-3211-10 10 VIAL, SINGLE-DOSE in 1 CARTON (0469-3211-10) > 10 mL in 1 VIAL, SINGLE-DOSE
MYCAMINE micafungin sodium INJECTABLE;IV (INFUSION) 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

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)StrengthEQ 50MG BASE/VIAL
Approval Date:Mar 16, 2005TE:RLD:Yes
Patent:► SubscribePatent Expiration:Mar 16, 2019Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF ESOPHAGEAL CANDIDIASIS AND PROPHYLAXIS OF CANDIDA INFECTIONS IN HSCT PATIENTS
Patent:► SubscribePatent Expiration:Mar 16, 2019Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF PATIENTS WITH CANDIDEMIA, ACUTE DISSEMINATED CANDIDIASIS, CANDIDA PERITONITIS AND ABCESSES
Patent:► SubscribePatent Expiration:Jan 8, 2021Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF ESOPHAGEAL CANDIDIASIS AND PROPHYLAXIS OF CANDIDA INFECTIONS IN HSCT PATIENTS

Expired Orange Book Patents for NDA: 021506

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
AstellasMYCAMINEmicafungin sodiumINJECTABLE;IV (INFUSION)021506-002Mar 16, 2005► Subscribe► Subscribe
AstellasMYCAMINEmicafungin sodiumINJECTABLE;IV (INFUSION)021506-003Jun 27, 2006► Subscribe► Subscribe
AstellasMYCAMINEmicafungin sodiumINJECTABLE;IV (INFUSION)021506-003Jun 27, 2006► Subscribe► Subscribe
AstellasMYCAMINEmicafungin sodiumINJECTABLE;IV (INFUSION)021506-002Mar 16, 2005► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Merck
US Department of Justice
Baxter
Federal Trade Commission
Teva
Chubb
Moodys
Fuji
Johnson and Johnson
US Army

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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