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Last Updated: December 2, 2024

Details for New Drug Application (NDA): 207501


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NDA 207501 describes CRESEMBA, which is a drug marketed by Astellas and is included in two NDAs. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the CRESEMBA profile page.

The generic ingredient in CRESEMBA is isavuconazonium sulfate. One supplier is listed for this compound. Additional details are available on the isavuconazonium sulfate profile page.
Summary for 207501
Tradename:CRESEMBA
Applicant:Astellas
Ingredient:isavuconazonium sulfate
Patents:1
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 207501
Generic Entry Date for 207501*:
Constraining patent/regulatory exclusivity:
TREATMENT OF INVASIVE MUCORMYCOSIS IN PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER
Dosage:
POWDER;INTRAVENOUS

*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.

Suppliers and Packaging for NDA: 207501
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CRESEMBA isavuconazonium sulfate POWDER;INTRAVENOUS 207501 NDA Astellas Pharma US, Inc. 0469-0420 0469-0420-99 10 CARTON in 1 CARTON (0469-0420-99) / 1 VIAL, SINGLE-DOSE in 1 CARTON (0469-0420-01) / 5 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAVENOUSStrength372MG
Approval Date:Mar 6, 2015TE:RLD:Yes
Regulatory Exclusivity Expiration:Sep 6, 2025
Regulatory Exclusivity Use:GENERATING ANTIBIOTIC INCENTIVES NOW
Regulatory Exclusivity Expiration:Sep 6, 2027
Regulatory Exclusivity Use:GENERATING ANTIBIOTIC INCENTIVES NOW
Regulatory Exclusivity Expiration:Mar 6, 2020
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY

Expired US Patents for NDA 207501

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astellas CRESEMBA isavuconazonium sulfate POWDER;INTRAVENOUS 207501-001 Mar 6, 2015 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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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 verification 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.