Details for New Drug Application (NDA): 207500

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NDA 207500 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 207500

Tradename:	CRESEMBA
Applicant:	Astellas
Ingredient:	isavuconazonium sulfate
Patents:	3

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 207500

Generic Entry Date for 207500^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: TREATMENT OF INVASIVE ASPERGILLOSIS IN PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER WHO WEIGH 16 KILOGRAMS (KG) AND GREATER Dosage: CAPSULE;ORAL

^*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: 207500

Mechanism of Action	Cytochrome P450 3A4 Inhibitors Organic Cation Transporter 2 Inhibitors P-Glycoprotein Inhibitors

Suppliers and Packaging for NDA: 207500

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CRESEMBA	isavuconazonium sulfate	CAPSULE;ORAL	207500	NDA	Astellas Pharma US, Inc.	0469-0520	0469-0520-14	4 CARTON in 1 CARTON (0469-0520-14) / 14 BLISTER PACK in 1 CARTON (0469-0520-02) / 1 CAPSULE in 1 BLISTER PACK
CRESEMBA	isavuconazonium sulfate	CAPSULE;ORAL	207500	NDA	Astellas Pharma US, Inc.	0469-2860	0469-2860-35	35 BLISTER PACK in 1 CARTON (0469-2860-35) / 1 CAPSULE in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	186MG
Approval Date:	Mar 6, 2015	TE:		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 207500

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astellas	CRESEMBA	isavuconazonium sulfate	CAPSULE;ORAL	207500-001	Mar 6, 2015	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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