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Isavuconazonium sulfate - Generic Drug Details

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What are the generic sources for isavuconazonium sulfate and what is the scope of patent protection?

Isavuconazonium sulfate is the generic ingredient in one branded drug marketed by Astellas and is included in two NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Isavuconazonium sulfate has twenty-four patent family members in nineteen countries.

One supplier is listed for this compound.

Summary for isavuconazonium sulfate

International Patents:	24
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	2
Suppliers / Packagers:	1
Bulk Api Vendors:	14
Clinical Trials:	7
DailyMed Link:	isavuconazonium sulfate at DailyMed

Recent Clinical Trials for isavuconazonium sulfate

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Astellas Pharma Global Development, Inc.	Phase 2
Asahi Kasei Pharma Corporation	Phase 3
Astellas Pharma US, Inc.	Phase 2

See all isavuconazonium sulfate clinical trials

Pharmacology for isavuconazonium sulfate

Drug Class	Azole Antifungal
Mechanism of Action	Cytochrome P450 3A4 Inhibitors Organic Cation Transporter 2 Inhibitors P-Glycoprotein Inhibitors

US Patents and Regulatory Information for isavuconazonium sulfate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astellas	CRESEMBA	isavuconazonium sulfate	POWDER;INTRAVENOUS	207501-001	Mar 6, 2015		RX	Yes	Yes				Y
Astellas	CRESEMBA	isavuconazonium sulfate	CAPSULE;ORAL	207500-001	Mar 6, 2015		RX	Yes	Yes				Y
Astellas	CRESEMBA	isavuconazonium sulfate	POWDER;INTRAVENOUS	207501-001	Mar 6, 2015		RX	Yes	Yes

International Patents for isavuconazonium sulfate

Country	Patent Number	Estimated Expiration
Canada	2388320
Spain	2238341
South Korea	100449797

Supplementary Protection Certificates for isavuconazonium sulfate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1280795	2015/073	Ireland		PRODUCT NAME: ISAVUCONAZOLE AS ISAVUCONAZONIUM SULFATE OR AS ISAVUCONAZONIUM SALT WITH ANY OTHER PHARMACEUTICALLY ACCEPTABLE ANION, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE, OR SOLVATE; REGISTRATION NO/DATE: EU/1/15/1036 20151015
1280795	512	Finland
1280795	CA 2016 00002	Denmark		PRODUCT NAME: ISAVUCONAZOLE AS ISAVUCONAZONIUM SULFATE OR AS AN ISAVUCONAZONIUM SALT WITH ANY OTHER PHARMACEUTICALLY ACCEPTABLE ANION, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE, OR SOLVATE; REG. NO/DATE: EU/1/15/1036 20151019