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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 isavuconazonium sulfate 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:	10
Clinical Trials:	5
DailyMed Link:	isavuconazonium sulfate at DailyMed

Pharmacology for isavuconazonium sulfate

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

Synonyms for isavuconazonium sulfate

(2-{[(1-{1-[(2R,3R)-3-[4-(4-cyanophenyl)-1,3-thiazol-2-yl]-2-(2,5-difluorophenyl)-2-hydroxybutyl]-1H-1,2,4-triazol-4-ium-4-yl}ethoxy)carbonyl](methyl)amino}pyridin-3-yl)methyl N-methylglycinate hydrogen sulfate

1-((2R,3R)-3-(4-(4-Cyanophenyl)-1,3-thiazol-2-yl)-2-(2,5-difluorophenyl)-2-hydroxybutyl)-4-((1RS)-1-((methyl(3-((((methylamino)acetyl)oxy)methyl)pyridin-2-yl)carbamoyl)oxy)ethyl)-1H-1,2,4-triazol-4-ium monosulfate

31Q44514JV

946075-13-4

AKOS030527357

BAL-8557-002

BAL8557-002

CHEBI:85977

CHEMBL3137333

Cresemba

D10643

Glycine, N-methyl-, (2-(((1-(1-((2R,3R)-3-(4-(4-cyanophenyl)-2-thiazolyl)-2-(2,5-difluorophenyl)-2-hydroxybutyl)-4H-1,2,4-triazolium-4-yl)ethoxy)carbonyl)methylamino)-3-pyridinyl)methyl ester, sulfate (1:1)

Isavuconazonium sulfate (USAN)

Isavuconazonium sulfate [USAN]

MolPort-044-559-915

SC-12899

UNII-31Q44514JV

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	CAPSULE;ORAL	207500-001	Mar 6, 2015		RX	Yes	Yes
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
Astellas	CRESEMBA	isavuconazonium sulfate	CAPSULE;ORAL	207500-001	Mar 6, 2015		RX	Yes	Yes
Astellas	CRESEMBA	isavuconazonium sulfate	POWDER;INTRAVENOUS	207501-001	Mar 6, 2015		RX	Yes	Yes

International Patents for isavuconazonium sulfate

Country	Document Number	Estimated Expiration
South Korea	100449797
Austria	291575
Portugal	1280795
Australia	2835201
Turkey	200201205

Supplementary Protection Certificates for isavuconazonium sulfate

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2016000011	Germany		PRODUCT NAME: ISAVUCONAZONIUM ALS ISAVUCONAZONIUM-SULFAT ODER ALS SALZ MIT EINEM ANDEREN PHARMAZEUTISCH VERTRAEGLICHEN ANION, SOWIE HYDRATE ODER SOLVATE DAVON; REGISTRATION NO/DATE: EU/1/15/1036 20151015
939	Luxembourg		PRODUCT NAME: ISAVUCONBAZOLE EN TANT QUE SULFATE D'ISAVUCONAZONIUM OU EN TANT QUE SEL D'ISAVUCONAZONIUM AVEC TOUT AUTRE ANION PHARMACEUTIQUEMENT ACCEPTABLE, OPTIONNELLEMENT SOUS FORME D'UN SEL, HYDRATE OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE; FIRST REGISTRATION: 20151019
2	Finland
C0096	France		PRODUCT NAME: ISAVUCONAZOLE; REGISTRATION NO/DATE: EU/1/15/1036 20151015
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