Isavuconazonium sulfate - Generic Drug Details

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 three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Isavuconazonium sulfate has thirty-two patent family members in nineteen countries.

One supplier is listed for this compound.

Summary for isavuconazonium sulfate

International Patents:	32
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	34
Clinical Trials:	8
Patent Applications:	97
What excipients (inactive ingredients) are in isavuconazonium sulfate?	isavuconazonium sulfate excipients list
DailyMed Link:	isavuconazonium sulfate at DailyMed

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

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

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.

Recent Clinical Trials for isavuconazonium sulfate

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

Sponsor	Phase
Jeffrey Jenks, MD, MPH	Phase 3
Astellas Pharma Global Development, Inc.	Phase 3
Astellas Pharma Global Development, 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	CAPSULE;ORAL	207500-001	Mar 6, 2015		RX	Yes	Yes
Astellas	CRESEMBA	isavuconazonium sulfate	CAPSULE;ORAL	207500-001	Mar 6, 2015		RX	Yes	Yes
Astellas	CRESEMBA	isavuconazonium sulfate	CAPSULE;ORAL	207500-002	Nov 22, 2022		RX	Yes	No
Astellas	CRESEMBA	isavuconazonium sulfate	POWDER;INTRAVENOUS	207501-001	Mar 6, 2015		RX	Yes	Yes
Astellas	CRESEMBA	isavuconazonium sulfate	CAPSULE;ORAL	207500-002	Nov 22, 2022		RX	Yes	No

Expired US Patents for isavuconazonium sulfate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astellas	CRESEMBA	isavuconazonium sulfate	CAPSULE;ORAL	207500-001	Mar 6, 2015
Astellas	CRESEMBA	isavuconazonium sulfate	POWDER;INTRAVENOUS	207501-001	Mar 6, 2015

International Patents for isavuconazonium sulfate

Country	Patent Number	Title	Estimated Expiration
South Korea	100449797
Australia	2835201
World Intellectual Property Organization (WIPO)	2008037359
Germany	60018989
Japan	3787307

Supplementary Protection Certificates for isavuconazonium sulfate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1280795	122014000122	Germany		PRODUCT NAME: SITAGLIPTIN IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/07/383/001-018 20070321
1280795	92939	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
1280795	300791	Netherlands		PRODUCT NAME: ISAVUCONAZOL ALS ISAVUCONAZONIUM SULFAAT OF ALS EEN ISAVUCONAZONIUM ZOUT MET ELK ANDER FARMACEUTISCH AANVAARDBAAR ANION, NAAR KEUZE IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, HYDRAAT OF SOLVAAT; REGISTRATION NO/DATE: EU/1/15/1036 20151019
1280795	5/2016	Austria		PRODUCT NAME: ISAVUCONAZOL ALS ISAVUCONAZONIUMSULFAT ODER ALS EIN ISAVUCONAZONIUMSALZ MIT EINEM ANDEREN PHARMAZEUTISCH ANNEHMBAREN ANION, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, HYDRATS ODER SOLVATS; REGISTRATION NO/DATE: EU/1/15/1036 (MITTEILUNG) 20151015
1280795	SPC/GB15/078	United Kingdom		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; REGISTERED: UK EU/1/15/1036 20151019