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 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:	52
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

Generic Entry Dates for isavuconazonium sulfate^: ⤷ 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
Generic Entry Dates for isavuconazonium sulfate^: ⤷ Sign Up* 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

Paragraph IV (Patent) Challenges for ISAVUCONAZONIUM SULFATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CRESEMBA	Capsules	isavuconazonium sulfate	186 mg	207500	4	2024-09-06
CRESEMBA	For Injection	isavuconazonium sulfate	372 mg/vial	207501	2	2024-09-06

US Patents and Regulatory Information for isavuconazonium sulfate

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Glossary

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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	207500-002	Nov 22, 2022		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Astellas	CRESEMBA	isavuconazonium sulfate	CAPSULE;ORAL	207500-001	Mar 6, 2015		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Astellas	CRESEMBA	isavuconazonium sulfate	CAPSULE;ORAL	207500-001	Mar 6, 2015		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Astellas	CRESEMBA	isavuconazonium sulfate	POWDER;INTRAVENOUS	207501-001	Mar 6, 2015		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Astellas	CRESEMBA	isavuconazonium sulfate	POWDER;INTRAVENOUS	207501-001	Mar 6, 2015		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Astellas	CRESEMBA	isavuconazonium sulfate	CAPSULE;ORAL	207500-001	Mar 6, 2015		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for isavuconazonium sulfate

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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
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

International Patents for isavuconazonium sulfate

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Country	Patent Number	Title	Estimated Expiration
Brazil	PI0015254	compostos derivados de carbamoiloxialquil-azólio, seu uso, bem como composição farmacêutica compreendendo os mesmos.	⤷ Sign Up
Luxembourg	92939		⤷ Sign Up
World Intellectual Property Organization (WIPO)	2008037359		⤷ Sign Up
Canada	2388320	DERIVES CARBAMOYLOXYALKYL-AZOLIUM N-SUBSTITUES (N-SUBSTITUTED CARBAMOYLOXYALKYL-AZOLIUM DERIVATIVES)	⤷ Sign Up
European Patent Office	1280795	DERIVES CARBAMOYLOXYALKYL-AZOLIUM N-SUBSTITUES (N-SUBSTITUTED CARBAMOYLOXYALKYL-AZOLIUM DERIVATIVES)	⤷ Sign Up
Canada	2663941	FORMES GALENIQUES SOLIDES STABILISEES, ET LEUR PROCEDE DE PRODUCTION (STABILIZED SOLID FORMS AND METHOD FOR THE PRODUCTION THEREOF)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for isavuconazonium sulfate

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1280795	SPC/GB15/078	United Kingdom	⤷ Sign Up	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
1280795	15C0096	France	⤷ Sign Up	PRODUCT NAME: ISAVUCONAZOLE; REGISTRATION NO/DATE: EU/1/15/1036 20151015
1280795	300791	Netherlands	⤷ Sign Up	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	2015/073	Ireland	⤷ Sign Up	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	122014000122	Germany	⤷ Sign Up	PRODUCT NAME: SITAGLIPTIN IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/07/383/001-018 20070321
1280795	1690011-0	Sweden	⤷ Sign Up	PRODUCT NAME: ISAVUCONAZOLE; REG. NO/DATE: EU/1/15/1036 20151016
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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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.