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Last Updated: January 27, 2020

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CRESEMBA Drug Profile

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Which patents cover Cresemba, and what generic alternatives are available?

Cresemba is a drug marketed by Astellas and is included in two NDAs. There are two patents protecting this drug.

This drug has twenty-four patent family members in nineteen countries.

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.

US ANDA Litigation and Generic Entry Outlook for Cresemba

Cresemba was eligible for patent challenges on March 6, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 6, 2027. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for CRESEMBA
International Patents:24
US Patents:2
Applicants:1
NDAs:2
Suppliers / Packagers: 1
Bulk Api Vendors: 13
Clinical Trials: 2
Drug Prices: Drug price information for CRESEMBA
DailyMed Link:CRESEMBA at DailyMed
Drug patent expirations by year for CRESEMBA
Drug Prices for CRESEMBA

See drug prices for CRESEMBA

Generic Entry Opportunity Date for CRESEMBA
Generic Entry Dates for CRESEMBA*:
Constraining patent/regulatory exclusivity:
GENERATING ANTIBIOTIC INCENTIVES NOW
NDA:
Dosage:
CAPSULE;ORAL
Generic Entry Dates for CRESEMBA*:
Constraining patent/regulatory exclusivity:
GENERATING ANTIBIOTIC INCENTIVES NOW
NDA:
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 CRESEMBA

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

SponsorPhase
Astellas Pharma Global Development, Inc.Phase 1
Astellas Pharma Global Development, Inc.Phase 2

See all CRESEMBA clinical trials

Synonyms for CRESEMBA
(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
AS-35043
BAL-8557-002
BAL8557-002
CHEBI:85977
CHEMBL3137333
D10643
EX-A1786
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)
Isavuconazonium sulfate
Isavuconazonium sulfate (USAN)
Isavuconazonium sulfate [USAN]
MolPort-044-559-915
SB16704
SC-12899
UNII-31Q44514JV

US Patents and Regulatory Information for CRESEMBA

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

Supplementary Protection Certificates for CRESEMBA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1280795 SPC/GB15/078 United Kingdom   Start Trial 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 122016000011 Germany   Start Trial 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
1280795 92939 Luxembourg   Start Trial 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   Start Trial 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   Start Trial 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 512 Finland   Start Trial
1280795 122014000122 Germany   Start Trial PRODUCT NAME: SITAGLIPTIN IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/07/383/001-018 20070321
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Harvard Business School
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