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Last Updated: June 18, 2021

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CRESEMBA Drug Profile


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Which patents cover Cresemba, and when can generic versions of Cresemba launch?

Cresemba is a drug marketed by Astellas and is included in two NDAs. There is one patent 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.

DrugPatentWatch® 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:1
Applicants:1
NDAs:2
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 16
Clinical Trials: 4
Drug Prices: Drug price information for CRESEMBA
What excipients (inactive ingredients) are in CRESEMBA?CRESEMBA excipients list
DailyMed Link:CRESEMBA at DailyMed
Drug patent expirations by year for CRESEMBA
Drug Prices for CRESEMBA

See drug prices for CRESEMBA

DrugPatentWatch® Estimated 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 3
Jeffrey Jenks, MD, MPHPhase 3
UNC Lineberger Comprehensive Cancer CenterPhase 2

See all CRESEMBA clinical trials

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   Try Before You Buy   Try Before You Buy Y   Try Before You Buy
Astellas CRESEMBA isavuconazonium sulfate POWDER;INTRAVENOUS 207501-001 Mar 6, 2015 RX Yes Yes   Try Before You Buy   Try Before You Buy   Try Before You Buy
Astellas CRESEMBA isavuconazonium sulfate POWDER;INTRAVENOUS 207501-001 Mar 6, 2015 RX Yes Yes   Try Before You Buy   Try Before You Buy Y   Try Before You Buy
Astellas CRESEMBA isavuconazonium sulfate CAPSULE;ORAL 207500-001 Mar 6, 2015 RX Yes Yes   Try Before You Buy   Try Before You Buy   Try Before You Buy
>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 CRESEMBA

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

Supplementary Protection Certificates for CRESEMBA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1280795 122014000122 Germany   Try Before You Buy PRODUCT NAME: SITAGLIPTIN IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/07/383/001-018 20070321
1280795 15C0096 France   Try Before You Buy PRODUCT NAME: ISAVUCONAZOLE; REGISTRATION NO/DATE: EU/1/15/1036 20151015
1280795 CA 2016 00002 Denmark   Try Before You Buy 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
1280795 122016000011 Germany   Try Before You Buy 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
McKesson
Harvard Business School
Express Scripts
Merck
AstraZeneca

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