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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Medtronic
McKesson
Cipla
Fuji
Baxter
Cerilliant
Harvard Business School
Covington

Generated: July 17, 2018

DrugPatentWatch Database Preview

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.
Summary for CRESEMBA
International Patents:24
US Patents:2
Applicants:1
NDAs:2
Suppliers / Packagers: 1
Bulk Api Vendors: 10
DailyMed Link:CRESEMBA at DailyMed
Drug patent expirations by year 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;IV (INFUSION)

*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.

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
BAL-8557-002
BAL8557-002
CHEBI:85977
CHEMBL3137333
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
Isavuconazonium sulfate (USAN)
Isavuconazonium sulfate [USAN]
MolPort-044-559-915
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 ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Astellas CRESEMBA isavuconazonium sulfate POWDER;IV (INFUSION) 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
Astellas CRESEMBA isavuconazonium sulfate POWDER;IV (INFUSION) 207501-001 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

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Non-Orange Book US Patents for CRESEMBA

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,151,182 Intermediates for N-substituted carbamoyloxyalkyl-azolium derivatives ➤ Sign Up
7,189,858 N-phenyl substituted carbamoyloxyalkyl-azolium derivatives ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for CRESEMBA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
939 Luxembourg ➤ Sign Up 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
2014000122 Germany ➤ Sign Up PRODUCT NAME: SITAGLIPTIN IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/07/383/001-018 20070321
90011-0 Sweden ➤ Sign Up PRODUCT NAME: ISAVUCONAZOLE; REG. NO/DATE: EU/1/15/1036 20151016
2016000011 Germany ➤ Sign Up 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
US Army
Queensland Health
Cipla
Chubb
Deloitte
Boehringer Ingelheim
Cerilliant
Johnson and Johnson

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 verifification 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.