Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

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Last Updated: October 22, 2019

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: 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

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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.

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
>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 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 1690011-0 Sweden   Start Trial PRODUCT NAME: ISAVUCONAZOLE; REG. NO/DATE: EU/1/15/1036 20151016
1280795 CR 2016 00002 Denmark   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; REG. NO/DATE: EU/1/15/1036 20151019
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Express Scripts
McKinsey
Mallinckrodt
McKesson
Moodys

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.