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Last Updated: October 4, 2024

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CRESEMBA Drug Patent Profile


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When do Cresemba patents expire, and what generic alternatives are available?

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

This drug has thirty-two 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 December 8, 2030. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for CRESEMBA
International Patents:32
US Patents:3
Applicants:1
NDAs:2
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 34
Clinical Trials: 5
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 Loss of Exclusivity (LOE) Date for CRESEMBA
Generic Entry Dates for CRESEMBA*:
Constraining patent/regulatory exclusivity:
TREATMENT OF INVASIVE ASPERGILLOSIS IN PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER WHO WEIGH 16 KILOGRAMS (KG) AND GREATER
NDA:
Dosage:
CAPSULE;ORAL
Generic Entry Dates for CRESEMBA*:
Constraining patent/regulatory exclusivity:
TREATMENT OF INVASIVE MUCORMYCOSIS IN PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER
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
PfizerPhase 4
Jeffrey Jenks, MD, MPHPhase 3
Astellas Pharma Global Development, Inc.Phase 3

See all CRESEMBA clinical trials

US Patents and Regulatory Information for CRESEMBA

CRESEMBA is protected by three US patents and fifteen FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of CRESEMBA is ⤷  Sign Up.

This potential generic entry date is based on TREATMENT OF INVASIVE ASPERGILLOSIS IN PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER WHO WEIGH 16 KILOGRAMS (KG) AND GREATER.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting CRESEMBA

Active ingredient containing stabilised solid forms and method for the production thereof
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Active ingredient containing stabilised solid medicinal forms and methods for the production thereof
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

N-substituted carbamoyloxyalkyl-azolium derivatives
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

FDA Regulatory Exclusivity protecting CRESEMBA

TREATMENT OF INVASIVE ASPERGILLOSIS IN PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER WHO WEIGH 16 KILOGRAMS (KG) AND GREATER
Exclusivity Expiration: ⤷  Sign Up

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷  Sign Up

NEW PATIENT POPULATION
Exclusivity Expiration: ⤷  Sign Up

FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S).AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
Exclusivity Expiration: ⤷  Sign Up

TREATMENT OF INVASIVE MUCORMYCOSIS IN PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER WHO WEIGH 16 KG AND GREATER
Exclusivity Expiration: ⤷  Sign Up

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷  Sign Up

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷  Sign Up

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷  Sign Up

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷  Sign Up

GENERATING ANTIBIOTIC INCENTIVES NOW
Exclusivity Expiration: ⤷  Sign Up

GENERATING ANTIBIOTIC INCENTIVES NOW
Exclusivity Expiration: ⤷  Sign Up

TREATMENT OF INVASIVE MUCORMYCOSIS IN PATIENTS 18 YEARS OF AGE AND OLDER
Exclusivity Expiration: ⤷  Sign Up

TREATMENT OF INVASIVE ASPERGILLOSIS
Exclusivity Expiration: ⤷  Sign Up

TREATMENT OF INVASIVE MUCORMYCOSIS IN PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER
Exclusivity Expiration: ⤷  Sign Up

TREATMENT OF INVASIVE ASPERGILLOSIS IN PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER
Exclusivity Expiration: ⤷  Sign Up

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 POWDER;INTRAVENOUS 207501-001 Mar 6, 2015 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  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;INTRAVENOUS 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

International Patents for CRESEMBA

When does loss-of-exclusivity occur for CRESEMBA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 07302320
Patent: Active ingredient containing stabilised solid medicinal forms and method for the production thereof
Estimated Expiration: ⤷  Sign Up

Austria

Patent: 59342
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 63941
Patent: FORMES GALENIQUES SOLIDES STABILISEES, ET LEUR PROCEDE DE PRODUCTION (STABILIZED SOLID FORMS AND METHOD FOR THE PRODUCTION THEREOF)
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 68842
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 02708
Patent: Compositions pharmaceutiques stabilisées et solides contenant au moins un médicament et procédé d'élaboration (Drug comprising stabilized pharmaceutical solid compositions and processes for their preparation)
Estimated Expiration: ⤷  Sign Up

Patent: 68842
Patent: FORMES GALÉNIQUES SOLIDES STABILISÉES CONTENANT UN PRINCIPE ACTIF ET DICITRATE DU TRIMAGNÉSIUM COMME DESSICCATEUR ET LEUR PROCÉDÉ DE PRODUCTION (ACTIVE INGREDIENT AND TRIMAGNESIUMDICITRATE AS DESICCANT CONTAINING STABILISED SOLID MEDICINAL FORMS AND METHOD FOR THE PRODUCTION THEREOF)
Estimated Expiration: ⤷  Sign Up

Germany

Patent: 2007003037
Estimated Expiration: ⤷  Sign Up

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering CRESEMBA around the world.

Country Patent Number Title Estimated Expiration
Canada 2663941 FORMES GALENIQUES SOLIDES STABILISEES, ET LEUR PROCEDE DE PRODUCTION (STABILIZED SOLID FORMS AND METHOD FOR THE PRODUCTION THEREOF) ⤷  Sign Up
European Patent Office 1280795 DERIVES CARBAMOYLOXYALKYL-AZOLIUM N-SUBSTITUES (N-SUBSTITUTED CARBAMOYLOXYALKYL-AZOLIUM DERIVATIVES) ⤷  Sign Up
Japan 6956227 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for CRESEMBA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1280795 15C0096 France ⤷  Sign Up PRODUCT NAME: ISAVUCONAZOLE; REGISTRATION NO/DATE: EU/1/15/1036 20151015
1280795 92939 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
1280795 512 Finland ⤷  Sign Up
>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.