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CRESEMBA Drug Patent 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 are three patents protecting this drug and two Paragraph IV challenges.

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.

There are two Paragraph IV patent challenges for this drug. This may lead to patent invalidation or a license for generic production.

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

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for CRESEMBA

Generic Entry Dates for CRESEMBA^: ⤷ Sign Up* 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: 207500 Dosage: CAPSULE;ORAL
Generic Entry Dates for CRESEMBA^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: TREATMENT OF INVASIVE MUCORMYCOSIS IN PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER NDA: 207501 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

Sponsor	Phase
Pfizer	Phase 4
Jeffrey Jenks, MD, MPH	Phase 3
Astellas Pharma Global Development, Inc.	Phase 3

See all CRESEMBA clinical trials

Pharmacology for CRESEMBA

Drug Class	Azole Antifungal
Mechanism of Action	Cytochrome P450 3A4 Inhibitors Organic Cation Transporter 2 Inhibitors P-Glycoprotein Inhibitors

Paragraph IV (Patent) Challenges for CRESEMBA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CRESEMBA	Capsules	isavuconazonium sulfate	186 mg	207500	4	2024-09-06
CRESEMBA	For Injection	isavuconazonium sulfate	372 mg/vial	207501	2	2024-09-06

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

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

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Glossary

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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
Astellas	CRESEMBA	isavuconazonium sulfate	CAPSULE;ORAL	207500-001	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
>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

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

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Country	Patent Number	Title	Estimated Expiration
China	1387529		⤷ Sign Up
China	111052625	下行链路同步 (DOWNLINK SYNCHRONIZATION)	⤷ Sign Up
Japan	2024045231	ダウンリンク同期	⤷ Sign Up
Spain	2238341		⤷ Sign Up
South Africa	200203003	N-substituted carbamoyloxyalkyl-azolium derivatives.	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for CRESEMBA

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1280795	2015/073	Ireland	⤷ Sign Up	PRODUCT NAME: ISAVUCONAZOLE AS ISAVUCONAZONIUM SULFATE OR AS ISAVUCONAZONIUM SALT WITH ANY OTHER PHARMACEUTICALLY ACCEPTABLE ANION, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE, OR SOLVATE; REGISTRATION NO/DATE: EU/1/15/1036 20151015
1280795	15C0096	France	⤷ Sign Up	PRODUCT NAME: ISAVUCONAZOLE; REGISTRATION NO/DATE: EU/1/15/1036 20151015
1280795	5/2016	Austria	⤷ Sign Up	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	122014000122	Germany	⤷ Sign Up	PRODUCT NAME: SITAGLIPTIN IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/07/383/001-018 20070321
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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description