CRESEMBA Drug Patent Profile
✉ Email this page to a colleague
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
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 |
Patent Applications: | 28 |
Drug Prices: | Drug price information for CRESEMBA |
What excipients (inactive ingredients) are in CRESEMBA? | CRESEMBA excipients list |
DailyMed Link: | CRESEMBA at DailyMed |
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
Sponsor | Phase |
---|---|
Pfizer | Phase 4 |
Jeffrey Jenks, MD, MPH | Phase 3 |
Astellas Pharma Global Development, Inc. | Phase 3 |
Pharmacology for CRESEMBA
Drug Class | Azole Antifungal |
Mechanism of Action | Cytochrome P450 3A4 Inhibitors Organic Cation Transporter 2 Inhibitors P-Glycoprotein Inhibitors |
US Patents and Regulatory Information for CRESEMBA
CRESEMBA is protected by three US patents and thirteen FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of CRESEMBA is ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Active ingredient containing stabilised solid medicinal forms and methods for the production thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
N-substituted carbamoyloxyalkyl-azolium derivatives
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Try a Trial
NEW PATIENT POPULATION
Exclusivity Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
TREATMENT OF INVASIVE MUCORMYCOSIS IN PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER WHO WEIGH 16 KG AND GREATER
Exclusivity Expiration: ⤷ Try a Trial
PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷ Try a Trial
GENERATING ANTIBIOTIC INCENTIVES NOW
Exclusivity Expiration: ⤷ Try a Trial
GENERATING ANTIBIOTIC INCENTIVES NOW
Exclusivity Expiration: ⤷ Try a Trial
TREATMENT OF INVASIVE MUCORMYCOSIS IN PATIENTS 18 YEARS OF AGE AND OLDER
Exclusivity Expiration: ⤷ Try a Trial
TREATMENT OF INVASIVE ASPERGILLOSIS
Exclusivity Expiration: ⤷ Try a Trial
TREATMENT OF INVASIVE MUCORMYCOSIS IN PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER
Exclusivity Expiration: ⤷ Try a Trial
TREATMENT OF INVASIVE ASPERGILLOSIS IN PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER
Exclusivity Expiration: ⤷ Try a Trial
PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷ Try a Trial
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 a Trial | ⤷ Try a Trial |
Astellas | CRESEMBA | isavuconazonium sulfate | POWDER;INTRAVENOUS | 207501-001 | Mar 6, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
>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
Estimated Expiration: ⤷ Try a Trial
Austria
Patent: 59342
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 63941
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 68842
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 02708
Estimated Expiration: ⤷ Try a Trial
Patent: 68842
Estimated Expiration: ⤷ Try a Trial
Germany
Patent: 2007003037
Estimated Expiration: ⤷ Try a Trial
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 |
---|---|---|---|
Brazil | 0015254 | compostos derivados de carbamoiloxialquil-azàlio, seu uso, bem como composiÇço farmacÊutica compreendendo os mesmos. | ⤷ Try a Trial |
South Korea | 20190039223 | 뉴 라디오를 위한 유연한 프레임 구조에서의 빔포밍 스위핑 및 트레이닝 | ⤷ Try a Trial |
Japan | 6692936 | ⤷ Try a Trial | |
European Patent Office | 3472961 | SIGNALISATION DE COMMANDE DE TÉLÉCHARGEMENT AMONT POUR UNE NOUVELLE RADIO (UPLOAD CONTROL SIGNALING FOR NEW RADIO) | ⤷ Try a Trial |
South Korea | 20190020047 | 뉴 라디오에 대한 그랜트리스 업링크 전송 | ⤷ Try a Trial |
European Patent Office | 3455985 | NOUVEAU CANAL DE COMMANDE DE LIAISON DESCENDANTE RADIO (NEW RADIO DOWNLINK CONTROL CHANNEL) | ⤷ Try a Trial |
Japan | 3787307 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for CRESEMBA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1280795 | 5/2016 | Austria | ⤷ Try a 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 | 512 | Finland | ⤷ Try a Trial | |
1280795 | CA 2016 00002 | Denmark | ⤷ Try a 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 |
1280795 | 2015/073 | Ireland | ⤷ Try a Trial | 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 | 122016000011 | Germany | ⤷ Try a Trial | 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 |
1280795 | CR 2016 00002 | Denmark | ⤷ Try a 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 |
1280795 | 300791 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: ISAVUCONAZOL ALS ISAVUCONAZONIUM SULFAAT OF ALS EEN ISAVUCONAZONIUM ZOUT MET ELK ANDER FARMACEUTISCH AANVAARDBAAR ANION, NAAR KEUZE IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, HYDRAAT OF SOLVAAT; REGISTRATION NO/DATE: EU/1/15/1036 20151019 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |