ISAVUCONAZONIUM SULFATE - Generic Drug Details
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What are the generic drug sources for isavuconazonium sulfate and what is the scope of freedom to operate?
Isavuconazonium sulfate
is the generic ingredient in one branded drug marketed by Astellas and is included in two NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.Isavuconazonium sulfate has thirty-two patent family members in nineteen countries.
One supplier is listed for this compound.
Summary for ISAVUCONAZONIUM SULFATE
International Patents: | 32 |
US Patents: | 3 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 34 |
Clinical Trials: | 8 |
Patent Applications: | 52 |
What excipients (inactive ingredients) are in ISAVUCONAZONIUM SULFATE? | ISAVUCONAZONIUM SULFATE excipients list |
DailyMed Link: | ISAVUCONAZONIUM SULFATE at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ISAVUCONAZONIUM SULFATE
Generic Entry Dates for ISAVUCONAZONIUM SULFATE*:
Constraining patent/regulatory exclusivity:
TREATMENT OF INVASIVE ASPERGILLOSIS IN PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER WHO WEIGH 16 KILOGRAMS (KG) AND GREATER Dosage:
CAPSULE;ORAL |
Generic Entry Dates for ISAVUCONAZONIUM SULFATE*:
Constraining patent/regulatory exclusivity:
TREATMENT OF INVASIVE MUCORMYCOSIS IN PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER 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 ISAVUCONAZONIUM SULFATE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Jeffrey Jenks, MD, MPH | Phase 3 |
Astellas Pharma Global Development, Inc. | Phase 3 |
Astellas Pharma Global Development, Inc. | Phase 2 |
Pharmacology for ISAVUCONAZONIUM SULFATE
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 ISAVUCONAZONIUM SULFATE
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 | ⤷ 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 | POWDER;INTRAVENOUS | 207501-001 | 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 |
Expired US Patents for ISAVUCONAZONIUM SULFATE
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 ISAVUCONAZONIUM SULFATE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Portugal | 1280795 | ⤷ Sign Up | |
Brazil | 0015254 | compostos derivados de carbamoiloxialquil-azàlio, seu uso, bem como composiÇço farmacÊutica compreendendo os mesmos. | ⤷ Sign Up |
Germany | 60018989 | ⤷ Sign Up | |
Brazil | PI0015254 | compostos derivados de carbamoiloxialquil-azólio, seu uso, bem como composição farmacêutica compreendendo os mesmos. | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ISAVUCONAZONIUM SULFATE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1280795 | 1690011-0 | Sweden | ⤷ Sign Up | PRODUCT NAME: ISAVUCONAZOLE; REG. NO/DATE: EU/1/15/1036 20151016 |
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 | CR 2016 00002 | Denmark | ⤷ Sign Up | 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 | 15C0096 | France | ⤷ Sign Up | PRODUCT NAME: ISAVUCONAZOLE; REGISTRATION NO/DATE: EU/1/15/1036 20151015 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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