Details for New Drug Application (NDA): 207500
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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 207500
Tradename: | CRESEMBA |
Applicant: | Astellas |
Ingredient: | isavuconazonium sulfate |
Patents: | 3 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 207500
Generic Entry Date for 207500*:
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 |
*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.
Pharmacology for NDA: 207500
Suppliers and Packaging for NDA: 207500
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CRESEMBA | isavuconazonium sulfate | CAPSULE;ORAL | 207500 | NDA | Astellas Pharma US, Inc. | 0469-0520 | 0469-0520-14 | 4 CARTON in 1 CARTON (0469-0520-14) / 14 BLISTER PACK in 1 CARTON (0469-0520-02) / 1 CAPSULE in 1 BLISTER PACK |
CRESEMBA | isavuconazonium sulfate | CAPSULE;ORAL | 207500 | NDA | Astellas Pharma US, Inc. | 0469-2860 | 0469-2860-35 | 35 BLISTER PACK in 1 CARTON (0469-2860-35) / 1 CAPSULE in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 186MG | ||||
Approval Date: | Mar 6, 2015 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | Sep 6, 2025 | ||||||||
Regulatory Exclusivity Use: | GENERATING ANTIBIOTIC INCENTIVES NOW | ||||||||
Regulatory Exclusivity Expiration: | Sep 6, 2027 | ||||||||
Regulatory Exclusivity Use: | GENERATING ANTIBIOTIC INCENTIVES NOW | ||||||||
Regulatory Exclusivity Expiration: | Mar 6, 2020 | ||||||||
Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY |
Expired US Patents for NDA 207500
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Astellas | CRESEMBA | isavuconazonium sulfate | CAPSULE;ORAL | 207500-001 | Mar 6, 2015 | ⤷ Subscribe | ⤷ Subscribe |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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