Details for New Drug Application (NDA): 217417
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NDA 217417 describes REZZAYO, which is a drug marketed by Mundipharma and is included in one NDA. It is available from one supplier. There are seven patents protecting this drug. Additional details are available on the REZZAYO profile page.
The generic ingredient in REZZAYO is rezafungin acetate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the rezafungin acetate profile page.
The generic ingredient in REZZAYO is rezafungin acetate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the rezafungin acetate profile page.
Summary for 217417
| Tradename: | REZZAYO |
| Applicant: | Mundipharma |
| Ingredient: | rezafungin acetate |
| Patents: | 7 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 217417
Generic Entry Date for 217417*:
Constraining patent/regulatory exclusivity:
GENERATING ANTIBIOTIC INCENTIVES NOW 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.
Pharmacology for NDA: 217417
Suppliers and Packaging for NDA: 217417
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| REZZAYO | rezafungin acetate | POWDER;INTRAVENOUS | 217417 | NDA | Melinta Therapeutics, LLC | 70842-240 | 70842-240-01 | 1 VIAL in 1 CARTON (70842-240-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | EQ 200MG BASE/VIAL | ||||
| Approval Date: | Mar 22, 2023 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Mar 22, 2030 | ||||||||
| Regulatory Exclusivity Use: | FOR USE IN PATIENTS 18 YEARS OF AGE OR OLDER WHO HAVE LIMITED OR NO ALTERNATIVE OPTIONS FOR THE TREATMENT OF CANDIDEMIA AND INVASIVE CANDIDIASIS | ||||||||
| Regulatory Exclusivity Expiration: | Mar 22, 2033 | ||||||||
| Regulatory Exclusivity Use: | GENERATING ANTIBIOTIC INCENTIVES NOW | ||||||||
| Regulatory Exclusivity Expiration: | Mar 22, 2035 | ||||||||
| Regulatory Exclusivity Use: | GENERATING ANTIBIOTIC INCENTIVES NOW | ||||||||
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