Details for New Drug Application (NDA): 219491
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NDA 219491 describes NUZOLVENCE, which is a drug marketed by Entasis Therap and is included in one NDA. It is available from one supplier. There are six patents protecting this drug. Additional details are available on the NUZOLVENCE profile page.
The generic ingredient in NUZOLVENCE is zoliflodacin. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the zoliflodacin profile page.
The generic ingredient in NUZOLVENCE is zoliflodacin. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the zoliflodacin profile page.
Summary for 219491
| Tradename: | NUZOLVENCE |
| Applicant: | Entasis Therap |
| Ingredient: | zoliflodacin |
| Patents: | 6 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 219491
Generic Entry Date for 219491*:
Constraining patent/regulatory exclusivity:
GENERATING ANTIBIOTIC INCENTIVES NOW Dosage:
FOR SUSPENSION;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.
Suppliers and Packaging for NDA: 219491
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NUZOLVENCE | zoliflodacin | FOR SUSPENSION;ORAL | 219491 | NDA | La Jolla Pharmaceutical Company | 68547-915 | 68547-915-10 | 1 PACKET in 1 CARTON (68547-915-10) / 1 FOR SUSPENSION in 1 PACKET |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 3GM/PACKET | ||||
| Approval Date: | Dec 12, 2025 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Dec 12, 2035 | ||||||||
| Regulatory Exclusivity Use: | GENERATING ANTIBIOTIC INCENTIVES NOW | ||||||||
| Regulatory Exclusivity Expiration: | Dec 12, 2030 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Jun 20, 2030 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
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