Details for New Drug Application (NDA): 218275
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NDA 218275 describes ZEVTERA, which is a drug marketed by Istx and is included in one NDA. It is available from one supplier. Additional details are available on the ZEVTERA profile page.
The generic ingredient in ZEVTERA is ceftobiprole medocaril sodium. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the ceftobiprole medocaril sodium profile page.
The generic ingredient in ZEVTERA is ceftobiprole medocaril sodium. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the ceftobiprole medocaril sodium profile page.
Summary for 218275
| Tradename: | ZEVTERA |
| Applicant: | Istx |
| Ingredient: | ceftobiprole medocaril sodium |
| Patents: | 0 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 218275
Generic Entry Date for 218275*:
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: 218275
Suppliers and Packaging for NDA: 218275
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ZEVTERA | ceftobiprole medocaril sodium | POWDER;INTRAVENOUS | 218275 | NDA | La Jolla Pharmaceutical Company | 68547-578 | 68547-578-10 | 10 VIAL, GLASS in 1 BOX (68547-578-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (68547-578-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | 667MG/VIAL | ||||
| Approval Date: | Apr 3, 2024 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Apr 3, 2034 | ||||||||
| Regulatory Exclusivity Use: | GENERATING ANTIBIOTIC INCENTIVES NOW | ||||||||
| Regulatory Exclusivity Expiration: | Apr 3, 2029 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
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