Details for New Drug Application (NDA): 209776
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NDA 209776 describes VABOMERE, which is a drug marketed by Rempex 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 VABOMERE profile page.
The generic ingredient in VABOMERE is meropenem; vaborbactam. There are thirty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the meropenem; vaborbactam profile page.
The generic ingredient in VABOMERE is meropenem; vaborbactam. There are thirty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the meropenem; vaborbactam profile page.
Summary for 209776
| Tradename: | VABOMERE |
| Applicant: | Rempex |
| Ingredient: | meropenem; vaborbactam |
| Patents: | 7 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 209776
Generic Entry Date for 209776*:
Constraining patent/regulatory exclusivity:
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: 209776
| Mechanism of Action | beta Lactamase Inhibitors |
Suppliers and Packaging for NDA: 209776
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VABOMERE | meropenem; vaborbactam | POWDER;INTRAVENOUS | 209776 | NDA | Melinta Therapeutics, LLC | 70842-120 | 70842-120-06 | 6 VIAL, SINGLE-DOSE in 1 CARTON (70842-120-06) / 2 g in 1 VIAL, SINGLE-DOSE (70842-120-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | 1GM/VIAL;1GM/VIAL | ||||
| Approval Date: | Aug 29, 2017 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Aug 29, 2027 | ||||||||
| Regulatory Exclusivity Use: | GENERATING ANTIBIOTIC INCENTIVES NOW | ||||||||
| Regulatory Exclusivity Expiration: | Aug 29, 2022 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Aug 8, 2031 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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