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Last Updated: June 28, 2022

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 six 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.
Summary for 209776
Ingredient:meropenem; vaborbactam
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 209776
Generic Entry Date for 209776*:
Constraining patent/regulatory exclusivity:

*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:RXDosage:POWDER;INTRAVENOUSStrength1GM/VIAL;1GM/VIAL
Approval Date:Aug 29, 2017TE:RLD:Yes
Regulatory Exclusivity Expiration:Aug 29, 2027
Regulatory Exclusivity Expiration:Aug 29, 2022
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:See Plans and PricingPatent Expiration:Aug 8, 2031Product Flag?YSubstance Flag?Delist Request?

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Johnson and Johnson

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