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Last Updated: December 6, 2022

Details for New Drug Application (NDA): 214155

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NDA 214155 describes KIMYRSA, which is a drug marketed by Melinta Therap and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the KIMYRSA profile page.

The generic ingredient in KIMYRSA is oritavancin diphosphate. One supplier is listed for this compound. Additional details are available on the oritavancin diphosphate profile page.
Summary for 214155
Applicant:Melinta Therap
Ingredient:oritavancin diphosphate
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 214155
Generic Entry Date for 214155*:
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.

Suppliers and Packaging for NDA: 214155
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KIMYRSA oritavancin diphosphate POWDER;INTRAVENOUS 214155 NDA Melinta Therapeutics, LLC 70842-225 70842-225-01 1 VIAL in 1 CARTON (70842-225-01) > 40 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAVENOUSStrengthEQ 1.2GM BASE/VIAL
Approval Date:Mar 12, 2021TE:RLD:Yes
Regulatory Exclusivity Expiration:Aug 6, 2024
Regulatory Exclusivity Expiration:Aug 6, 2019
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Mar 12, 2024
Regulatory Exclusivity Use:NEW PRODUCT

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Johnson and Johnson

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