Details for New Drug Application (NDA): 206334

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NDA 206334 describes ORBACTIV, 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 ORBACTIV profile page.

The generic ingredient in ORBACTIV is oritavancin diphosphate. One supplier is listed for this compound. Additional details are available on the oritavancin diphosphate profile page.

Summary for 206334

Tradename:	ORBACTIV
Applicant:	Melinta Therap
Ingredient:	oritavancin diphosphate
Patents:	3

Pharmacology for NDA: 206334

Mechanism of Action	Cytochrome P450 2C19 Inhibitors Cytochrome P450 2C9 Inhibitors Cytochrome P450 2D6 Inducers Cytochrome P450 3A4 Inducers

Suppliers and Packaging for NDA: 206334

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ORBACTIV	oritavancin diphosphate	POWDER;INTRAVENOUS	206334	NDA	Melinta Therapeutics, LLC	70842-140	70842-140-03	3 VIAL, GLASS in 1 CARTON (70842-140-03) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS (70842-140-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INTRAVENOUS			Strength	EQ 400MG BASE/VIAL
Approval Date:	Aug 6, 2014	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Aug 6, 2024
Regulatory Exclusivity Use:	GENERATING ANTIBIOTIC INCENTIVES NOW
Regulatory Exclusivity Expiration:	Aug 6, 2019
Regulatory Exclusivity Use:	NEW CHEMICAL ENTITY
Patent:	⤷ Sign Up	Patent Expiration:	Aug 29, 2029	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS USING A SINGLE DOSE

Expired US Patents for NDA 206334

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Melinta Therap	ORBACTIV	oritavancin diphosphate	POWDER;INTRAVENOUS	206334-001	Aug 6, 2014	⤷ Sign Up	⤷ Sign Up
Melinta Therap	ORBACTIV	oritavancin diphosphate	POWDER;INTRAVENOUS	206334-001	Aug 6, 2014	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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