Last Updated: November 8, 2026

Details for New Drug Application (NDA): 206334

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 four patents protecting this drug. Additional details are available on the ORBACTIV profile page.

The generic ingredient in ORBACTIV is oritavancin diphosphate. There is one drug master file entry for this compound. 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:	4

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 206334

Generic Entry Date for 206334^: ⤷ Start Trial* Constraining patent/regulatory exclusivity: 8,420,592 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: 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
Patent:	12,514,899	Patent Expiration:	Aug 29, 2029	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS CAUSED BY STREPTOCOCCUS DYSGALACTIAE WITH A SINGLE DOSE OF 1200MG ORITAVANCIN OR ITS SINGLE DOSE EQUIVALENT
Patent:	8,420,592	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
Patent:	9,649,352	Patent Expiration:	Jul 16, 2035	Product Flag?	Y	Substance Flag?		Delist Request?

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	5,840,684	⤷ Start Trial
Melinta Therap	ORBACTIV	oritavancin diphosphate	POWDER;INTRAVENOUS	206334-001	Aug 6, 2014	5,998,581	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.