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

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for 206334

Generic Entry Date for 206334^: See Plans and Pricing* Constraining patent/regulatory exclusivity: GENERATING ANTIBIOTIC INCENTIVES NOW 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
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:	See Plans and Pricing	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	See Plans and Pricing	See Plans and Pricing
Melinta Therap	ORBACTIV	oritavancin diphosphate	POWDER;INTRAVENOUS	206334-001	Aug 6, 2014	See Plans and Pricing	See Plans and Pricing
>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. 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.