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Generated: November 14, 2018

DrugPatentWatch Database Preview

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

The generic ingredient in ORBACTIV is oritavancin diphosphate. Two suppliers are 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
Generic Entry Opportunity Date for 206334
Generic Entry Date for 206334*:
Constraining patent/regulatory exclusivity:
GENERATING ANTIBIOTIC INCENTIVES NOW
Dosage:
POWDER;IV (INFUSION)

*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: 206334
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ORBACTIV oritavancin diphosphate POWDER;INTRAVENOUS 206334 NDA The Medicines Company 65293-015 65293-015-03 3 VIAL, GLASS in 1 CARTON (65293-015-03) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS (65293-015-01)
ORBACTIV oritavancin diphosphate POWDER;INTRAVENOUS 206334 NDA Melinta Therapeutics, Inc. 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:RXDosage:POWDER;INTRAVENOUSStrengthEQ 400MG BASE/VIAL
Approval Date:Aug 6, 2014TE: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 UpPatent Expiration:Nov 24, 2020Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS

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Serving hundreds of leading biopharmaceutical companies globally:

Healthtrust
McKesson
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Deloitte
QuintilesIMS
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Johnson and Johnson

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