Upgrade for Complete Access See Plans and Pricing

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Johnson and Johnson
Moodys
McKesson
Merck
McKinsey

Last Updated: November 30, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206334


Email this page to a colleague

« Back to Dashboard

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*:
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.

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: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:⤷  Free Forever TrialPatent Expiration:Aug 29, 2029Product 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

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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Colorcon
Merck
AstraZeneca
Boehringer Ingelheim
Moodys
Dow

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.