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ORBACTIV Drug Patent Profile

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Which patents cover Orbactiv, and what generic alternatives are available?

Orbactiv is a drug marketed by Melinta Therap and is included in one NDA. There are three patents protecting this drug.

This drug has thirty-nine patent family members in seventeen countries.

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.

DrugPatentWatch^® Generic Entry Outlook for Orbactiv

Orbactiv was eligible for patent challenges on August 6, 2018.

Indicators of Generic Entry

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Summary for ORBACTIV

International Patents:	39
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	27
Clinical Trials:	7
Patent Applications:	25
Drug Prices:	Drug price information for ORBACTIV
What excipients (inactive ingredients) are in ORBACTIV?	ORBACTIV excipients list
DailyMed Link:	ORBACTIV at DailyMed

Drug patent expirations by year for ORBACTIV

Recent Clinical Trials for ORBACTIV

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Melinta Therapeutics, Inc.	Phase 2
Melinta Therapeutics, Inc.	Phase 1
The Medicines Company	Phase 4

See all ORBACTIV clinical trials

Pharmacology for ORBACTIV

Drug Class	Lipoglycopeptide Antibacterial
Mechanism of Action	Cytochrome P450 2C19 Inhibitors Cytochrome P450 2C9 Inhibitors Cytochrome P450 2D6 Inducers Cytochrome P450 3A4 Inducers

US Patents and Regulatory Information for ORBACTIV

ORBACTIV is protected by three US patents and two FDA Regulatory Exclusivities.

Patents protecting ORBACTIV

Methods of treatment using single doses of oritavancin
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS USING A SINGLE DOSE

High purity oritavancin and method of producing same
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Methods of treating bacterial infections using oritavancin
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS

FDA Regulatory Exclusivity protecting ORBACTIV

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up

GENERATING ANTIBIOTIC INCENTIVES NOW
Exclusivity Expiration: ⤷ Sign Up

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Melinta Therap	ORBACTIV	oritavancin diphosphate	POWDER;INTRAVENOUS	206334-001	Aug 6, 2014		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Melinta Therap	ORBACTIV	oritavancin diphosphate	POWDER;INTRAVENOUS	206334-001	Aug 6, 2014		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Melinta Therap	ORBACTIV	oritavancin diphosphate	POWDER;INTRAVENOUS	206334-001	Aug 6, 2014		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for ORBACTIV

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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

International Patents for ORBACTIV

See the table below for patents covering ORBACTIV around the world.

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	3006038	METHODES DE TRAITEMENT UTILISANT DES DOSES UNIQUES D'ORITAVANCINE (METHODS OF TREATMENT USING SINGLE DOSES OF ORITAVANCIN)	⤷ Sign Up
European Patent Office	0845478	Alkylation réductrice d'antibiotiques glycopeptidiques (Reductive alkylation of glycopeptide antibiotics)	⤷ Sign Up
Colombia	4650045	ALQUILACION REDUCTIVA DE ANTIBIOTICOS GLICOPEPTIDOS	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for ORBACTIV

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2337575	300834	Netherlands	⤷ Sign Up	PRODUCT NAME: ORITAVANCIN; REGISTRATION NO/DATE: EU/1/15/989 20150323
2337575	132016000101430	Italy	⤷ Sign Up	PRODUCT NAME: ORITAVANCINA E I SUOI SALI DI ADDIZIONE FARMACEUTICAMENTE ACCETTABILI, IN PARTICOLARE IL DIFOSFATO(ORBACTIV); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/989, 20150323
2337575	41/2016	Austria	⤷ Sign Up	PRODUCT NAME: ORITAVANCIN UND DESSEN PHARMAZEUTISCHE SALZE; REGISTRATION NO/DATE: EU/1/15/989 (MITTEILUNG) 20150323
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description