Oritavancin diphosphate - Generic Drug Details

What are the generic drug sources for oritavancin diphosphate and what is the scope of freedom to operate?

Oritavancin diphosphate is the generic ingredient in two branded drugs marketed by Melinta Therap and is included in two NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Oritavancin diphosphate has thirty-nine patent family members in seventeen countries.

One supplier is listed for this compound.

Summary for oritavancin diphosphate

International Patents:	39
US Patents:	3
Tradenames:	2
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	27
Clinical Trials:	4
Patent Applications:	54
What excipients (inactive ingredients) are in oritavancin diphosphate?	oritavancin diphosphate excipients list
DailyMed Link:	oritavancin diphosphate at DailyMed

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

Constraining patent/regulatory exclusivity:

GENERATING ANTIBIOTIC INCENTIVES NOW

Dosage:

POWDER;INTRAVENOUS

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.

Recent Clinical Trials for oritavancin diphosphate

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

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

See all oritavancin diphosphate clinical trials

Pharmacology for oritavancin diphosphate

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 oritavancin diphosphate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Melinta Therap	KIMYRSA	oritavancin diphosphate	POWDER;INTRAVENOUS	214155-001	Mar 12, 2021		RX	Yes	Yes
Melinta Therap	KIMYRSA	oritavancin diphosphate	POWDER;INTRAVENOUS	214155-001	Mar 12, 2021		RX	Yes	Yes
Melinta Therap	ORBACTIV	oritavancin diphosphate	POWDER;INTRAVENOUS	206334-001	Aug 6, 2014		RX	Yes	Yes
Melinta Therap	KIMYRSA	oritavancin diphosphate	POWDER;INTRAVENOUS	214155-001	Mar 12, 2021		RX	Yes	Yes
Melinta Therap	ORBACTIV	oritavancin diphosphate	POWDER;INTRAVENOUS	206334-001	Aug 6, 2014		RX	Yes	Yes
Melinta Therap	KIMYRSA	oritavancin diphosphate	POWDER;INTRAVENOUS	214155-001	Mar 12, 2021		RX	Yes	Yes
Melinta Therap	KIMYRSA	oritavancin diphosphate	POWDER;INTRAVENOUS	214155-001	Mar 12, 2021		RX	Yes	Yes			Y	Y

Expired US Patents for oritavancin diphosphate

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

International Patents for oritavancin diphosphate

Country	Patent Number	Title	Estimated Expiration
Brazil	PI1014767	métodos de tratamento de infecções bacterianas usando oritavancina
Japan	5782615
European Patent Office	3006038	METHODES DE TRAITEMENT UTILISANT DES DOSES UNIQUES D'ORITAVANCINE (METHODS OF TREATMENT USING SINGLE DOSES OF ORITAVANCIN)
Japan	6712991
China	102215858	Methods of treatment using single doses of oritavancin
China	107206050	高纯度奥利万星及其生产方法 (High purity oritavancin and method of producing same)
European Patent Office	2337575	MÉTHODES DE TRAITEMENT UTILISANT DES DOSES UNIQUES D'ORITAVANCINE (METHODS OF TREATMENT USING SINGLE DOSES OF ORITAVANCIN)

Supplementary Protection Certificates for oritavancin diphosphate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2337575	1690041-7	Sweden		PRODUCT NAME: ORITAVANCIN ELLER ETT FARMACEUTISKT GODTAGBART SALT DAERAV; REG. NO/DATE: EU/1/15/989 20150323
2337575	122016000075	Germany		PRODUCT NAME: ORITAVANCIN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/989 20150319
2337575	SPC/GB16/054	United Kingdom		PRODUCT NAME: ORITAVANCIN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, SPECIFICALLY ORITAVANCIN DIPHOSPHATE.; REGISTERED: UK EU/1/15/989/001 20150323
2337575	2016/040	Ireland		PRODUCT NAME: ORITAVANCIN AND PHARMACEUTICAL SALTS THEREOF, E.G DIPHOSPHATE SALTS; REGISTRATION NO/DATE: EU/1/15/989 20150319
2337575	16C0039	France		PRODUCT NAME: ORITAVANCINE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES,TELS QUE LES SELS DIPHOSPHATES; REGISTRATION NO/DATE: EU/1/15/989 20150323
2337575	CA 2016 00044	Denmark		PRODUCT NAME: ORITAVANCIN OG/ELLER FARMACEUTISKE SALTE HERAF, HERUNDER DIFOSFATSALTE; REG. NO/DATE: EU/1/15/989 20150323
2337575	41/2016	Austria		PRODUCT NAME: ORITAVANCIN UND DESSEN PHARMAZEUTISCHE SALZE; REGISTRATION NO/DATE: EU/1/15/989 (MITTEILUNG) 20150323