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 forty-six patent family members in nineteen countries.

One supplier is listed for this compound.

Summary for oritavancin diphosphate

International Patents:	46
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

Dosage:

POWDER;INTRAVENOUS

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

Anatomical Therapeutic Chemical (ATC) Classes for oritavancin diphosphate

J01XA	Glycopeptide antibacterials
J01X	OTHER ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

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	ORBACTIV	oritavancin diphosphate	POWDER;INTRAVENOUS	206334-001	Aug 6, 2014		RX	Yes	Yes			Y
Melinta Therap	ORBACTIV	oritavancin diphosphate	POWDER;INTRAVENOUS	206334-001	Aug 6, 2014		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
Australia	2010245097	Methods of treating bacterial infections using oritavancin
China	102573882	Methods of treating bacterial infections using oritavancin
Hungary	S1600039
Hungary	E068423
Denmark	3006038

Supplementary Protection Certificates for oritavancin diphosphate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2337575	2016019	Norway		PRODUCT NAME: ORITAVANCIN OG FARMASOEYTISK; REG. NO/DATE: EU/1/15/989 20150415
2337575	2016/040	Ireland		PRODUCT NAME: ORITAVANCIN AND PHARMACEUTICAL SALTS THEREOF, E.G DIPHOSPHATE SALTS; REGISTRATION NO/DATE: EU/1/15/989 20150319
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	1690041-7	Sweden		PRODUCT NAME: ORITAVANCIN ELLER ETT FARMACEUTISKT GODTAGBART SALT DAERAV; FIRST MARKETING AUTHORIZATION NUMBER SE: EU/1/15/989, 2015-03-23

Market Dynamics and Financial Trajectory for Oritavancin Diphosphate

Introduction

Oritavancin diphosphate, marketed under the names ORBACTIV and Kimyrsa, is a lipoglycopeptide antibacterial agent approved by the FDA for the treatment of acute bacterial skin and skin structure infections (ABSSSI). Here, we delve into the market dynamics and financial trajectory of this drug.

Mechanism and Approval

Oritavancin diphosphate was initially approved by the FDA in 2014 for the treatment of ABSSSI, with a mechanism of action similar to that of vancomycin. It is administered as a single 1200 mg dose via intravenous infusion, either over 3 hours (ORBACTIV) or 1 hour (Kimyrsa, approved in 2021)[1][4].

Clinical Efficacy and Safety

The drug has demonstrated substantial evidence of efficacy in treating ABSSSI, with clinical trials showing non-inferiority to vancomycin. The safety profile of oritavancin is generally similar to that of vancomycin, although there are notable interactions, such as a weak inhibition of CYP2C9 and a weak induction of CYP3A4, which can affect the metabolism of certain drugs like warfarin[1].

Market Impact

Economic Outcomes

Studies have shown that oritavancin can significantly reduce hospital costs and improve clinical outcomes. A retrospective study at DeTar Healthcare System found that patients treated with oritavancin had lower readmission rates at 30 and 90 days compared to those treated with other antibiotics. This resulted in a significant cost avoidance, estimated at $207,423.64 per 100 patients, primarily due to reduced average length of stay and lower readmission rates[2].

Hospital Cost Savings

The ability to treat ABSSSI patients with oritavancin in an outpatient setting or with early discharge has been highlighted as a key factor in reducing hospital costs. By avoiding inpatient admissions, hospitals can save between $13,090 to $13,473 per patient, which is crucial given the increasing rates of ABSSSI and the pressure on hospital operating margins[2].

Development and Approval Costs

Oritavancin diphosphate, like other antibacterial drugs, has significant development and approval costs. However, when compared to non-antibacterial and oncology drugs, the costs are relatively lower. The average capitalized development and approval costs for antibacterial drugs, including oritavancin, are estimated to be around $1.508 billion, which is less than the costs for non-antibacterial and oncology drugs[3].

Market Sales and Performance

The market performance of oritavancin is influenced by its comparative added clinical benefit. Drugs with higher clinical benefit scores tend to have higher early market sales. While oritavancin's sales are not as high as those of oncology drugs, it still benefits from its unique single-dose administration and non-inferiority to vancomycin, which are attractive features in the treatment of ABSSSI[3].

Competitive Landscape

Oritavancin operates in a competitive market for antibacterial agents, particularly those targeting Gram-positive bacteria. Its single-dose regimen and efficacy against methicillin-resistant Staphylococcus aureus (MRSA) make it a valuable option for clinicians. However, it must compete with other antibiotics, including vancomycin, which has a well-established market presence[1][4].

Regulatory and Labeling Considerations

The FDA approval process for oritavancin included careful evaluation of its safety and efficacy. The drug's labeling includes warnings about potential interactions, such as the increased exposure to warfarin, which is metabolized by CYP2C9. These considerations are crucial for ensuring the safe use of oritavancin in clinical practice[1].

Real-World Experience and Utilization

Real-world studies have supported the clinical and economic benefits of oritavancin. For instance, the development of an oritavancin protocol at DeTar Healthcare System led to improved patient outcomes and cost savings. Such real-world data is essential for informing treatment guidelines and hospital policies[2].

Future Prospects

Given its clinical efficacy, safety profile, and economic benefits, oritavancin diphosphate is likely to continue playing a significant role in the treatment of ABSSSI. As hospitals and healthcare systems seek to optimize resource use and reduce costs, drugs like oritavancin that offer efficient and effective treatment options will remain valuable.

Key Takeaways

• Clinical Efficacy: Oritavancin diphosphate is non-inferior to vancomycin in treating ABSSSI.
• Economic Benefits: Reduces hospital costs through lower readmission rates and shorter lengths of stay.
• Development Costs: Lower compared to non-antibacterial and oncology drugs.
• Market Performance: Benefits from its single-dose regimen and comparative clinical benefit.
• Regulatory Considerations: Includes warnings about potential drug interactions.

FAQs

Q: What is the primary indication for oritavancin diphosphate? A: Oritavancin diphosphate is primarily indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI).

Q: How is oritavancin diphosphate administered? A: It is administered as a single 1200 mg dose via intravenous infusion, either over 3 hours (ORBACTIV) or 1 hour (Kimyrsa).

Q: What are the notable safety considerations for oritavancin diphosphate? A: Notable safety considerations include potential interactions with warfarin and other drugs metabolized by CYP2C9, as well as the risk of adverse events such as sepsis and osteomyelitis.

Q: How does oritavancin diphosphate impact hospital costs? A: Oritavancin diphosphate can significantly reduce hospital costs by decreasing average length of stay and readmission rates for ABSSSI patients.

Q: What is the comparative market performance of oritavancin diphosphate? A: While its sales are not as high as those of oncology drugs, oritavancin benefits from its unique single-dose administration and non-inferiority to vancomycin, making it a valuable option in the antibacterial market.

Sources

1. FDA Office Director Memo: NDA 206,334 Oritavancin diphosphate for injection[1].
2. PLOS ONE: Improved economic and clinical outcomes with oritavancin versus a comparator group in patients with skin and skin structure infections[2].
3. ASPE Report: An Analysis of Antibacterial Drug Development Trends in the United States[3].
4. DrugBank Online: Oritavancin diphosphate[4].