ORBACTIV Drug Patent Profile

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.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 29, 2029. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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

See drug prices for ORBACTIV

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

NDA:

206334

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 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.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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
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			Y

Expired US Patents for ORBACTIV

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 ORBACTIV

When does loss-of-exclusivity occur for ORBACTIV?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Canada

China

Denmark

Eurasian Patent Organization

European Patent Office

Hungary

Japan

Mexico

Netherlands

New Zealand

Norway

Poland

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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

Country	Patent Number	Title	Estimated Expiration
Austria	286910
Hungary	225164	GLYCOPEPTIDE ANTIBIOTIC DERIVATIVES, PROCESS FOR THEIR PREPARATION AND PHARMACEUTICAL COMPOSITIONS COMPRISING THEREOF
Israel	129991
South Africa	9710428	Reductive alkylation of glycopeptide antibiotics

Supplementary Protection Certificates for ORBACTIV

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2337575	2016/040	Ireland		PRODUCT NAME: ORITAVANCIN AND PHARMACEUTICAL SALTS THEREOF, E.G DIPHOSPHATE SALTS; REGISTRATION NO/DATE: EU/1/15/989 20150319
2337575	2016019	Norway		PRODUCT NAME: ORITAVANCIN OG FARMASOEYTISK; REG. NO/DATE: EU/1/15/989 20150415
2337575	41/2016	Austria		PRODUCT NAME: ORITAVANCIN UND DESSEN PHARMAZEUTISCHE SALZE; REGISTRATION NO/DATE: EU/1/15/989 (MITTEILUNG) 20150323
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

Market Dynamics and Financial Trajectory for ORBACTIV

Introduction

ORBACTIV (oritavancin) is a lipoglycopeptide antibacterial drug specifically designed for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI), including those caused by methicillin-resistant Staphylococcus aureus (MRSA). Here, we delve into the market dynamics and financial trajectory of ORBACTIV, examining its clinical efficacy, market performance, and the broader financial context.

Clinical Efficacy and Indications

ORBACTIV is indicated for the treatment of ABSSSI caused by susceptible Gram-positive microorganisms. It is administered as a single 1,200 mg dose via intravenous infusion over 3 hours, which distinguishes it from other antibacterial treatments that often require multiple doses[1][3][4].

Market Performance

Comparative Clinical Benefit

Studies have shown that ORBACTIV offers significant clinical benefits, particularly in its efficacy against MRSA and other Gram-positive bacteria. It achieves ≥99.9% killing in vitro within 1 hour, outperforming vancomycin in some aspects[1]. However, the market performance of antimicrobial drugs like ORBACTIV is often influenced by factors such as development costs, regulatory approvals, and market demand.

Sales and Revenue

The sales performance of ORBACTIV is part of a broader trend in the antimicrobial drug market. Antimicrobial drugs generally have lower sales revenues compared to other therapeutic areas like oncology. For instance, the average cumulative 9-quarter sales for the highest-ranking antimicrobial drugs are significantly lower than those for oncology drugs, with antimicrobials averaging around $42 million compared to $1,041 million for oncology drugs[3].

Development and Approval Costs

Despite lower sales, antimicrobial drugs, including ORBACTIV, have relatively lower development and approval costs. The average capitalized development and approval costs for antimicrobial drugs are estimated at $1,508 million, which is less than that for non-antimicrobial comparator and oncology drugs[3].

Financial Trajectory

Development Phase

The development of ORBACTIV involved significant investment and regulatory interactions. After initial setbacks, The Medicines Company, which later became part of Melinta Therapeutics, conducted additional Phase 3 trials to secure FDA approval. The drug was granted QIDP (Qualified Infectious Disease Product) designation, which provided certain incentives and exclusivity benefits[4].

Post-Approval Performance

Since its approval, ORBACTIV has been part of the portfolio of companies involved in the antimicrobial market. The financial performance of these companies can provide insights into the drug's market impact.

Company Financials

Companies like Melinta Therapeutics, which have been involved in the development and marketing of ORBACTIV, have faced challenges in the antimicrobial market. However, specific financial data for ORBACTIV is not always separately disclosed. Instead, we look at broader industry trends and company performance.

For example, Orbia Advance Corporation, while not directly involved in ORBACTIV, operates in related sectors and faces similar market challenges. Orbia's financial results reflect the broader economic and market conditions affecting the healthcare and pharmaceutical sectors. In 2023, Orbia reported a decrease in net revenues and EBITDA, largely due to weak market conditions in construction, infrastructure, and capital investment sectors[2][5].

Safety and Efficacy Profile

Adverse Reactions

ORBACTIV's safety profile includes common adverse reactions such as headache, nausea, vomiting, and diarrhea. It also has specific warnings regarding coagulation test interference and hypersensitivity reactions[1].

Clinical Response Rates

Clinical trials have shown that the efficacy and safety profiles of single-dose ORBACTIV are comparable to those of multidose vancomycin. This includes similar clinical response rates and adverse reaction profiles[1].

Market Dynamics

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of antimicrobial drugs. ORBACTIV's QIDP designation and subsequent FDA approval highlight the regulatory support for innovative antimicrobial treatments. However, the regulatory landscape is constantly evolving, with ongoing discussions about trial design and primary endpoints for serious bacterial infections[4].

Competitive Landscape

The competitive landscape for antimicrobial drugs is characterized by a need for innovative treatments to combat antibiotic resistance. ORBACTIV's single-dose regimen and broad-spectrum activity against Gram-positive bacteria position it as a competitive option in the market[1].

Patient and Healthcare Provider Perspectives

From a patient perspective, the convenience of a single-dose treatment can significantly improve adherence and outcomes. For healthcare providers, ORBACTIV offers a potent tool in managing ABSSSI, particularly in cases where MRSA is suspected or confirmed[1].

Financial Implications for Healthcare Systems

Cost of Treatment

The cost of treatment with ORBACTIV, while significant, can be offset by reduced hospital stay times and lower readmission rates. For example, ABSSSI is one of the top reasons for hospital admissions from the Emergency Department, and effective treatment can reduce the average length of stay and readmission rates[1].

Economic Impact

The economic impact of ORBACTIV extends beyond direct treatment costs. By reducing the burden of ABSSSI on healthcare systems, it can help in managing overall healthcare expenditures. However, the broader economic conditions, such as those affecting Orbia and similar companies, can influence the availability and affordability of such treatments[2][5].

Key Takeaways

• Clinical Efficacy: ORBACTIV is highly effective against ABSSSI, including MRSA, with a single-dose regimen.
• Market Performance: Antimicrobial drugs like ORBACTIV have lower sales revenues but lower development costs compared to other therapeutic areas.
• Financial Trajectory: The financial performance of companies involved in the antimicrobial market is influenced by broader economic and market conditions.
• Safety and Efficacy: ORBACTIV has a comparable safety and efficacy profile to vancomycin, with specific warnings and adverse reactions.
• Market Dynamics: The regulatory environment, competitive landscape, and patient perspectives all play critical roles in the market dynamics of ORBACTIV.

FAQs

What is ORBACTIV used for?

ORBACTIV is used for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI), including those caused by methicillin-resistant Staphylococcus aureus (MRSA)[1].

How is ORBACTIV administered?

ORBACTIV is administered as a single 1,200 mg dose via intravenous infusion over 3 hours[1].

What are the common adverse reactions associated with ORBACTIV?

Common adverse reactions include headache, nausea, vomiting, limb and subcutaneous abscesses, and diarrhea[1].

How does ORBACTIV compare to vancomycin in clinical trials?

ORBACTIV has shown comparable efficacy and safety profiles to vancomycin in clinical trials, with similar clinical response rates and adverse reaction profiles[1].

What is the regulatory status of ORBACTIV?

ORBACTIV has been granted QIDP (Qualified Infectious Disease Product) designation and has received FDA approval for the treatment of ABSSSI[4].