You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 23, 2024

ORITAVANCIN DIPHOSPHATE - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


What are the generic sources for oritavancin diphosphate and what is the scope of patent protection?

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
Recent Clinical Trials for ORITAVANCIN DIPHOSPHATE

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

SponsorPhase
Melinta Therapeutics, Inc.Phase 2
The Medicines CompanyPhase 1

See all ORITAVANCIN DIPHOSPHATE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for ORITAVANCIN DIPHOSPHATE

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 ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Melinta Therap KIMYRSA oritavancin diphosphate POWDER;INTRAVENOUS 214155-001 Mar 12, 2021 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Melinta Therap KIMYRSA oritavancin diphosphate POWDER;INTRAVENOUS 214155-001 Mar 12, 2021 RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y Y ⤷  Subscribe
Melinta Therap ORBACTIV oritavancin diphosphate POWDER;INTRAVENOUS 206334-001 Aug 6, 2014 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Melinta Therap KIMYRSA oritavancin diphosphate POWDER;INTRAVENOUS 214155-001 Mar 12, 2021 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>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 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 ⤷  Subscribe ⤷  Subscribe
Melinta Therap ORBACTIV oritavancin diphosphate POWDER;INTRAVENOUS 206334-001 Aug 6, 2014 ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for ORITAVANCIN DIPHOSPHATE

Country Patent Number Title Estimated Expiration
China 106620649 使用单剂量奥利万星的治疗方法 (Methods of treatment using single doses of oritavancin) ⤷  Subscribe
European Patent Office 3006038 METHODES DE TRAITEMENT UTILISANT DES DOSES UNIQUES D'ORITAVANCINE (METHODS OF TREATMENT USING SINGLE DOSES OF ORITAVANCIN) ⤷  Subscribe
Mexico 2011002249 METODOS DE TRATAMIENTO UTILIZANDO DOSIS UNICAS DE ORITAVANCINA. (METHODS OF TREATMENT USING SINGLE DOSES OF ORITAVANCIN.) ⤷  Subscribe
Eurasian Patent Organization 201700019 ВЫСОКОЧИСТЫЙ ОРИТАВАНЦИН И СПОСОБ ЕГО ПОЛУЧЕНИЯ ⤷  Subscribe
Spain 2570401 ⤷  Subscribe
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ORITAVANCIN DIPHOSPHATE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2337575 2016/040 Ireland ⤷  Subscribe PRODUCT NAME: ORITAVANCIN AND PHARMACEUTICAL SALTS THEREOF, E.G DIPHOSPHATE SALTS; REGISTRATION NO/DATE: EU/1/15/989 20150319
2337575 CA 2016 00044 Denmark ⤷  Subscribe PRODUCT NAME: ORITAVANCIN OG/ELLER FARMACEUTISKE SALTE HERAF, HERUNDER DIFOSFATSALTE; REG. NO/DATE: EU/1/15/989 20150323
2337575 41/2016 Austria ⤷  Subscribe PRODUCT NAME: ORITAVANCIN UND DESSEN PHARMAZEUTISCHE SALZE; REGISTRATION NO/DATE: EU/1/15/989 (MITTEILUNG) 20150323
2337575 SPC/GB16/054 United Kingdom ⤷  Subscribe PRODUCT NAME: ORITAVANCIN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, SPECIFICALLY ORITAVANCIN DIPHOSPHATE.; REGISTERED: UK EU/1/15/989/001 20150323
2337575 300834 Netherlands ⤷  Subscribe PRODUCT NAME: ORITAVANCIN; REGISTRATION NO/DATE: EU/1/15/989 20150323
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

ORITAVANCIN DIPHOSPHATE Market Analysis and Financial Projection Experimental

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].

More… ↓

⤷  Subscribe

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

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.