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Oritavancin | CAS No: 171099-57-3 | GMP-certified suppliers
A medication that treats acute bacterial skin and skin structure infections caused by susceptible gram-positive organisms in adult patients, supporting improved treatment compliance.
Therapeutic categories
Primary indications
- Oritavancin is indicated for the treatment of adult patients with acute bacterial skin and skin structure (including subcutaneous) infection
- It is used for confirmed/suspected infections with designated and susceptible gram-positive organisms
- There are two preparations of oritavancin
- The 400 mg dose that is administered over 3 hours, and the 1200 mg dose administered over 1 hour
Product Snapshot
- Oritavancin is an injectable, lyophilized antibiotic formulated for intravenous administration
- It is primarily used for the treatment of acute bacterial skin and skin structure infections caused by susceptible gram-positive organisms in adult patients
- Oritavancin has received regulatory approval in the United States and the European Union
Clinical Overview
Pharmacologically, oritavancin exerts bactericidal activity by targeting multiple stages of bacterial cell wall synthesis and integrity. It binds to the stem peptides of peptidoglycan precursors, inhibiting transglycosylation necessary for polymer formation. Additionally, it impedes crosslinking by interacting with pentaglycyl peptide bridging segments. Beyond cell wall inhibition, oritavancin disrupts bacterial membrane integrity, leading to cell death through multiple mechanisms. These multimodal effects contribute to its efficacy against gram-positive pathogens, including methicillin-resistant Staphylococcus aureus (MRSA).
Pharmacokinetic data indicate that oritavancin exhibits concentration-dependent killing, with a long half-life supporting single-dose administration. Two FDA-approved presentations exist: a 400 mg dose (Orbactiv) infused over three hours, and a 1200 mg dose (Kimyrsa) infused over one hour. Both are approved for the treatment of ABSSSI caused by susceptible pathogens. Oritavancin undergoes minimal metabolism and is primarily eliminated unchanged via the reticuloendothelial system. Clinicians should be aware of its interference with coagulation assays, notably artificial increases in international normalized ratio (INR) and activated partial thromboplastin time (aPTT), which may complicate monitoring in anticoagulated patients.
Safety considerations include reported infusion-related reactions and hypersensitivity events. As with all antimicrobials, susceptibility patterns vary geographically; thus, local antibiograms should guide appropriate use to ensure effective coverage. Oritavancin’s status as a cytochrome P450 inhibitor, albeit weak, suggests potential for drug interactions merits further evaluation in polypharmacy contexts.
From an API procurement perspective, oritavancin’s complex oligopeptide-based structure and lipoglycopeptide classification require stringent quality control measures to ensure batch consistency, purity, and potency. Suppliers should provide comprehensive documentation regarding synthesis processes, impurity profiles, and stability data aligned with regulatory standards to support global pharmaceutical manufacturing and formulation development.
Identification & chemistry
| Generic name | Oritavancin |
|---|---|
| Molecule type | Small molecule |
| CAS | 171099-57-3 |
| UNII | PUG62FRZ2E |
| DrugBank ID | DB04911 |
Pharmacology
| Summary | Oritavancin is a lipoglycopeptide antibiotic targeting gram-positive bacteria by inhibiting cell wall synthesis through binding peptidoglycan precursors and pentaglycyl peptide bridging segments, thereby preventing transglycosylation and crosslinking. Additionally, it disrupts bacterial cell membrane integrity, leading to cell death. Its pharmacodynamic profile includes interference with coagulation assays and potential infusion-related reactions. |
|---|---|
| Mechanism of action | The cell wall is vital for the survival and replication of bacteria, making it a primary target for antibiotic therapy. Oritavancin works against susceptible gram-positive organisms via three separate mechanisms. Firstly, it binds to the stem peptide of peptidoglycan precursors, inhibiting transglycosylation (polymerization). This process normally occurs during cell wall synthesis. Secondly, oritavancin inhibits crosslinking during bacterial cell wall biosynthesis via binding to cell wall pentaglycyl peptide bridging segments. Finally, this drug also acts by disrupting the bacterial cell membrane, interfering with its integrity, which eventually leads to cell death by various mechanisms. |
| Pharmacodynamics | Oritavancin interferes with bacterial cell wall synthesis and integrity, treating susceptible skin and subcutaneous tissue infections with gram-positive bacteria. This drug is known to artifically increase INR and aPTT, interfering with coagulation testing. Cases of infusion reactions have also been reported. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Peptidoglycan precursors | binder | |
| Bacterial cell wall peptide bridging segments | Staphylococcus aureus | inhibitor |
| Pentaglycyl bridging segment | Staphylococcus aureus | disruptor |
ADME / PK
| Absorption | Pharmacokinetic analysis of oritavancin revealed a Cmax of 138 and μg/mL and an AUC0-∞ of 2800 μg•h/mL. The AUC0-t in a study of healthy volunteers after an 800 mg dose 1,1111 μg•h/mL. was also be Another pharmacokinetic study reported a Cmax of 4.7-7.6 micrograms/mL, generally achieved within 24 hours of administration. |
|---|---|
| Half-life | The average terminal half-life of oritavancin is about 245 hours. A pharmacokinetic study revealed a terminal half-life ranging from 135.8-273.8 hours. |
| Protein binding | Oritavancin is about 85% bound to plasma proteins. |
| Metabolism | In vitro studies on human hepatocytes suggest that oritavancin is not metabolized, and is excreted unchanged. |
| Route of elimination | Oritavancin is excreted as unchanged drug in both the urine and feces. Less than 5% has been recovered in the urine, and 1% has been recovered in the feces. |
| Volume of distribution | The volume of distribution of oritavancin is estimated at 87.6 L, suggesting extensive tissue distribution. |
| Clearance | The clearance of oritavancin is approximately 0.445 L/h. One study revealed a renal clearance of 0.457 mL/min. |
Formulation & handling
- Oritavancin is a small molecule oligopeptide formulated exclusively for intravenous injection as a lyophilized powder requiring reconstitution.
- The low water solubility and peptide nature suggest careful handling to ensure complete dissolution prior to administration.
- Storage and handling should consider stability of the lyophilized powder, typically requiring protection from moisture and controlled temperature.
Regulatory status
| Lifecycle | The active pharmaceutical ingredient is protected by multiple patents in the United States extending until 2035, with earlier patents having expired since 2016. The product is marketed in both the US and EU, indicating ongoing market presence in regions with varying patent protections. |
|---|
| Markets | US, EU |
|---|
Supply Chain
| Supply chain summary | The manufacturing and supply landscape for Oritavancin includes multiple originator products with branded presence primarily in the US and EU markets. Patent data indicates several active patents extending through 2029 to 2035 in the United States, suggesting limited generic competition currently, with exclusivity periods still in effect. |
|---|
Safety
| Toxicity | The LD50 of oritavancin in rats is >500m mg/kg. Prescribing information indicates no experience with overdose during the clinical program for oritavancin, however, an overdose is likely to result in an increased risk of adverse effects, such as headache, nausea vomiting, and diarrhea. This drug is not dialyzable, and in the case of an overdose, supportive measures should be undertaken. |
|---|
- Oritavancin exhibits low acute toxicity with an LD50 in rats exceeding 500 mg/kg
- In cases of overdose, increased incidence of adverse effects such as headache, nausea, vomiting, and diarrhea may occur
- The compound is not dialyzable
Oritavancin is a type of Glycopeptides
Glycopeptides are a subcategory of pharmaceutical active pharmaceutical ingredients (APIs) that play a crucial role in the field of medicinal chemistry and drug development. These complex molecules consist of a peptide chain with one or more attached carbohydrate chains, known as glycans.
Glycopeptides possess unique chemical and structural properties that contribute to their diverse biological activities. They are primarily recognized for their potent antimicrobial properties and are commonly used to combat various bacterial infections, including methicillin-resistant Staphylococcus aureus (MRSA) and other multidrug-resistant strains. This makes them highly valuable in the pharmaceutical industry.
The glycan moieties present in glycopeptides contribute to their mode of action. These carbohydrates aid in the recognition and binding of the glycopeptides to specific bacterial targets, inhibiting cell wall synthesis and disrupting bacterial growth. This mechanism of action sets glycopeptides apart from other classes of antibiotics, making them effective against resistant bacterial strains.
Glycopeptides can be produced through synthetic or semi-synthetic methods, with natural sources such as soil bacteria serving as starting materials. Vancomycin and teicoplanin are examples of well-known glycopeptide antibiotics. Researchers continue to explore the potential of glycopeptides in areas beyond antimicrobial applications, including cancer therapy and drug delivery systems.
In summary, glycopeptides represent a vital subcategory of pharmaceutical APIs with exceptional antimicrobial properties and significant potential in various therapeutic applications. Their complex structure and unique mechanism of action make them valuable assets in the fight against drug-resistant bacteria and other diseases.
Oritavancin (Glycopeptides), classified under Antibacterials
Antibacterials, a category of pharmaceutical active pharmaceutical ingredients (APIs), play a crucial role in combating bacterial infections. These APIs are chemical compounds that target and inhibit the growth or kill bacteria, helping to eliminate harmful bacterial pathogens from the body.
Antibacterials are essential for the treatment of various bacterial infections, including respiratory tract infections, urinary tract infections, skin and soft tissue infections, and more. They are commonly prescribed by healthcare professionals to combat both mild and severe bacterial infections.
Within the category of antibacterials, there are different classes and subclasses of APIs, each with distinct mechanisms of action and target bacteria. Some commonly used antibacterials include penicillins, cephalosporins, tetracyclines, macrolides, and fluoroquinolones. These APIs work by interfering with various aspects of bacterial cellular processes, such as cell wall synthesis, protein synthesis, DNA replication, or enzyme activity.
The development and production of antibacterial APIs require stringent quality control measures to ensure their safety, efficacy, and purity. Pharmaceutical manufacturers must adhere to Good Manufacturing Practices (GMP) and follow rigorous testing protocols to guarantee the quality and consistency of these APIs.
As bacterial resistance to antibiotics continues to be a significant concern, ongoing research and development efforts aim to discover and develop new antibacterial APIs. The evolution of antibacterials plays a crucial role in combating emerging bacterial strains and ensuring effective treatment options for infectious diseases.
In summary, antibacterials are a vital category of pharmaceutical APIs used to treat bacterial infections. They are designed to inhibit or kill bacteria, and their development requires strict adherence to quality control standards. By continually advancing research in this field, scientists and pharmaceutical companies can contribute to the ongoing battle against bacterial infections.
Oritavancin API manufacturers & distributors
Compare qualified Oritavancin API suppliers worldwide. We currently have 2 companies offering Oritavancin API, with manufacturing taking place in 1 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| Apino Pharma Co., Ltd. | Producer | China | China | BSE/TSE, CoA, GMP, USDMF | 229 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CoA | 762 products |
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