ORBACTIV (oritavancin diphosphate)
Orbactiv treats adults with acute bacterial skin and skin structure infections. It helps patients fighting infections caused by Gram-positive microorganisms, including methicillin-resistant Staphylococcus aureus (MRSA) and certain Streptococcus and Enterococcus species. Healthcare providers use this medication to resolve proven or strongly suspected bacterial infections while helping to minimize the rise of drug-resistant bacteria.
How ORBACTIV Works
This medication works as a lipoglycopeptide antibacterial to combat specific Gram-positive bacteria. It targets susceptible isolates to clear infections in the skin and underlying skin structures.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2014-08-06
- Patent Cliff
- 2035
- Routes
- INTRAVENOUS
- Dosage Forms
- POWDER
ORBACTIV Approval History
What ORBACTIV Treats
1 indicationsORBACTIV is approved for 1 conditions since its original approval in 2014. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Bacterial Skin and Skin Structure Infections
ORBACTIV Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Clinical Trial Registry
9 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07550595 OSCAR | OSCAR | Ph 2 | not yet recruiting | Oritavancin for Treatment of Serious Cardiac Infections |
| NCT02134301 | TMC-ORI-11-01 2013-005415-26 | Ph 1 | completed | Open Label, Dose-finding, Pharmacokinetics, Safety and Tolerability Study of Oritavancin in Pediatric Participants With Suspected or Confirmed Bacterial Infections |
| NCT05599295 | ML-ORI-201 2024-516385-10-00 | Ph 2 | completed | Study to Evaluate the Safety of Intravenous Oritavancin for the Treatment of Children With Skin Infections |
| NCT05521880 AIM-STOP | HP-00101580 | Ph 4 | terminated | Anchoring Sequential Intermittent Long Acting Antimicrobials With Medication for Opioid Use Disorder (MOUD) for Invasive Infections Related to Opioid Use |
| NCT02925416 results posted | MDCO-ORI-16-02 | Ph 4 | completed | Safety of Either a Single or Two Intravenous Doses of Orbactiv in Participants With Acute Bacterial Skin and Skin Structure Infection |
| NCT02452918 results posted | MDCO-ORI-14-03 | Ph 4 | completed | A Study to Evaluate the Safety of a Single Intravenous (IV) Dose of Orbactiv (Oritavancin) in Participants on Chronic Warfarin Therapy Being Treated For Acute Bacterial Skin and Skin Structure Infection (ABSSSI) |
| NCT02471690 | MDCO-ORI-15-01 | Ph 1 | completed | Study to Evaluate the Safety, Tolerability and Pharmacokinetics of a New Formulation of Oritavancin in Healthy Volunteers |
| NCT02470702 | MDCO-ORI-15-02 | Ph 1 | completed | Multiple Oritavancin Doses on Safety, Tolerability, and Pharmacokinetics in Healthy Subjects |
| NCT02357524 | MDCO-ORI-14-01 | Ph 1 | completed | Oritavancin on the Results of Multiple Coagulation Tests in Healthy Volunteers |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ORBACTIV FDA Label Details
Indications & Usage
FDA Label (PDF)ORBACTIV is indicated for the treatment of Bacterial Skin and Skin Structure Infections.
ORBACTIV Patents & Exclusivity
Patents (4 active)
Pro Intelligence Preview
Deep insights for ORBACTIV
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2035
- • 4 active patents
Trial Analysis
- • 10 total trials
- • Stage: Stable
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment