Prescription medicine
Oritavancin Brand names: Kimyrsa, Orbactiv
Oritavancin (Orbactiv) is a prescription medicine with an FDA approval on record since 2014. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the oritavancin FDA label on DailyMed (effective December 18, 2025, Melinta Therapeutics, LLC); the NDA 206334 record on Drugs@FDA; every oritavancin label on DailyMed.
Highlights of the record
FDA label of December 18, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageKIMYRSA is a lipoglycopeptide antibacterial drug indicated for the treatment of adult patients with acute bacterial skin and skin structure infections caused or suspected to be caused by susceptible isolates of designated Gram-positive microorganisms.
Forms and strengths
- 400 mg
- 1200 mg/40ml
Injection (powder) (lyophilized) for solution.
On the market
- Earliest approval on file
- August 6, 2014 Orbactiv, Melinta Therap; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- July 16, 2035 Orbactiv injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 297 through July 30, 2026
What is oritavancin used for?
From the label: indications and usageKIMYRSA is a lipoglycopeptide antibacterial drug indicated for the treatment of adult patients with acute bacterial skin and skin structure infections caused or suspected to be caused by susceptible isolates of designated Gram-positive microorganisms. ( 1.1 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of KIMYRSA and other antibacterial drugs, KIMYRSA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. […]
FDA pharmacologic class: Lipoglycopeptide Antibacterial.
Source: FDA drug label (Kimyrsa), Melinta Therapeutics, LLC, effective December 18, 2025 (SPL set 5e755c40-6e73-4572-b474-4d8a131693d1), via openFDA; the full label on DailyMed
Is there a generic for oritavancin (Orbactiv)?
No generic oritavancin is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 4 patents for Orbactiv injection, the last expiring on July 16, 2035. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2014 earliest approval on file
- 2035 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the oritavancin label say about other medicines?
The oritavancin label names 2 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Heparin | contraindications | CONTRAINDICATIONS Use of intravenous unfractionated heparin sodium is contraindicated for 120 hours (5 days) after KIMYRSA administration. ( 4.1 , 5.1 ) Known hypersensitivity to oritavancin products. |
| Warfarin | drug interactions | Patients should be closely monitored for signs of toxicity or lack of efficacy if they have been given KIMYRSA while on a potentially affected compound (e.g., patients should be monitored for bleeding if concomitantly receiving KIMYRSA and warfarin). |
Source: FDA drug label (Kimyrsa), Melinta Therapeutics, LLC, effective December 18, 2025 (SPL set 5e755c40-6e73-4572-b474-4d8a131693d1), via openFDA; the full label on DailyMed
What do FAERS reports show for oritavancin?
The FDA Adverse Event Reporting System holds 297 reports that list oritavancin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 5 are coded as a death and 30 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Alternatives to oritavancin
- medicines labeled for the same conditions
- Other lipoglycopeptide antibacterials
- the pharmacologic class, with prices and generics
- Oritavancin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other