Prescription medicine
Lefamulin Brand names: Xenleta
Lefamulin (Xenleta) is a prescription medicine with an FDA approval on record since 2019. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: lefamulin labels on DailyMed; the NDA 211672 record on Drugs@FDA; every lefamulin label on DailyMed.
Highlights of the record
no current FDA label; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
The label in openFDA carries no indications section.
Forms and strengths
- 600 mg
- 150 mg/15ml
Coated tablet; injection (solution).
On the market
- Earliest approval on file
- August 19, 2019 Xenleta, Hong Kong; Drugs@FDA’s file, where older or withdrawn approvals can be missing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
- June 14, 2036 Xenleta 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
- 17 through July 30, 2026
Is there a generic for lefamulin (Xenleta)?
No generic lefamulin is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 3 patents for Xenleta injection: the compound patent runs to March 25, 2033, and the last listed entry to June 14, 2036. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2019 earliest approval on file
- 2036 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for lefamulin?
The FDA Adverse Event Reporting System holds 17 reports that list lefamulin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1 are coded as a death and 1 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?
- Other anti-coagulants
- the pharmacologic class, with prices and generics
- Lefamulin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other