FDA Orange Book
Is there a generic for Xenleta?
Xenleta contains lefamulin acetate. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Xenleta (lefamulin acetate). The Orange Book shows its last listed patent expires June 14, 2036 and its last listed exclusivity ends August 19, 2029.
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Xenleta products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, intravenous | EQ 150MG BASE/15ML (EQ 10MG BASE/ML) | Marketed (Rx) | None | 0 | None |
| tablet, oral | EQ 600MG BASE | Marketed (Rx) | None | 0 | None |
NDA 211673, 211672, held by HONG KONG KING FRIEND INDUSTRIAL CO LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Xenleta patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8153689 | March 19, 2028 | Drug substance, Drug product | None | 211673 |
| 9120727 | May 23, 2031 | Drug substance, Drug product | None | 211672 |
| 8071643 | March 25, 2033 | Drug substance, Drug product | None | 211673 |
| 12121582 | June 14, 2036 | Drug product | None | 211673 |
Xenleta exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | August 19, 2024 | 211673 |
| GAIN | Generating Antibiotic Incentives Now | August 19, 2029 | 211673 |
Xenleta NDC codes
Questions
Is there a generic for Xenleta?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Xenleta (lefamulin acetate). The Orange Book shows its last listed patent expires June 14, 2036 and its last listed exclusivity ends August 19, 2029.
What is the generic name for Xenleta?
The active ingredient in Xenleta is lefamulin acetate, per the FDA Orange Book.
When does the Xenleta patent expire?
The last patent listed for Xenleta in the Orange Book expires June 14, 2036. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.