Orange Book product · Brand (NDA)
XENLETA
LEFAMULIN ACETATE
At a glance
Aug 19, 2019
Approved
Brand (NDA)
Application
Not listed
TE code
3
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 19, 2019
6 yr 11 mo ago
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Aug 19, 2024
1 yr 10 mo ago
Today
Patent 8153689 expires
Listed drug substance patent expiration.
Mar 19, 2028
in 1 yr 9 mo
Exclusivity ends · GAIN
Qualified infectious disease product exclusivity (adds 5 years)
Aug 19, 2029
in 3 yr 3 mo
Patent 9120727 expires
Listed drug substance patent expiration.
May 23, 2031
in 5 yr
Patent 8071643 expires
Listed drug substance patent expiration.
Mar 25, 2033
in 6 yr 10 mo
Pharmaceutical detail
Active ingredient
LEFAMULIN ACETATE
Strength
EQ 600MG BASE
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 211672
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Marketing exclusivity (2)
- NCENew chemical entity exclusivity (5 years)
Aug 19, 2024
1 yr 10 mo ago
- GAINQualified infectious disease product exclusivity (adds 5 years)
Aug 19, 2029
in 3 yr 3 mo
Listed patents (3)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8153689 | Mar 19, 2028 | in 1 yr 9 mo | SubstanceProduct |
| 9120727 | May 23, 2031 | in 5 yr | SubstanceProduct |
| 8071643 | Mar 25, 2033 | in 6 yr 10 mo | SubstanceProduct |
