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 8071643 expires
Listed drug substance patent expiration.
Mar 25, 2033
in 6 yr 10 mo
Patent 12121582 expires
Listed drug product patent expiration.
Jun 14, 2036
in 10 yr 2 mo
Pharmaceutical detail
Active ingredient
LEFAMULIN ACETATE
Strength
EQ 150MG BASE/15ML (EQ 10MG BASE/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 211673
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 |
| 8071643 | Mar 25, 2033 | in 6 yr 10 mo | SubstanceProduct |
| 12121582 | Jun 14, 2036 | in 10 yr 2 mo | Product |
