Orange Book product · Brand (NDA)
LIVTENCITY
MARIBAVIR
At a glance
Nov 23, 2021
Approved
Brand (NDA)
Application
Not listed
TE code
7
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 23, 2021
4 yr 8 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Nov 23, 2026
in 5 mo
Exclusivity ends · ODE-388
Orphan-drug exclusivity (7 years)
Nov 23, 2028
in 2 yr 6 mo
Patent 12447169 expires
Listed method-of-use patent (U-4329) expiration.
Oct 27, 2031
in 5 yr 5 mo
Patent 11684632 expires
Listed method-of-use patent (U-3650) expiration.
Jan 04, 2032
in 5 yr 8 mo
Patent 12213989 expires
Listed method-of-use patent (U-4137) expiration.
Nov 18, 2042
in 16 yr 8 mo
Patent 12433907 expires
Listed method-of-use patent (U-4289) expiration.
Nov 18, 2042
in 16 yr 8 mo
Patent 12447170 expires
Listed method-of-use patent (U-4328) expiration.
Nov 18, 2042
in 16 yr 8 mo
Patent 12295940 expires
Listed drug substance patent expiration.
Oct 11, 2043
in 17 yr 7 mo
Patent 12527771 expires
Listed drug substance patent expiration.
Oct 11, 2043
in 17 yr 7 mo
Pharmaceutical detail
Active ingredient
MARIBAVIR
Strength
200MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 215596
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)
Nov 23, 2026
in 5 mo
- ODE-388Orphan-drug exclusivity (7 years)
Nov 23, 2028
in 2 yr 6 mo
Listed patents (7)
| Patent | Expires | In | Type |
|---|---|---|---|
| 12447169 | Oct 27, 2031 | in 5 yr 5 mo | U-4329 |
| 11684632 | Jan 04, 2032 | in 5 yr 8 mo | U-3650 |
| 12213989 | Nov 18, 2042 | in 16 yr 8 mo | U-4137 |
| 12433907 | Nov 18, 2042 | in 16 yr 8 mo | U-4289 |
| 12447170 | Nov 18, 2042 | in 16 yr 8 mo | U-4328 |
| 12295940 | Oct 11, 2043 | in 17 yr 7 mo | SubstanceProduct |
| 12527771 | Oct 11, 2043 | in 17 yr 7 mo | SubstanceProduct |

