Orange Book product · Brand (NDA)
PREVYMIS
LETERMOVIR
At a glance
Aug 30, 2024
Approved
Brand (NDA)
Application
Not listed
TE code
1
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 30, 2024
1 yr 10 mo ago
Today
Exclusivity ends · NP
New product exclusivity (3 years)
Aug 30, 2027
in 1 yr 3 mo
Patent RE46791 expires
Listed drug substance patent expiration.
Jan 18, 2029
in 2 yr 7 mo
Exclusivity ends · ODE*
FDA marketing exclusivity
Jun 05, 2030
in 4 yr
Exclusivity ends · ODE-495
Orphan-drug exclusivity (7 years)
Aug 30, 2031
in 5 yr 3 mo
Exclusivity ends · ODE-497
Orphan-drug exclusivity (7 years)
Aug 30, 2031
in 5 yr 3 mo
Pharmaceutical detail
Active ingredient
LETERMOVIR
Strength
20MG/PACKET
Dosage form
PELLETS
Route
ORAL
TE code
Not listed
Application
NDA 219104
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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 (4)
- NPNew product exclusivity (3 years)
Aug 30, 2027
in 1 yr 3 mo
- ODE*FDA marketing exclusivity
Jun 05, 2030
in 4 yr
- ODE-495Orphan-drug exclusivity (7 years)
Aug 30, 2031
in 5 yr 3 mo
- ODE-497Orphan-drug exclusivity (7 years)
Aug 30, 2031
in 5 yr 3 mo
Listed patents (1)
| Patent | Expires | In | Type |
|---|---|---|---|
| RE46791 | Jan 18, 2029 | in 2 yr 7 mo | SubstanceProduct |
