Orange Book product · Brand (NDA)
PREVYMIS
LETERMOVIR
At a glance
Nov 08, 2017
Approved
Brand (NDA)
Application
Not listed
TE code
1
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 08, 2017
8 yr 9 mo ago
Exclusivity ends · I-916
New indication exclusivity (3 years)
Jun 05, 2026
14 d ago
Today
Exclusivity ends · D-189
New indication / change exclusivity (3 years)
Aug 02, 2026
in 1 mo
Exclusivity ends · NPP
New patient population 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-423
Orphan-drug exclusivity (7 years)
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
240MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 209939
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 (6)
- I-916New indication exclusivity (3 years)
Jun 05, 2026
14 d ago
- D-189New indication / change exclusivity (3 years)
Aug 02, 2026
in 1 mo
- NPPNew patient population exclusivity (3 years)
Aug 30, 2027
in 1 yr 3 mo
- ODE-423Orphan-drug exclusivity (7 years)
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 |
