Orange Book product · Brand (NDA)
VEMLIDY
TENOFOVIR ALAFENAMIDE FUMARATE
At a glance
Nov 10, 2016
Approved
Brand (NDA)
Application
AB
TE code
8
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 10, 2016
9 yr 9 mo ago
Today
Exclusivity ends · NPP
New patient population exclusivity (3 years)
Mar 27, 2027
in 9 mo
Patent 8754065 expires
Listed drug substance patent expiration.
Aug 15, 2032
in 6 yr 3 mo
Patent 8754065 expires
Listed drug substance patent expiration.
Aug 15, 2032
in 6 yr 3 mo
Patent 8754065 expires
Listed drug substance patent expiration.
Aug 15, 2032
in 6 yr 3 mo
Patent 9296769 expires
Listed drug substance patent expiration.
Aug 15, 2032
in 6 yr 3 mo
Patent 9296769 expires
Listed drug substance patent expiration.
Aug 15, 2032
in 6 yr 3 mo
Patent 9296769 expires
Listed drug substance patent expiration.
Aug 15, 2032
in 6 yr 3 mo
Patent 8754065*PED expires
Listed listed patent expiration.
Feb 15, 2033
in 6 yr 9 mo
Patent 9296769*PED expires
Listed listed patent expiration.
Feb 15, 2033
in 6 yr 9 mo
Pharmaceutical detail
Active ingredient
TENOFOVIR ALAFENAMIDE FUMARATE
Strength
EQ 25MG BASE
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 208464
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 (1)
- NPPNew patient population exclusivity (3 years)
Mar 27, 2027
in 9 mo
Listed patents (8)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8754065 | Aug 15, 2032 | in 6 yr 3 mo | SubstanceProductU-999 |
| 8754065 | Aug 15, 2032 | in 6 yr 3 mo | SubstanceProductU-1275 |
| 8754065 | Aug 15, 2032 | in 6 yr 3 mo | SubstanceProductU-3880 |
| 9296769 | Aug 15, 2032 | in 6 yr 3 mo | SubstanceProductU-1275 |
| 9296769 | Aug 15, 2032 | in 6 yr 3 mo | SubstanceProductU-3880 |
| 9296769 | Aug 15, 2032 | in 6 yr 3 mo | SubstanceProductU-999 |
| 8754065*PED | Feb 15, 2033 | in 6 yr 9 mo | |
| 9296769*PED | Feb 15, 2033 | in 6 yr 9 mo |
