Orange Book product · Brand (NDA)
ODEFSEY
EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR ALAFENAMIDE FUMARATE
At a glance
Mar 01, 2016
Approved
Brand (NDA)
Application
AB
TE code
4
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 01, 2016
10 yr 5 mo ago
Today
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 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
EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR ALAFENAMIDE FUMARATE
Strength
200MG;EQ 25MG BASE;EQ 25MG BASE
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 208351
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.
Listed patents (4)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8754065 | Aug 15, 2032 | in 6 yr 3 mo | SubstanceProductU-257 |
| 9296769 | Aug 15, 2032 | in 6 yr 3 mo | SubstanceProductU-257 |
| 8754065*PED | Feb 15, 2033 | in 6 yr 9 mo | |
| 9296769*PED | Feb 15, 2033 | in 6 yr 9 mo |
