Orange Book product · Brand (NDA)
DESCOVY
EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
At a glance
Jan 07, 2022
Approved
Brand (NDA)
Application
Not listed
TE code
4
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 07, 2022
4 yr 6 mo ago
Today
Exclusivity ends · M-316
New use / labeling-change exclusivity (3 years)
Jun 20, 2028
in 2 yr
Exclusivity ends · ODE-457
Orphan-drug exclusivity (7 years)
Jan 07, 2029
in 2 yr 7 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 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; TENOFOVIR ALAFENAMIDE FUMARATE
Strength
120MG;EQ 15MG BASE
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 208215
Product number
002
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 (2)
- M-316New use / labeling-change exclusivity (3 years)
Jun 20, 2028
in 2 yr
- ODE-457Orphan-drug exclusivity (7 years)
Jan 07, 2029
in 2 yr 7 mo
Listed patents (4)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8754065 | Aug 15, 2032 | in 6 yr 3 mo | SubstanceProductU-1663 |
| 9296769 | Aug 15, 2032 | in 6 yr 3 mo | SubstanceProductU-1663 |
| 8754065*PED | Feb 15, 2033 | in 6 yr 9 mo | |
| 9296769*PED | Feb 15, 2033 | in 6 yr 9 mo |
