Orange Book product · Brand (NDA)
GENVOYA
COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
At a glance
Nov 05, 2015
Approved
Brand (NDA)
Application
Not listed
TE code
18
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 05, 2015
10 yr 9 mo ago
Today
Patent 7176220 expires
Listed drug substance patent expiration.
Aug 27, 2026
in 2 mo
Patent 7635704 expires
Listed drug substance patent expiration.
Oct 26, 2026
in 4 mo
Patent 8981103 expires
Listed drug substance patent expiration.
Oct 26, 2026
in 4 mo
Patent 7176220*PED expires
Listed listed patent expiration.
Feb 27, 2027
in 8 mo
Patent 7635704*PED expires
Listed listed patent expiration.
Apr 26, 2027
in 10 mo
Patent 8981103*PED expires
Listed listed patent expiration.
Apr 26, 2027
in 10 mo
Patent 8148374 expires
Listed drug substance patent expiration.
Sep 03, 2029
in 3 yr 3 mo
Patent 9891239 expires
Listed drug product patent expiration.
Sep 03, 2029
in 3 yr 3 mo
Patent 8148374*PED expires
Listed listed patent expiration.
Mar 03, 2030
in 3 yr 9 mo
Patent 9891239*PED expires
Listed listed patent expiration.
Mar 03, 2030
in 3 yr 9 mo
Patent 8633219 expires
Listed drug product patent expiration.
Apr 30, 2030
in 3 yr 11 mo
Patent 8633219*PED expires
Listed listed patent expiration.
Oct 30, 2030
in 4 yr 5 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 10039718 expires
Listed drug product patent expiration.
Oct 06, 2032
in 6 yr 5 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
Patent 10039718*PED expires
Listed listed patent expiration.
Apr 06, 2033
in 6 yr 11 mo
Pharmaceutical detail
Active ingredient
COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
Strength
150MG;150MG;200MG;EQ 10MG BASE
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 207561
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 (18)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7176220 | Aug 27, 2026 | in 2 mo | SubstanceProductU-257 |
| 7635704 | Oct 26, 2026 | in 4 mo | SubstanceProductU-257 |
| 8981103 | Oct 26, 2026 | in 4 mo | SubstanceProduct |
| 7176220*PED | Feb 27, 2027 | in 8 mo | |
| 7635704*PED | Apr 26, 2027 | in 10 mo | |
| 8981103*PED | Apr 26, 2027 | in 10 mo | |
| 8148374 | Sep 03, 2029 | in 3 yr 3 mo | SubstanceProductU-1279 |
| 9891239 | Sep 03, 2029 | in 3 yr 3 mo | ProductU-257 |
| 8148374*PED | Mar 03, 2030 | in 3 yr 9 mo | |
| 9891239*PED | Mar 03, 2030 | in 3 yr 9 mo | |
| 8633219 | Apr 30, 2030 | in 3 yr 11 mo | ProductU-257 |
| 8633219*PED | Oct 30, 2030 | in 4 yr 5 mo | |
| 8754065 | Aug 15, 2032 | in 6 yr 3 mo | SubstanceProductU-257 |
| 9296769 | Aug 15, 2032 | in 6 yr 3 mo | SubstanceProductU-257 |
| 10039718 | Oct 06, 2032 | in 6 yr 5 mo | Product |
| 8754065*PED | Feb 15, 2033 | in 6 yr 9 mo | |
| 9296769*PED | Feb 15, 2033 | in 6 yr 9 mo | |
| 10039718*PED | Apr 06, 2033 | in 6 yr 11 mo |
