Orange Book product · Brand (NDA)
SYMTUZA
COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
At a glance
Jul 17, 2018
Approved
Brand (NDA)
Application
Not listed
TE code
13
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 17, 2018
8 yr ago
Today
Patent 7700645 expires
Listed drug substance patent expiration.
Dec 26, 2026
in 6 mo
Patent 8148374 expires
Listed drug substance patent expiration.
Sep 03, 2029
in 3 yr 3 mo
Patent 8148374 expires
Listed drug substance patent expiration.
Sep 03, 2029
in 3 yr 3 mo
Patent 8148374 expires
Listed drug substance patent expiration.
Sep 03, 2029
in 3 yr 3 mo
Patent 8148374 expires
Listed drug substance patent expiration.
Sep 03, 2029
in 3 yr 3 mo
Patent 8148374 expires
Listed drug substance patent expiration.
Sep 03, 2029
in 3 yr 3 mo
Patent 8148374 expires
Listed drug substance patent expiration.
Sep 03, 2029
in 3 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 10039718 expires
Listed drug product patent expiration.
Oct 06, 2032
in 6 yr 5 mo
Patent 10786518 expires
Listed method-of-use patent (U-2978) expiration.
Jul 19, 2038
in 12 yr 3 mo
Pharmaceutical detail
Active ingredient
COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
Strength
150MG;800MG;200MG;EQ 10MG BASE
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 210455
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 (13)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7700645 | Dec 26, 2026 | in 6 mo | SubstanceProduct |
| 8148374 | Sep 03, 2029 | in 3 yr 3 mo | SubstanceProductU-2353 |
| 8148374 | Sep 03, 2029 | in 3 yr 3 mo | SubstanceProductU-2767 |
| 8148374 | Sep 03, 2029 | in 3 yr 3 mo | SubstanceProductU-2768 |
| 8148374 | Sep 03, 2029 | in 3 yr 3 mo | SubstanceProductU-2766 |
| 8148374 | Sep 03, 2029 | in 3 yr 3 mo | SubstanceProductU-2364 |
| 8148374 | Sep 03, 2029 | in 3 yr 3 mo | SubstanceProductU-2365 |
| 8754065 | Aug 15, 2032 | in 6 yr 3 mo | SubstanceProductU-2352 |
| 8754065 | Aug 15, 2032 | in 6 yr 3 mo | SubstanceProductU-2765 |
| 9296769 | Aug 15, 2032 | in 6 yr 3 mo | SubstanceProductU-2352 |
| 9296769 | Aug 15, 2032 | in 6 yr 3 mo | SubstanceProductU-2765 |
| 10039718 | Oct 06, 2032 | in 6 yr 5 mo | Product |
| 10786518 | Jul 19, 2038 | in 12 yr 3 mo | U-2978 |
