Orange Book product · Brand (NDA)
BIKTARVY
BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
At a glance
Oct 07, 2021
Approved
Brand (NDA)
Application
Not listed
TE code
9
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 07, 2021
4 yr 9 mo ago
Today
Exclusivity ends · I-942
New indication exclusivity (3 years)
Feb 23, 2027
in 8 mo
Exclusivity ends · ODE-378
Orphan-drug exclusivity (7 years)
Oct 07, 2028
in 2 yr 4 mo
Exclusivity ends · ODE-468
Orphan-drug exclusivity (7 years)
Feb 23, 2031
in 4 yr 9 mo
Exclusivity ends · ODE-540
Orphan-drug exclusivity (7 years)
Jul 30, 2032
in 6 yr 2 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
Patent 9216996 expires
Listed drug substance patent expiration.
Dec 19, 2033
in 7 yr 7 mo
Patent 9732092 expires
Listed drug substance patent expiration.
Dec 19, 2033
in 7 yr 7 mo
Patent 10385067 expires
Listed method-of-use patent (U-257) expiration.
Jun 19, 2035
in 9 yr 2 mo
Patent 9708342 expires
Listed drug substance patent expiration.
Jun 19, 2035
in 9 yr 2 mo
Patent 12594244 expires
Listed drug product patent expiration.
Nov 08, 2036
in 10 yr 7 mo
Pharmaceutical detail
Active ingredient
BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
Strength
EQ 30MG BASE;120MG;EQ 15MG BASE
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 210251
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 (4)
- I-942New indication exclusivity (3 years)
Feb 23, 2027
in 8 mo
- ODE-378Orphan-drug exclusivity (7 years)
Oct 07, 2028
in 2 yr 4 mo
- ODE-468Orphan-drug exclusivity (7 years)
Feb 23, 2031
in 4 yr 9 mo
- ODE-540Orphan-drug exclusivity (7 years)
Jul 30, 2032
in 6 yr 2 mo
Listed patents (9)
| 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 | |
| 9216996 | Dec 19, 2033 | in 7 yr 7 mo | SubstanceProduct |
| 9732092 | Dec 19, 2033 | in 7 yr 7 mo | SubstanceProduct |
| 10385067 | Jun 19, 2035 | in 9 yr 2 mo | U-257 |
| 9708342 | Jun 19, 2035 | in 9 yr 2 mo | SubstanceProduct |
| 12594244 | Nov 08, 2036 | in 10 yr 7 mo | ProductU-257 |
