Orange Book product · Brand (NDA)
CABENUVA KIT
CABOTEGRAVIR; RILPIVIRINE
At a glance
Jan 21, 2021
Approved
Brand (NDA)
Application
Not listed
TE code
10
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 21, 2021
5 yr 6 mo ago
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Jan 21, 2026
5 mo ago
Patent 10927129 expires
Listed drug substance patent expiration.
Apr 28, 2026
2 mo ago
Today
Patent 11389447 expires
Listed method-of-use patent (U-3405) expiration.
Jun 30, 2027
in 1 yr 1 mo
Patent 8410103 expires
Listed drug substance patent expiration.
Feb 04, 2031
in 4 yr 8 mo
Patent 11224597 expires
Listed drug product patent expiration.
Sep 15, 2031
in 5 yr 4 mo
Patent 12138264 expires
Listed drug product patent expiration.
Sep 15, 2031
in 5 yr 4 mo
Patent RE50189 expires
Listed method-of-use patent (U-3348) expiration.
Nov 27, 2031
in 5 yr 6 mo
Patent 11389448 expires
Listed drug product patent expiration.
Apr 13, 2032
in 5 yr 11 mo
Patent 12178815 expires
Listed method-of-use patent (U-3348) expiration.
Jul 18, 2038
in 12 yr 3 mo
Patent 12636285 expires
Listed method-of-use patent (U-3348) expiration.
Oct 01, 2040
in 14 yr 6 mo
Patent 12636286 expires
Listed method-of-use patent (U-3348) expiration.
Oct 01, 2040
in 14 yr 6 mo
Pharmaceutical detail
Active ingredient
CABOTEGRAVIR; RILPIVIRINE
Strength
400MG/2ML (200MG/ML);600MG/2ML (300MG/ML)
Dosage form
SUSPENSION, EXTENDED RELEASE
Route
INTRAMUSCULAR
TE code
Not listed
Application
NDA 212888
Product number
001
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 (1)
- NCENew chemical entity exclusivity (5 years)
Jan 21, 2026
5 mo ago
Listed patents (10)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10927129 | Apr 28, 2026 | 2 mo ago | SubstanceProduct |
| 11389447 | Jun 30, 2027 | in 1 yr 1 mo | U-3405 |
| 8410103 | Feb 04, 2031 | in 4 yr 8 mo | SubstanceProductU-3348 |
| 11224597 | Sep 15, 2031 | in 5 yr 4 mo | ProductU-3348 |
| 12138264 | Sep 15, 2031 | in 5 yr 4 mo | ProductU-3348 |
| RE50189 | Nov 27, 2031 | in 5 yr 6 mo | U-3348 |
| 11389448 | Apr 13, 2032 | in 5 yr 11 mo | Product |
| 12178815 | Jul 18, 2038 | in 12 yr 3 mo | U-3348 |
| 12636285 | Oct 01, 2040 | in 14 yr 6 mo | U-3348 |
| 12636286 | Oct 01, 2040 | in 14 yr 6 mo | U-3348 |

