Orange Book product · Brand (NDA)
VOCABRIA
CABOTEGRAVIR SODIUM
At a glance
Jan 21, 2021
Approved
Brand (NDA)
Application
Not listed
TE code
2
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 8410103 expires
Listed drug substance patent expiration.
Feb 04, 2031
in 4 yr 8 mo
Pharmaceutical detail
Active ingredient
CABOTEGRAVIR SODIUM
Strength
EQ 30MG BASE
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 212887
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.
Marketing exclusivity (1)
- NCENew chemical entity exclusivity (5 years)
Jan 21, 2026
5 mo ago
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10927129 | Apr 28, 2026 | 2 mo ago | SubstanceProduct |
| 8410103 | Feb 04, 2031 | in 4 yr 8 mo | SubstanceProductU-3348 |
