FDA Orange Book · active-ingredient family
Cabotegravir; rilpivirine
Cabotegravir; rilpivirine is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:CABENUVA KIT · NDA 212888
1
Brand (NDA)
0
Generics (ANDA)
10
Listed patents
2
Exclusivity periods
Brand (NDA) products · suspension, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CABENUVA KITRLD×2 | VIIV HLTHCARE | NDA 212888 | — | Jan 21, 2021 |
Marketing exclusivity (2)
- NCENew chemical entity exclusivity (5 years)
Jan 21, 2026
5 mo ago
- 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 |
| 12138264 | Sep 15, 2031 | in 5 yr 4 mo | ProductU-3348 |
| 11224597 | 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 |
| 12636286 | Oct 01, 2040 | in 14 yr 6 mo | U-3348 |
| 12636285 | Oct 01, 2040 | in 14 yr 6 mo | U-3348 |
Cabotegravir; rilpivirine — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
