FDA Orange Book
Is there a generic for Cabenuva Kit?
Cabenuva Kit contains cabotegravir and rilpivirine. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Cabenuva Kit (cabotegravir and rilpivirine). The Orange Book shows its last listed patent expires October 1, 2040 and its last listed exclusivity ends January 21, 2026.
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Cabenuva Kit products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| suspension, extended release, intramuscular | 400MG/2ML (200MG/ML);600MG/2ML (300MG/ML) | Marketed (Rx) | None | 0 | None |
| suspension, extended release, intramuscular | 600MG/3ML (200MG/ML);900MG/3ML (300MG/ML) | Marketed (Rx) | None | 0 | None |
NDA 212888, held by VIIV HEALTHCARE CO. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Cabenuva Kit patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10927129 | April 28, 2026 | Drug substance, Drug product | None | 212888 |
| 11389447 | June 30, 2027 | Method of use | U-3405 | 212888 |
| 8410103 | February 4, 2031 | Drug substance, Drug product | U-3348 | 212888 |
| 12138264 | September 15, 2031 | Drug product | U-3348 | 212888 |
| 11224597 | September 15, 2031 | Drug product | U-3348 | 212888 |
| RE50189 | November 27, 2031 | Method of use | U-3348 | 212888 |
| 11389448 | April 13, 2032 | Drug product | None | 212888 |
| 12178815 | July 18, 2038 | Method of use | U-3348 | 212888 |
| 12636286 | October 1, 2040 | Method of use | U-3348 | 212888 |
| 12636285 | October 1, 2040 | Method of use | U-3348 | 212888 |
Cabenuva Kit exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | January 21, 2026 | 212888 |
Questions
Is there a generic for Cabenuva Kit?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Cabenuva Kit (cabotegravir and rilpivirine). The Orange Book shows its last listed patent expires October 1, 2040 and its last listed exclusivity ends January 21, 2026.
What is the generic name for Cabenuva Kit?
The active ingredient in Cabenuva Kit is cabotegravir and rilpivirine, per the FDA Orange Book.
When does the Cabenuva Kit patent expire?
The last patent listed for Cabenuva Kit in the Orange Book expires October 1, 2040. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.