FDA Orange Book
Is there a generic for Apretude?
Apretude contains cabotegravir. 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 Apretude (cabotegravir). The Orange Book shows its last listed patent expires September 15, 2031 and its last listed exclusivity ends January 21, 2026.
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Apretude products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| suspension, extended release, intramuscular | 600MG/3ML (200MG/ML) | Marketed (Rx) | None | 0 | None |
NDA 215499, 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.
Apretude patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10927129 | April 28, 2026 | Drug substance, Drug product | None | 215499 |
| 8410103 | February 4, 2031 | Drug substance, Drug product | None | 215499 |
| 12138264 | September 15, 2031 | Drug product | None | 215499 |
| 11224597 | September 15, 2031 | Drug product | None | 215499 |
Apretude exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | January 21, 2026 | 215499 |
Questions
Is there a generic for Apretude?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Apretude (cabotegravir). The Orange Book shows its last listed patent expires September 15, 2031 and its last listed exclusivity ends January 21, 2026.
What is the generic name for Apretude?
The active ingredient in Apretude is cabotegravir, per the FDA Orange Book.
When does the Apretude patent expire?
The last patent listed for Apretude in the Orange Book expires September 15, 2031. 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.