cabotegravir; rilpivirine · Viiv Hlthcare · NDA 212888
Cabenuva Kit
Earliest generic entry, as listed · earliest of 2 marketed strengths
1 Oct 2040
Blocked by patent: US 12636285, US 12636286. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 9 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 12636285 | use U-3348 · sets the listed date | 1 Oct 2040 |
| US 12636286 | use U-3348 · sets the listed date | 1 Oct 2040 |
| US 12178815 | use U-3348 | 18 Jul 2038 |
| US 11389448 | drug product | 13 Apr 2032 |
| US RE50189 | use U-3348 | 27 Nov 2031 |
| US 11224597 | drug product, use U-3348 | 15 Sep 2031 |
| US 12138264 | drug product, use U-3348 | 15 Sep 2031 |
| US 8410103 | drug substance, drug product, use U-3348 | 4 Feb 2031 |
| US 11389447 | use U-3405 | 30 Jun 2027 |
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 212888 · 001 · RLD | suspension, extended release, intramuscular | 400MG/2ML (200MG/ML);600MG/2ML (300MG/ML) | 1 Oct 2040 |
| 212888 · 002 · RLD | suspension, extended release, intramuscular | 600MG/3ML (200MG/ML);900MG/3ML (300MG/ML) | 1 Oct 2040 |
Expired or delisted (2)
- US 10927129 · substance, product · 28 Apr 2026
- NCE · 21 Jan 2026