cabotegravir · Viiv Hlthcare · NDA 215499
Apretude
Earliest generic entry, as listed
15 Sep 2031
Blocked by patent: US 11224597, US 12138264.
Listed patents · 3 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11224597 | product | 15 Sep 2031 |
| US 12138264 | product | 15 Sep 2031 |
| US 8410103 | substance, product | 4 Feb 2031 |
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 · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 215499 · 001 · RLD | suspension, extended release, intramuscular | 600MG/3ML (200MG/ML) | 15 Sep 2031 |
Expired or delisted (2)
- US 10927129 · substance, product · 28 Apr 2026
- NCE · 21 Jan 2026