acetaminophen; ibuprofen sodium · Hikma · NDA 215320
Combogesic Iv
Earliest generic entry, as listed
14 Jan 2036
Blocked by patent: US 11213498.
Listed patents · 6 unexpired
10 Orange Book listing rows for 6 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 11213498 | drug product · sets the listed date | 14 Jan 2036 |
| US 11389416 | drug product | 17 Jul 2035 |
| US 12083087 | use U-3744, U-3745 | 17 Jul 2035 |
| US 12083087 listing row | use U-3744 | 17 Jul 2035 |
| US 12083087 listing row | use U-3745 | 17 Jul 2035 |
| US 11446266 | use U-3744, U-3745 | 26 Oct 2031 |
| US 11446266 listing row | use U-3744 | 26 Oct 2031 |
| US 11446266 listing row | use U-3745 | 26 Oct 2031 |
| US 11896567 | use U-3744, U-3745 | 26 Oct 2031 |
| US 11896567 listing row | use U-3744 | 26 Oct 2031 |
| US 11896567 listing row | use U-3745 | 26 Oct 2031 |
| US 12220392 | use U-4306, U-4307 | 26 Oct 2031 |
| US 12220392 listing row | use U-4306 | 26 Oct 2031 |
| US 12220392 listing row | use U-4307 | 26 Oct 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 |
|---|---|---|---|
| 215320 · 001 · RLD | solution, intravenous | 1GM/100ML (10MG/ML);EQ 300MG BASE/100ML (EQ 3MG BASE/ML) | 14 Jan 2036 |
Expired or delisted (1)
- NP · 17 Oct 2026