Orange Book product · Brand (NDA)
COMBOGESIC IV
ACETAMINOPHEN; IBUPROFEN SODIUM
At a glance
Oct 17, 2023
Approved
Brand (NDA)
Application
Not listed
TE code
10
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 17, 2023
2 yr 9 mo ago
Today
Exclusivity ends · NP
New product exclusivity (3 years)
Oct 17, 2026
in 4 mo
Patent 11446266 expires
Listed method-of-use patent (U-3744) expiration.
Oct 26, 2031
in 5 yr 5 mo
Patent 11446266 expires
Listed method-of-use patent (U-3745) expiration.
Oct 26, 2031
in 5 yr 5 mo
Patent 11896567 expires
Listed method-of-use patent (U-3744) expiration.
Oct 26, 2031
in 5 yr 5 mo
Patent 11896567 expires
Listed method-of-use patent (U-3745) expiration.
Oct 26, 2031
in 5 yr 5 mo
Patent 12220392 expires
Listed method-of-use patent (U-4306) expiration.
Oct 26, 2031
in 5 yr 5 mo
Patent 12220392 expires
Listed method-of-use patent (U-4307) expiration.
Oct 26, 2031
in 5 yr 5 mo
Patent 11389416 expires
Listed drug product patent expiration.
Jul 17, 2035
in 9 yr 3 mo
Patent 12083087 expires
Listed method-of-use patent (U-3744) expiration.
Jul 17, 2035
in 9 yr 3 mo
Patent 12083087 expires
Listed method-of-use patent (U-3745) expiration.
Jul 17, 2035
in 9 yr 3 mo
Patent 11213498 expires
Listed drug product patent expiration.
Jan 14, 2036
in 9 yr 9 mo
Pharmaceutical detail
Active ingredient
ACETAMINOPHEN; IBUPROFEN SODIUM
Strength
1GM/100ML (10MG/ML);EQ 300MG BASE/100ML (EQ 3MG BASE/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 215320
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Marketing exclusivity (1)
- NPNew product exclusivity (3 years)
Oct 17, 2026
in 4 mo
Listed patents (10)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11446266 | Oct 26, 2031 | in 5 yr 5 mo | U-3744 |
| 11446266 | Oct 26, 2031 | in 5 yr 5 mo | U-3745 |
| 11896567 | Oct 26, 2031 | in 5 yr 5 mo | U-3744 |
| 11896567 | Oct 26, 2031 | in 5 yr 5 mo | U-3745 |
| 12220392 | Oct 26, 2031 | in 5 yr 5 mo | U-4306 |
| 12220392 | Oct 26, 2031 | in 5 yr 5 mo | U-4307 |
| 11389416 | Jul 17, 2035 | in 9 yr 3 mo | Product |
| 12083087 | Jul 17, 2035 | in 9 yr 3 mo | U-3744 |
| 12083087 | Jul 17, 2035 | in 9 yr 3 mo | U-3745 |
| 11213498 | Jan 14, 2036 | in 9 yr 9 mo | Product |
