FDA Orange Book
Is there a generic for Combogesic IV?
Combogesic IV contains acetaminophen and ibuprofen. 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 Combogesic IV (acetaminophen and ibuprofen). The Orange Book shows its last listed patent expires January 14, 2036 and its last listed exclusivity ends October 17, 2026.
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Combogesic IV products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, intravenous | 1GM/100ML (10MG/ML);EQ 300MG BASE/100ML (EQ 3MG BASE/ML) | Marketed (Rx) | None | 0 | None |
NDA 215320, held by HIKMA PHARMACEUTICALS USA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Combogesic IV patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 12220392 | October 26, 2031 | Method of use | U-4306 | 215320 |
| 12220392 | October 26, 2031 | Method of use | U-4307 | 215320 |
| 11446266 | October 26, 2031 | Method of use | U-3744 | 215320 |
| 11446266 | October 26, 2031 | Method of use | U-3745 | 215320 |
| 11896567 | October 26, 2031 | Method of use | U-3744 | 215320 |
| 11896567 | October 26, 2031 | Method of use | U-3745 | 215320 |
| 12083087 | July 17, 2035 | Method of use | U-3744 | 215320 |
| 12083087 | July 17, 2035 | Method of use | U-3745 | 215320 |
| 11389416 | July 17, 2035 | Drug product | None | 215320 |
| 11213498 | January 14, 2036 | Drug product | None | 215320 |
Combogesic IV exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NP | New product | October 17, 2026 | 215320 |
Combogesic IV NDC codes
Questions
Is there a generic for Combogesic IV?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Combogesic IV (acetaminophen and ibuprofen). The Orange Book shows its last listed patent expires January 14, 2036 and its last listed exclusivity ends October 17, 2026.
What is the generic name for Combogesic IV?
The active ingredient in Combogesic IV is acetaminophen and ibuprofen, per the FDA Orange Book.
When does the Combogesic IV patent expire?
The last patent listed for Combogesic IV in the Orange Book expires January 14, 2036. 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.