FDA Orange Book
Is there a generic for Combogesic?
Combogesic 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 (acetaminophen and ibuprofen). The Orange Book shows its last listed patent expires February 27, 2039 and its last listed exclusivity ends March 1, 2026.
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Combogesic products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 325MG;97.5MG | Marketed (Rx) | None | 0 | None |
NDA 209471, held by AFT PHARMACEUTICALS US INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Combogesic patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11534407 | February 27, 2039 | Drug product | U-3553 | 209471 |
| 11197830 | February 27, 2039 | Drug product | U-3553 | 209471 |
Combogesic exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NP | New product | March 1, 2026 | 209471 |
Combogesic NDC codes
Questions
Is there a generic for Combogesic?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Combogesic (acetaminophen and ibuprofen). The Orange Book shows its last listed patent expires February 27, 2039 and its last listed exclusivity ends March 1, 2026.
What is the generic name for Combogesic?
The active ingredient in Combogesic is acetaminophen and ibuprofen, per the FDA Orange Book.
When does the Combogesic patent expire?
The last patent listed for Combogesic in the Orange Book expires February 27, 2039. 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.