FDA Orange Book
Generic for Duexis
Duexis contains ibuprofen and famotidine. 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
Yes. The generic name for Duexis is ibuprofen and famotidine. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Duexis products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 26.6MG;800MG | Discontinued | None | 4 | AB |
NDA 022519, held by HORIZON MEDICINES LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic ibuprofen and famotidine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ALKEM LABORATORIES LTD | 211890 | AB (A-rated, therapeutically equivalent) | August 3, 2021 | 26.6MG;800MG |
| ASCENT PHARMACEUTICALS INC | 216814 | AB (A-rated, therapeutically equivalent) | March 15, 2023 | 26.6MG;800MG |
| PH HEALTH LTD | 203658 | AB (A-rated, therapeutically equivalent) | March 22, 2024 | 26.6MG;800MG |
| ZYDUS LIFESCIENCES LTD | 218684 | AB (A-rated, therapeutically equivalent) | February 20, 2025 | 26.6MG;800MG |
Duexis patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8067451 | July 18, 2026 | Drug product | U-1196 | 022519 |
| 8501228 | July 18, 2026 | Method of use | U-1196 | 022519 |
| 8318202 | July 18, 2026 | Drug product | None | 022519 |
| 8309127 | July 18, 2026 | Drug product | None | 022519 |
| 8449910 | July 18, 2026 | Drug product | None | 022519 |
Questions
Is there a generic for Duexis?
Yes. The generic name for Duexis is ibuprofen and famotidine. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Duexis?
The active ingredient in Duexis is ibuprofen and famotidine, per the FDA Orange Book.
When does the Duexis patent expire?
The last patent listed for Duexis in the Orange Book expires July 18, 2026. 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.