FDA Orange Book
Is there a generic for Talicia?
Talicia contains omeprazole, amoxicillin and rifabutin. 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 Talicia (omeprazole, amoxicillin and rifabutin). The Orange Book shows its last listed patent expires May 27, 2042 and its last listed exclusivity ends November 1, 2027.
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Talicia products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, delayed release, oral | 250MG;EQ 10MG BASE;12.5MG | Marketed (Rx) | None | 0 | None |
NDA 213004, held by TALICIA HOLDINGS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Talicia patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9603806 | February 12, 2034 | Drug product | U-2660 | 213004 |
| 9498445 | February 12, 2034 | Drug product | U-2660 | 213004 |
| 9050263 | February 12, 2034 | Drug product | U-2660 | 213004 |
| 11135172 | February 12, 2034 | Drug product | U-2660 | 213004 |
| 11931463 | February 12, 2034 | Drug product | U-3866 | 213004 |
| 10238606 | February 12, 2034 | Drug product | None | 213004 |
| 11878011 | May 27, 2042 | Method of use | U-3816 | 213004 |
Talicia exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NP | New product | November 1, 2022 | 213004 |
| GAIN | Generating Antibiotic Incentives Now | November 1, 2027 | 213004 |
Talicia NDC codes
Questions
Is there a generic for Talicia?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Talicia (omeprazole, amoxicillin and rifabutin). The Orange Book shows its last listed patent expires May 27, 2042 and its last listed exclusivity ends November 1, 2027.
What is the generic name for Talicia?
The active ingredient in Talicia is omeprazole, amoxicillin and rifabutin, per the FDA Orange Book.
When does the Talicia patent expire?
The last patent listed for Talicia in the Orange Book expires May 27, 2042. 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.