FDA Orange Book
Generic for Moxeza
Moxeza contains moxifloxacin. 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 Moxeza is moxifloxacin. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AT1.
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Moxeza products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution/drops, ophthalmic | EQ 0.5% BASE | Discontinued | None | 10 | AT1 |
NDA 022428, held by HARROW EYE LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic moxifloxacin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| LUPIN LTD | 202867 | AT1 (A-rated, therapeutically equivalent) | September 4, 2014 | EQ 0.5% BASE |
| REGCON HOLDINGS LLC | 202525 | AT1 (A-rated, therapeutically equivalent) | March 6, 2015 | EQ 0.5% BASE |
| LUPIN LTD | 204079 | None (No TE code listed) | May 28, 2015 | EQ 0.5% BASE |
| APOTEX INC | 090080 | AT1 (A-rated, therapeutically equivalent) | June 30, 2017 | EQ 0.5% BASE |
| EUGIA PHARMA SPECIALITIES LTD | 206242 | AT1 (A-rated, therapeutically equivalent) | October 4, 2017 | EQ 0.5% BASE |
| ALEMBIC PHARMACEUTICALS LTD | 209469 | AT1 (A-rated, therapeutically equivalent) | February 13, 2019 | EQ 0.5% BASE |
| GLAND PHARMA LTD | 208778 | AT1 (A-rated, therapeutically equivalent) | March 30, 2020 | EQ 0.5% BASE |
| UPSHER SMITH LABORATORIES LLC | 212616 | AT1 (A-rated, therapeutically equivalent) | February 10, 2021 | EQ 0.5% BASE |
| SOMERSET THERAPEUTICS LLC | 209698 | AT1 (A-rated, therapeutically equivalent) | November 14, 2024 | EQ 0.5% BASE |
| MANKIND PHARMA LTD | 217988 | AT1 (A-rated, therapeutically equivalent) | January 27, 2025 | EQ 0.5% BASE |
Moxeza patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9114168 | May 29, 2029 | Drug product | None | 022428 |
| 8450311 | May 29, 2029 | Drug product | None | 022428 |
Questions
Is there a generic for Moxeza?
Yes. The generic name for Moxeza is moxifloxacin. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AT1.
What is the generic name for Moxeza?
The active ingredient in Moxeza is moxifloxacin, per the FDA Orange Book.
When does the Moxeza patent expire?
The last patent listed for Moxeza in the Orange Book expires May 29, 2029. 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.