FDA Orange Book
Generic for Zetia
Zetia contains ezetimibe. 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 Zetia is ezetimibe. 11 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
Run it in Rivvi
Map Zetia and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Zetia products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 10MG | Marketed (Rx) | AB | 11 | AB |
NDA 021445, held by ORGANON LLC A SUB OF ORGANON AND CO. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic ezetimibe
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| GLENMARK PHARMACEUTICALS LTD | 078560 | AB (A-rated, therapeutically equivalent) | June 26, 2015 | 10MG |
| AMNEAL PHARMACEUTICALS CO GMBH | 208803 | AB (A-rated, therapeutically equivalent) | June 12, 2017 | 10MG |
| OHM LABORATORIES INC | 207311 | AB (A-rated, therapeutically equivalent) | June 12, 2017 | 10MG |
| SANDOZ INC | 203931 | AB (A-rated, therapeutically equivalent) | June 12, 2017 | 10MG |
| ZYDUS PHARMACEUTICALS USA INC | 204331 | AB (A-rated, therapeutically equivalent) | June 12, 2017 | 10MG |
| AUROBINDO PHARMA LTD | 209838 | AB (A-rated, therapeutically equivalent) | August 25, 2017 | 10MG |
| ALKEM LABORATORIES LTD | 209234 | AB (A-rated, therapeutically equivalent) | December 21, 2017 | 10MG |
| ACCORD HEALTHCARE INC | 211550 | AB (A-rated, therapeutically equivalent) | October 26, 2018 | 10MG |
| SCIEGEN PHARMACEUTICALS INC | 210673 | AB (A-rated, therapeutically equivalent) | October 23, 2020 | 10MG |
| HETERO LABS LTD UNIT III | 210859 | AB (A-rated, therapeutically equivalent) | July 26, 2022 | 10MG |
| ORIENT PHARMA CO LTD | 215693 | AB (A-rated, therapeutically equivalent) | September 13, 2022 | 10MG |
Zetia patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7612058 | October 30, 2025 | Method of use | U-1173 | 021445 |
| 7612058 | October 30, 2025 | Method of use | U-1027 | 021445 |
| 7612058*PED | April 30, 2026 | Method of use | None | 021445 |
Zetia NDC codes
Questions
Is there a generic for Zetia?
Yes. The generic name for Zetia is ezetimibe. 11 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 Zetia?
The active ingredient in Zetia is ezetimibe, per the FDA Orange Book.
When does the Zetia patent expire?
The last patent listed for Zetia in the Orange Book expires April 30, 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.