# ZETIA — FDA application NDA021445

Informational only - not investment advice.

Application NDA021445 · type NDA · FDA status: approved · original approval 2002-10-25

Listed sponsor: ORGANON · [OGN company profile](/company/OGN/) · exact_unique

Sponsor as listed in Drugs@FDA at retrieval (2026-08-07); FDA sponsor listings can lag ownership transfers.

## FDA application facts

| Product | FDA-listed trade name | Active ingredient | Dosage form | Route | Strength | Marketing status | TE code | RLD |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 001 | ZETIA | EZETIMIBE | TABLET | ORAL | 10MG | Prescription | AB | Yes |

## Orange Book patent and exclusivity listings

- Patent 7612058, product 001; listed patent expiry date: 2025-10-30.
- Patent 7612058, product 001; listed patent expiry date: 2025-10-30.
- Patent 7612058, product 001; listed patent expiry date: 2026-04-30.

Patent and exclusivity dates are regulatory listings from the FDA Orange Book; no relationship to revenue or future sales is stated or implied.

## Compound cross-links

- EZETIMIBE · UNII EOR26LQQ24 · [lmmol compound OLNTVTPDXPETLC-XPWALMASSA-N](https://lmmol.com/compound/OLNTVTPDXPETLC-XPWALMASSA-N)

Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link.

## Related pages

- [Sponsor company](/company/OGN/)
- [FDA-approved application index](/drug/)

Sources: https://www.fda.gov/drugs/drug-approvals-and-databases/drugsfda-data-files · https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files · https://api.fda.gov/drug/drugsfda.json?search=application_number:NDA021445. FDA data retrieved 2026-08-07.

Regulatory listing data as published by FDA; not medical or investment advice.