# OTEZLA / OTEZLA XR — FDA application NDA210745

Informational only - not investment advice.

Application NDA210745 · type NDA · FDA status: approved · original approval 2025-08-29

Listed sponsor: AMGEN INC · [AMGN company profile](/company/AMGN/) · 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 | OTEZLA XR | APREMILAST | TABLET, EXTENDED RELEASE | ORAL | 75MG | Prescription | not listed | Yes |
| 002 | OTEZLA | APREMILAST | TABLET | ORAL | 10MG | Prescription | not listed | not listed |
| 003 | OTEZLA | APREMILAST | TABLET | ORAL | 20MG | Prescription | not listed | not listed |
| 005 | OTEZLA | APREMILAST | TABLET | ORAL | 30MG | Prescription | not listed | not listed |

## Orange Book patent and exclusivity listings

- Patent 7427638, product 001; listed patent expiry date: 2028-02-16.
- Patent 10092541, product 001; listed patent expiry date: 2034-05-29.
- Patent 11752129, product 001; listed patent expiry date: 2042-05-27.
- Patent 11752129, product 001; listed patent expiry date: 2042-05-27.
- Patent 11752129, product 001; listed patent expiry date: 2042-05-27.
- Patent 11969409, product 001; listed patent expiry date: 2042-05-27.
- Patent 12427136, product 001; listed patent expiry date: 2042-05-27.
- Patent 12427136, product 001; listed patent expiry date: 2042-05-27.
- Patent 12427136, product 001; listed patent expiry date: 2042-05-27.
- Exclusivity ODE*, product 001; listed exclusivity date: 2026-07-19.
- Exclusivity M-299, product 001; listed exclusivity date: 2026-07-20.
- Exclusivity PED, product 001; listed exclusivity date: 2027-01-19.
- Exclusivity PED, product 001; listed exclusivity date: 2027-01-20.

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

- APREMILAST · UNII not resolved · no lmmol compound match

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/AMGN/)
- [FDA-approved application index](/drug/)
- [Large-cap biopharma](/compare/pharma/)

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:NDA210745. FDA data retrieved 2026-08-07.

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