OTEZLA — FDA application NDA205437
Listed sponsor: AMGEN INC · AMGN company profile · 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 | APREMILAST | TABLET | ORAL | 10MG | Prescription | AB | Yes |
| 002 | OTEZLA | APREMILAST | TABLET | ORAL | 20MG | Prescription | AB | Yes |
| 003 | OTEZLA | APREMILAST | TABLET | ORAL | 30MG | Prescription | AB | Yes |
Product, form, strength, reference-drug and marketing-status fields: Drugs@FDA data files; TE and RLD fields: Orange Book data files. Retrieved 2026-08-07.
Orange Book patent and exclusivity listings
| Listing | Product | Descriptive date | Flags/code |
|---|---|---|---|
| Patent 7427638 | 001 | listed patent expiry date: 2028-02-16 | drug substance, drug product |
| Patent 7427638 | 002 | listed patent expiry date: 2028-02-16 | drug substance, drug product |
| Patent 7427638 | 003 | listed patent expiry date: 2028-02-16 | drug substance, drug product |
| Patent 7427638 | 001 | listed patent expiry date: 2028-08-16 | pediatric extension |
| Patent 7427638 | 002 | listed patent expiry date: 2028-08-16 | pediatric extension |
| Patent 7427638 | 003 | listed patent expiry date: 2028-08-16 | pediatric extension |
| Patent 12576034 | 001 | listed patent expiry date: 2033-11-30 | drug product, U-4291 |
| Patent 12576034 | 001 | listed patent expiry date: 2033-11-30 | drug product, U-1858 |
| Patent 12576034 | 001 | listed patent expiry date: 2033-11-30 | drug product, U-4290 |
| Patent 12576034 | 002 | listed patent expiry date: 2033-11-30 | drug product, U-4291 |
| Patent 12576034 | 002 | listed patent expiry date: 2033-11-30 | drug product, U-1858 |
| Patent 12576034 | 002 | listed patent expiry date: 2033-11-30 | drug product, U-4290 |
| Patent 12576034 | 003 | listed patent expiry date: 2033-11-30 | drug product, U-4291 |
| Patent 12576034 | 003 | listed patent expiry date: 2033-11-30 | drug product, U-1858 |
| Patent 12576034 | 003 | listed patent expiry date: 2033-11-30 | drug product, U-4290 |
| Patent 10092541 | 001 | listed patent expiry date: 2034-05-29 | U-2403 |
| Patent 10092541 | 001 | listed patent expiry date: 2034-05-29 | U-2659 |
| Patent 10092541 | 002 | listed patent expiry date: 2034-05-29 | U-2659 |
| Patent 10092541 | 002 | listed patent expiry date: 2034-05-29 | U-2403 |
| Patent 10092541 | 003 | listed patent expiry date: 2034-05-29 | U-2403 |
| Patent 10092541 | 003 | listed patent expiry date: 2034-05-29 | U-2659 |
| Patent 9872854 | 001 | listed patent expiry date: 2034-05-29 | U-2232 |
| Patent 9872854 | 001 | listed patent expiry date: 2034-05-29 | U-2233 |
| Patent 9872854 | 002 | listed patent expiry date: 2034-05-29 | U-2232 |
| Patent 9872854 | 002 | listed patent expiry date: 2034-05-29 | U-2233 |
| Patent 9872854 | 003 | listed patent expiry date: 2034-05-29 | U-2232 |
| Patent 9872854 | 003 | listed patent expiry date: 2034-05-29 | U-2233 |
| Patent 12576034 | 001 | listed patent expiry date: 2034-05-30 | pediatric extension |
| Patent 12576034 | 002 | listed patent expiry date: 2034-05-30 | pediatric extension |
| Patent 12576034 | 003 | listed patent expiry date: 2034-05-30 | pediatric extension |
| Patent 10092541 | 001 | listed patent expiry date: 2034-11-29 | pediatric extension |
| Patent 10092541 | 002 | listed patent expiry date: 2034-11-29 | pediatric extension |
| Patent 10092541 | 003 | listed patent expiry date: 2034-11-29 | pediatric extension |
| Patent 9872854 | 001 | listed patent expiry date: 2034-11-29 | pediatric extension |
| Patent 9872854 | 002 | listed patent expiry date: 2034-11-29 | pediatric extension |
| Patent 9872854 | 003 | listed patent expiry date: 2034-11-29 | pediatric extension |
| Exclusivity ODE-248 | 001 | listed exclusivity date: 2026-07-19 | FDA code as listed |
| Exclusivity ODE-248 | 002 | listed exclusivity date: 2026-07-19 | FDA code as listed |
| Exclusivity ODE-248 | 003 | listed exclusivity date: 2026-07-19 | FDA code as listed |
| Exclusivity M-299 | 001 | listed exclusivity date: 2026-07-20 | FDA code as listed |
| Exclusivity M-299 | 002 | listed exclusivity date: 2026-07-20 | FDA code as listed |
| Exclusivity M-299 | 003 | listed exclusivity date: 2026-07-20 | FDA code as listed |
| Exclusivity PED | 001 | listed exclusivity date: 2027-01-19 | FDA code as listed |
| Exclusivity PED | 002 | listed exclusivity date: 2027-01-19 | FDA code as listed |
| Exclusivity PED | 003 | listed exclusivity date: 2027-01-19 | FDA code as listed |
| Exclusivity PED | 001 | listed exclusivity date: 2027-01-20 | FDA code as listed |
| Exclusivity PED | 002 | listed exclusivity date: 2027-01-20 | FDA code as listed |
| Exclusivity PED | 003 | listed exclusivity date: 2027-01-20 | FDA code as listed |
| Exclusivity NPP | 001 | listed exclusivity date: 2027-04-25 | FDA code as listed |
| Exclusivity NPP | 002 | listed exclusivity date: 2027-04-25 | FDA code as listed |
| Exclusivity NPP | 003 | listed exclusivity date: 2027-04-25 | FDA code as listed |
| Exclusivity PED | 001 | listed exclusivity date: 2027-10-25 | FDA code as listed |
| Exclusivity PED | 002 | listed exclusivity date: 2027-10-25 | FDA code as listed |
| Exclusivity PED | 003 | listed exclusivity date: 2027-10-25 | FDA code as listed |
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 UP7QBP99PN · lmmol compound IMOZEMNVLZVGJZ-QGZVFWFLSA-N · CHEMBL514800
Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link.
Related pages
Sponsor company · FDA-approved application index
Peer clusters: Large-cap biopharma
Sources: Drugs@FDA · Orange Book · openFDA application record. FDA data retrieved 2026-08-07.
Regulatory listing data as published by FDA; not medical or investment advice.