apremilast Oral Tablet
- Brand(s)
- Otezla
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Celgene Corporation (2015-06-02)
- Oldest Current Product
- 2014-04-03
- License(s)
- NDA
- RxNORM
- ORAL TABLET\APREMILAST
- FDAOB
- ORAL\TABLET\APREMILAST
- SPL Active
- ORAL\TABLET, FILM COATED\APREMILAST
- SPL Moiety
- ORAL\TABLET, FILM COATED\APREMILAST
product(s) by strength(s)
apremilast 30 mg oral tablet
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 595720631 | Otezla | NDA | Celgene Corporation | 2014-04-03 | APREMILAST | ORAL | TABLET, FILM COATED | NDA205437 | 3acf6751-827d-11e2-9e96-0800200c9a66 |
application(s)
| # | id | title | applicant | approved | patent | exclusivity | approved drug |
|---|---|---|---|---|---|---|---|
| 1 | NDA205437 | OTEZLA | CELGENE CORP | 2014-03-21 | p6020358, USE OF OTEZLA (APREMILAST) FOR INHIBITING PDE4, SUBSTANCE p9018243, USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIATIC ARTHRITIS/ USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIASIS p7208516, USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIATIC ARTHRITIS p7427638, SUBSTANCE p6962940, USE OF OTEZLA (APREMILAST) FOR INHIBITING PDE4 p8802717, USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIATIC ARTHRITIS p7893101, SUBSTANCE p8455536, USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIATIC ARTHRITIS/ USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIASIS p7659302, USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIATIC ARTHRITIS/ USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIASIS | NEW CHEMICAL ENTITY [2019-03-21] TREATMENT OF PATIENTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS WHO ARE CANDIDATES FOR PHOTOTHERAPY OR SYSTEMIC THERAPY [2017-09-23] | NDA205437_001, NDA205437_002, NDA205437_003 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | route | dose form | rld | approved | application |
|---|---|---|---|---|---|---|---|---|
| 1 | NDA205437_001 | RX | APREMILAST (10MG) | ORAL | TABLET | False | 2014-03-21 | OTEZLA |
| 2 | NDA205437_002 | RX | APREMILAST (20MG) | ORAL | TABLET | False | 2014-03-21 | OTEZLA |
| 3 | NDA205437_003 | RX | APREMILAST (30MG) | ORAL | TABLET | True | 2014-03-21 | OTEZLA |
patent(s)
| # | id | expiration date | application(s) |
|---|---|---|---|
| 1 | p6020358 (view patent) | 2018-10-30 | NDA205437 |
| 2 | p6962940 (view patent) | 2023-03-19 | NDA205437 |
| 3 | p7208516 (view patent) | 2023-03-19 | NDA205437 |
| 4 | p7427638 (view patent) | 2024-11-17 | NDA205437 |
| 5 | p7659302 (view patent) | 2023-03-19 | NDA205437 |
| 6 | p7893101 (view patent) | 2023-12-09 | NDA205437 |
| 7 | p8455536 (view patent) | 2023-03-19 | NDA205437 |
| 8 | p8802717 (view patent) | 2023-03-19 | NDA205437 |
| 9 | p9018243 (view patent) | 2023-03-19 | NDA205437 |
spl(s)
| # | id | title | category | type | labeler | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|
| 1 | 3acf6751-827d-11e2-9e96-0800200c9a66 (view SPL) | These highlights do not include all the information needed to use OTEZLA safely and effectively. See full prescribing information for OTEZLA. OTEZLA (apremilast) tablets, for oral use Initial U.S. Approval: 2014 | prescription | Human Prescription | Celgene Corporation | 2015-06-02 | 10 | 595720631, 595720630, 595720632 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII