Treats active psoriatic arthritis. Sold as Otezla, Otezla Xr. Every FDA application for this active ingredient: 3 branded and 14 generic.
As of Nov 13, 2026, FDA lists 17 applications for Apremilast (sold as Otezla, Otezla Xr), first approved Mar 21, 2014, with 6 new uses approved and 0 published complete response letters.
| Otezla | Part D | $1.38B | +32% | 37,421 |
| Otezla XR | Part D | $1.2M | New | 159 |
| Comparing the Extent to Which Apremilast is Made Available in the Body After Administration as an Extended-release or Immediate-release FormulationPsoriasis, Arthritis, Psoriatic · Amgen | Phase 1 | Not yet recruiting | Nov 2, 2026 |
| Apremilast Added to Antihistamines in Chronic UrticariaChronic Urticaria, Chronic Spontaneous Urticaria · Rashid Latif Medical College | Phase 2 | Enrolling by invitation | Sep 30, 2026 |
| EFFICACY OF ROFLUMILAST IN THE TREATMENT OF FLEXURAL AND/OR GENITAL PSORIASIS: A RANDOMIZED CONTROLLED TRIAL.Flexural Psoriasis (Also Known as Inverse or Intertriginous Psoriasis) and Genital Psoriasis · Eman Raafat Said | Phase 2 | Not yet recruiting | Apr 22, 2026 |
| Methotrexate Versus Apremilast for Pruritus in PsoriasisPsoriasis, Pruritus · Zarmeen Khawar | Phase 4 | Not yet recruiting | Feb 25, 2026 |
| Apremilast and Adalimumab in Psoriatic Arthritis PatientsPsoriatic Arthritis, Ultrasound Assessment · Tanta University | Not applicable | Not yet recruiting | Feb 10, 2026 |
| Evaluation the Topical Apremilast Nanoformulation in Treatment of Localized Plaque PsoriasisPsoriasis · Assiut University | Not applicable | Not yet recruiting | Jan 26, 2026 |
| Utilization of a Microdevice for Psoriasis and Atopic DermatitisPsoriasis, Atopic Dermatitis · University of California, San Francisco | Phase 4 | Not yet recruiting | Jan 20, 2026 |
| To Check Comparison of Apremilast and Methotrexate Efficacy in Patients With Moderate to Severe Plaque Psoriasis Presented to Tertiary Care HospitalChronic Plaque Psoriasis · Syeda Sana Zaman | Early phase 1 | Recruiting | Jan 13, 2026 |
| Mar 21, 2014 | OtezlaNDA 205437 · New molecular entity | Amgen Inc | 13 | Marketed |
| Sep 23, 2014 | OtezlaNDA 206088 · New indication | Celgene Corp | 0 | Marketed |
| Feb 17, 2021 | ApremilastANDA 211819 | Unichem | 0 | Discontinued |
| Jun 30, 2021 | ApremilastANDA 211782 | Amneal | 0 | Discontinued |
| Sep 21, 2021 | ApremilastANDA 211761 | Alkem Labs Ltd | 0 | Marketed |
| Aug 18, 2022 | ApremilastANDA 211897 | Teva Pharms USA Inc | 0 | Discontinued |
| Apr 7, 2023 | ApremilastANDA 211774 | Shilpa | 0 | Marketed |
| Jul 14, 2023 | ApremilastANDA 211756 | Dr Reddys | 0 | Discontinued |
| Jul 19, 2023 | ApremilastANDA 211716 | Aurobindo Pharma Ltd | 0 | Discontinued |
| Jul 26, 2023 | ApremilastANDA 211878 | Annora | 0 | Marketed |
| Oct 16, 2023 | ApremilastANDA 211674 | Glenmark Pharms Ltd | 0 | Discontinued |
| Feb 7, 2024 | ApremilastANDA 211734 | Mankind Pharma | 0 | Marketed |
| Nov 25, 2024 | ApremilastANDA 211788 | Macleods Pharms | 0 | Discontinued |
| Dec 16, 2024 | ApremilastANDA 211887 | Msn | 0 | Marketed |
| Jun 20, 2025 | ApremilastANDA 211834 | Torrent | 0 | Discontinued |
| Aug 29, 2025 | Otezla Xr, OtezlaNDA 210745 · New formulation or manufacturer | Amgen Inc | 0 | Marketed |
| — | ApremilastANDA 211859 | Zydus Pharms | 0 | Discontinued |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
Zydus Pharms