Otezla
An oral medication used to treat plaque psoriasis and psoriatic arthritis.
Where Apremilast is approved
All regulators →Of the three regulators tracked here, the first to approve Apremilast was the US, on 21 Mar 2014. It is approved in 3 of the 3 regulators tracked here.
- 1 EU orphan designation, most recently for treatment of Behçet's Disease (5 Aug 2013, withdrawn)
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
Apremilast patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Apremilast, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 7 listed patents; the last listed expires 27 May 2042 (US 11752129).
- Latest patent on the drug substance itself: 16 Aug 2028 (US 7427638, with paediatric extension).
- Exclusivity PED: Pediatric exclusivity, until 25 Oct 2027.
- Exclusivity NPP: New patient population, until 25 Apr 2027.
- Exclusivity PED: Pediatric exclusivity, until 20 Jan 2027.
- Exclusivity PED: Pediatric exclusivity, until 19 Jan 2027.
Reproduced from the FDA Orange Book and Purple Book (checked 5 Oct 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
What health systems spend on Apremilast
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Apremilast works
All drug targets →- Phosphodiesterase 4 inhibitor InhibitorTarget: Phosphodiesterase 4✓ In ChEMBL and the Guide to Pharmacology
- COVID-19Phase 3
- Recurrent aphthous stomatitisPhase 3
- Ankylosing spondylitisPhase 3
- Palmoplantar pustulosisPhase 3
- Psoriasis-related juvenile idiopathic arthritisPhase 3
- Skin sarcoidosisPhase 2/3
- AcnePhase 2
- Acute respiratory failurePhase 2
- Alcohol dependencePhase 2
- Allergic contact dermatitisPhase 2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL514800, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3), ligand 7372, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
NICE appraisals of Apremilast
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 3 technology appraisals of Apremilast. 3 are current, and 2 of these recommend it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Apremilast for treating active psoriatic arthritis NICE TA433 | Optimised | 22 Feb 2017 | Current |
| Apremilast for treating moderate to severe plaque psoriasis NICE TA419 | Recommended | 23 Nov 2016 | Current |
| Apremilast for treating moderate to severe plaque psoriasis NICE TA368 | Not recommended | 25 Nov 2015 | Current |
NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
Patient leaflets for Apremilast
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 13 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: Otezla, Apremilast Accord (generic)EMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Apremilast
- ATC code
- L04AA32
- ChEMBL
- CHEMBL514800
- DrugBank
- DB05676
- PubChem CID
- 11561674
- CAS number
- 608141-41-9
- FDA UNII
- UP7QBP99PN
- Wikidata
- Q2858961
- Wikipedia
- Apremilast
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
What Otezla is used for
OTEZLA/OTEZLA XR, an inhibitor of phosphodiesterase 4 (PDE4), is indicated for the treatment of: Adult patients with: Active psoriatic arthritis ( 1.1 ) Plaque psoriasis who are candidates for phototherapy or systemic therapy ( 1.2 ) Oral ulcers associated with Behçet's Disease ( 1.3 ) Pediatric patients 6 years of age and older with: Active psoriatic arthritis ( 1.1 ) Moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy ( 1.2 ) In the pediatric population, OTEZLA is indicated for patients weighing at least 20 kg, and OTEZLA XR is indicated for patients weighing at least 50 kg. 1.1 Psoriatic Arthritis OTEZLA is indicated for the treatment of adult patients and pediatric patients 6 years of age and older and weighing at least 20 kg with active psoriatic arthritis. OTEZLA XR is indicated for the treatment of adult patients and pediatric patients 6 ye…
How it works
12.1 Mechanism of Action Apremilast is an oral small molecule inhibitor of phosphodiesterase 4 (PDE4) specific for cyclic adenosine monophosphate (cAMP). PDE4 inhibition results in increased intracellular cAMP levels. The specific mechanism(s) by which apremilast exerts its therapeutic action is not well defined.
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How this page is built
The facts on this page are pulled directly from official U.S. FDA datasets — they are not written from memory. Each field below names the dataset it came from, so you can check it yourself.
- FDA Drug Label (openFDA) ↗ Indications, mechanism of action and pharmacologic class
- Drugs@FDA ↗ First FDA approval date and the company holding the application
- FDA Drug Shortage Database ↗ Current US supply / shortage status
Plain-English summaries and drug-class explainers are written and reviewed by Sreepriya Prasannan (MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany). Data is retrieved automatically from the sources above and cross-checked with AI-assisted verification (Anthropic's Claude) — brand and generic names are matched against the exact FDA product record so that a combination product or a different formulation cannot be mistaken for the drug on this page. An editor reviews the result before publication. We describe this in full in our editorial standards and corrections policy. The FDA data on this page was last retrieved on 7 Oct 2026. How every register is built: methodology · fixes we have made: corrections log.