Prescription medicine
Apremilast Brand names: Otezla
Apremilast (Otezla) is a prescription medicine with an FDA approval on record since 2014. No generic is listed; pharmacies paid $90.57 per Otezla 30 mg tablet in the October 7, 2026 NADAC survey.
- No generic listed
Check it at the source: the apremilast FDA label on DailyMed (effective September 2, 2026, Amgen, Inc); the NDA 205437 record on Drugs@FDA; every apremilast label on DailyMed.
Highlights of the record
FDA label of September 2, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageOTEZLA/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 cand
Forms and strengths
- 20 mg
- 30 mg
- 75 mg
Kit; film-coated tablet.
On the market
- Earliest approval on file
- March 21, 2014 Otezla, Amgen Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 13 first February 17, 2021; 5 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- November 29, 2034 Otezla tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $90.57 per tablet Otezla 30 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 145,481 through July 30, 2026
What is apremilast used for?
From the label: indications and usageOTEZLA/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. […]
Conditions named in the indications of apremilast's FDA labels, with every medicine labeled for each:
From other apremilast labelsPsoriasis: Plaque Psoriasis OTEZLA/OTEZLA XR is indicated for the treatment of adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy.
FDA pharmacologic class: Phosphodiesterase 4 Inhibitor.
Source: FDA drug label (Otezla), Amgen, Inc, effective September 2, 2026 (SPL set f6b1f516-4972-4d82-bced-113e47b41cc5), via openFDA; the full label on DailyMed
Is there a generic for apremilast (Otezla)?
The FDA approved the first generic apremilast on February 17, 2021. 13 generic applications are approved; 5 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
The Orange Book lists 4 patents for Otezla tablets: the compound patent runs to February 16, 2028 (pediatric exclusivity to August 16, 2028), and the last listed entry to November 29, 2034; a patent listed only for Otezla XR tablets runs to May 27, 2042. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2014 earliest approval on file
- 2021 first generic approved
- 2034 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for apremilast (Otezla)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $90.57 per Otezla 30 mg tablet, up 5% from $86.38 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Otezla 20 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Otezla 10-20-30 mg start 28 day | Brand | $98.55 per unit | n/a | +5% |
| Otezla 20 mg tablet | Brand | $89.95 per tablet | $2,698.56 | n/a |
| Otezla 30 mg tablet | Brand | $90.57 per tablet | $2,717.15 | +5% |
| Otezla XR 75 mg tablet | Brand | $181.20 per tablet | $5,435.86 | n/a |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the apremilast label say about other medicines?
The apremilast label names 4 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Carbamazepine | warnings and precautions | Use with strong cytochrome P450 enzyme inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin) is not recommended because loss of efficacy may occur |
| Phenobarbital | warnings and precautions | Use with strong cytochrome P450 enzyme inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin) is not recommended because loss of efficacy may occur |
| Phenytoin | warnings and precautions | Use with strong cytochrome P450 enzyme inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin) is not recommended because loss of efficacy may occur |
| Rifampin | drug interactions | DRUG INTERACTIONS 7.1 Strong CYP450 Inducers Co-administration with strong CYP450 inducers (such as rifampin) decreases apremilast exposure and may result in loss of efficacy of OTEZLA/OTEZLA XR [see Warnings and Precautions (5.5) and Clinical Pharmacology (12.3) ]. |
Source: FDA drug label (Otezla), Amgen, Inc, effective September 2, 2026 (SPL set f6b1f516-4972-4d82-bced-113e47b41cc5), via openFDA; the full label on DailyMed
What do FAERS reports show for apremilast?
The FDA Adverse Event Reporting System holds 145,481 reports that list apremilast among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 5,952 are coded as a death and 11,497 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as apremilast?
5 other medicines are given the same way (oral) and in the same FDA class as apremilast or labeled mainly for the same use (psoriasis), the same class first. Psoriasis lists all 38 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Roflumilast | Psoriasis | 16 labelers | $0.311 per tablet 500 mcg tablet | No current entry |
| Acitretin | Psoriasis | 8 labelers | $2.59 per capsule 10 mg capsule | No current entry |
| Deucravacitinib | Psoriasis | none listed | n/a | No current entry |
| Icotrokinra | Psoriasis | none listed | n/a | No current entry |
| Methoxsalen | Psoriasis | 1 labeler | n/a | No current entry |
Every medicine labeled for the same conditions as apremilast
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does apremilast compare with medicines for the same use?
1 side-by-side page set apremilast beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to apremilast
- 5 medicines for the same use
- Other phosphodiesterase 4 inhibitors
- the pharmacologic class, with prices and generics
- Apremilast side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other