Generic Otezla (Apremilast): Is It Available in the US, What It Costs, Dosing and Side Effects
Lokesh Maurya
Generic Otezla (Apremilast): Is It Available in the US, What It Costs, Dosing and Side Effects - pharmacy guide
In this article (27 sections)
Otezla is Amgen's brand of apremilast, a tablet taken by mouth for plaque psoriasis, psoriatic arthritis and the mouth ulcers of Behçet's disease. People search for "generic Otezla" for one reason: the brand is expensive. In the federal NADAC price survey dated 21 October 2026, US pharmacies paid $90.58800 for a single Otezla 30 mg tablet, which is $5,435.28 for the 60 tablets in a month at the usual dose.
This guide answers the question in the title with dates from FDA databases, then covers what apremilast is, who the US label says it is for, the 5-day start-up schedule, the kidney dose rule, how well it worked in the label's trials, its side effects and warnings, and what it costs. We sell Indian apremilast tablets listed with Glenmark and Prevego as the makers, so we have a commercial interest; every figure here comes from the FDA label, FDA and CMS databases, company filings or published trials listed under Sources. Do not start, stop or switch a psoriasis or arthritis medicine without your doctor.
The short answer
No generic Otezla is on sale in US pharmacies as of 26 October 2026. The FDA has approved generic apremilast tablets from 13 companies, and one more holds a tentative approval, but approval and sale are different steps. The FDA's NDC directory lists no finished generic apremilast tablets, only Amgen's Otezla products, and the 2026 NADAC price file, which records what pharmacies pay each week, has no generic apremilast entry at all. Patents explain why: Amgen won a court ruling that blocks two generic makers until February 2028, and its own annual report lists the key US patent running to 16 February 2028 with pediatric exclusivity to 16 August 2028.
Outside the US, apremilast is made and sold by several companies. In India, for example, it is sold as Aprezo, listed with Glenmark as the maker. Those tablets are not FDA-approved products, and the FDA's rules on bringing medicines into the US for personal use are covered further down.
What apremilast is
Apremilast is a small molecule that blocks phosphodiesterase 4 (PDE4), an enzyme inside immune cells that breaks down a signalling molecule called cyclic AMP. With PDE4 blocked, cyclic AMP levels rise. The label says the exact way this treats psoriasis "is not well defined"; in studies, apremilast lowered blood levels of the inflammatory messengers IL-17, IL-22 and TNF-alpha and reduced their activity in skin, though the label adds that the clinical meaning of this is unclear.
Unlike biologic medicines for psoriasis, apremilast is a tablet rather than an injection. The body absorbs about 73% of a dose, peak blood levels arrive about 2.5 hours after a tablet, and food does not change how much is absorbed. The FDA first approved Otezla on 21 March 2014 (NDA 205437, originally held by Celgene, now Amgen).
What the US label approves it for
The current Otezla label (DailyMed version published 11 September 2026) lists three uses:
- Psoriatic arthritis: adults, and children 6 years and older who weigh at least 20 kg, with active psoriatic arthritis.
- Plaque psoriasis: adults with plaque psoriasis who are candidates for phototherapy or systemic therapy, and children 6 years and older weighing at least 20 kg with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
- Behçet's disease: adults with oral ulcers associated with Behçet's disease.
The adult psoriasis use is not limited to severe disease: the label includes a trial in adults with mild to moderate psoriasis, as well as trials focused on scalp and genital psoriasis. The label states that safety and effectiveness have not been established in children under 6, in children under 20 kg, or in children with Behçet's disease.
Otezla and Otezla XR
On 29 August 2025 the FDA approved Otezla XR (NDA 210745), a 75 mg extended-release tablet taken once a day. The label says Otezla XR 75 mg once daily gives blood levels comparable to Otezla 30 mg twice daily. It is approved for the same adult uses and for children 6 and older who weigh at least 50 kg with moderate to severe plaque psoriasis (candidates for phototherapy or systemic therapy) or active psoriatic arthritis. The 5-day start-up still uses regular Otezla tablets. Otezla XR is not recommended in severe kidney impairment.
No generic of Otezla XR has been approved: the Drugs@FDA records for apremilast show generic approvals only for the 10, 20 and 30 mg immediate-release tablets.
Is there a generic Otezla? The FDA record
Drugs@FDA, searched through openFDA on 26 October 2026, lists these abbreviated new drug applications (ANDAs) for apremilast 10, 20 and 30 mg tablets. The status column is the marketing status the FDA lists; it is not proof that a product is in pharmacies.
| Company | ANDA | Approval date | Status in Drugs@FDA |
|---|---|---|---|
| Unichem | 211819 | 17 Feb 2021 | Discontinued |
| Amneal | 211782 | 30 Jun 2021 | Discontinued |
| Alkem | 211761 | 21 Sep 2021 | Prescription |
| Zydus | 211859 | 3 Feb 2022 | Tentative approval |
| Teva | 211897 | 18 Aug 2022 | Discontinued |
| Shilpa | 211774 | 7 Apr 2023 | Prescription |
| Dr. Reddy's | 211756 | 14 Jul 2023 | Discontinued |
| Aurobindo | 211716 | 19 Jul 2023 | Discontinued |
| Annora | 211878 | 26 Jul 2023 | Prescription |
| Glenmark | 211674 | 16 Oct 2023 | Discontinued |
| Mankind | 211734 | 7 Feb 2024 | Prescription |
| Macleods | 211788 | 25 Nov 2024 | Discontinued |
| MSN | 211887 | 16 Dec 2024 | Prescription |
| Torrent | 211834 | 20 Jun 2025 | Discontinued |
So 13 companies hold full approval and Zydus holds a tentative one. Two other public records show that none of these is on sale yet. The FDA's NDC directory, which lists products a company has registered for sale, contains apremilast entries for Amgen's Otezla packs, for bulk ingredient suppliers and for contract manufacturers' "for further processing" listings, but no finished generic apremilast tablets. And the 2026 NADAC file from CMS, searched for every product description starting with "APREMILAST" through the week of 21 October 2026, returned no rows. For comparison, generic Janumet tablets showed up in NADAC in August 2026, about ten weeks after their listed marketing start (see our generic Janumet guide).
Why generics are not on sale: the patents
Two primary sources explain the timing. In April 2023, Amgen announced that the US Court of Appeals for the Federal Circuit had affirmed a permanent injunction "prohibiting Sandoz and Zydus from making, using, selling, offering to sell, or importing each of their generic versions of Otezla until February 2028." The court upheld US Patent No. 7,427,638, which claims pharmaceutical compositions of apremilast, and a crystalline form patent, but ruled against Amgen on a dosing-schedule patent.
Amgen's 2024 annual report (Form 10-K) lists the US Otezla compositions and compounds patent as expiring on 16 February 2028, with a footnote that "pediatric exclusivity" was "granted to 8/16/2028 for a patent with this subject matter." Other generic makers may have settled with Amgen on their own terms, but we did not find those terms in a court record or company release we could check, so we do not give a launch date. What can be said from the records: no generic is sold today, and the compositions patent and its pediatric extension run into 2028.
Medicare's negotiated price from 2027
Otezla is one of 15 drugs in the second round of Medicare drug price negotiation. The CMS fact sheet for 2027 lists a negotiated price of $1,650 for a 30-day supply of Otezla and Otezla XR, against a list price of $4,722 for a 30-day supply (the wholesale acquisition cost based on 2024 prescription fills), a 65% discount. This price takes effect on 1 January 2027 and applies to Medicare Part D. It does not set what people with commercial insurance or no insurance pay.
How the dose is started: the 5-day titration
Apremilast is started low and raised over five days because stomach upset is most common at the start. The label's adult schedule:
| Day | Morning | Evening |
|---|---|---|
| Day 1 | 10 mg | none |
| Day 2 | 10 mg | 10 mg |
| Day 3 | 10 mg | 20 mg |
| Day 4 | 20 mg | 20 mg |
| Day 5 | 20 mg | 30 mg |
| Day 6 onward | 30 mg | 30 mg (or Otezla XR 75 mg once daily) |
Children 6 and older who weigh at least 50 kg follow the same schedule and end on 30 mg twice daily (or Otezla XR 75 mg once daily). Children weighing 20 kg to under 50 kg follow the same first four days, take 20 mg in the evening of day 5, and stay on 20 mg twice daily. Tablets can be taken with or without food and must be swallowed whole: the label says do not crush, split or chew them.
The label lists a 28-day starter pack of 55 tablets (four 10 mg, four 20 mg and 47 tablets of 30 mg) for the adult schedule, and bottles of 60 tablets for maintenance.
Kidney dose adjustment
No change is needed in mild or moderate kidney impairment. In severe kidney impairment (creatinine clearance below 30 mL per minute by the Cockcroft-Gault equation), the label says to titrate using only the morning doses in the schedule above, skipping the evening doses, and to use a maintenance dose of 30 mg once daily in adults. For children in this group it is 30 mg once daily if they weigh at least 50 kg and 20 mg once daily if they weigh 20 kg to under 50 kg. Otezla XR is not recommended in severe kidney impairment. No dose change is needed for moderate or severe liver impairment.
How well it works in plaque psoriasis
The two main adult trials, known as ESTEEM 1 and ESTEEM 2 (PSOR-1 and PSOR-2 in the label), randomised 1,257 adults with moderate to severe plaque psoriasis to apremilast 30 mg twice daily or placebo for 16 weeks. On average, patients had psoriasis on about a quarter of their body (mean 25.2%) and a PASI score of 19.1. The main measure was PASI 75: at least a 75% reduction in the Psoriasis Area and Severity Index.
| Trial (week 16) | Measure | Placebo | Apremilast |
|---|---|---|---|
| ESTEEM 1 (N = 282 placebo, 562 apremilast) | PASI 75 | 5.3% | 33.1% |
| ESTEEM 1 | sPGA clear or almost clear | 3.9% | 21.7% |
| ESTEEM 2 (N = 137 placebo, 274 apremilast) | PASI 75 | 5.8% | 28.8% |
| ESTEEM 2 | sPGA clear or almost clear | 4.4% | 20.4% |
| PSOR-6, ages 6 to 17 (N = 82 placebo, 163 apremilast) | PASI 75 | 16.0% | 45.7% |
| PSOR-6 | sPGA response | 10.8% | 33.1% |
In plain terms, about one adult in three reached PASI 75 after four months in ESTEEM 1, against about one in twenty on placebo. In the ESTEEM 1 publication, of the patients re-randomised at week 32 (patients who had reached PASI 75), 61.0% of those kept on apremilast had PASI 75 at week 52 against 11.7% of those switched to placebo, so most patients lost the response after stopping. The label notes that the median time to losing PASI 75 after switching to placebo was 5.1 weeks.
Scalp, genital and milder psoriasis
Three further trials in the label looked at harder-to-treat sites and milder disease, all at 30 mg twice daily for 16 weeks:
| Trial | Main measure at week 16 | Placebo | Apremilast |
|---|---|---|---|
| PSOR-3, scalp psoriasis (N = 303) | Scalp clear or almost clear (ScPGA response) | 13.7% | 43.3% |
| PSOR-5, genital psoriasis (N = 289) | Genital clear or almost clear (modified sPGA-G response) | 19.5% | 39.6% |
| PSOR-4, mild to moderate psoriasis (N = 595) | sPGA response | 4.1% | 21.6% |
Itch also improved: in the scalp trial, 45.5% on apremilast had at least a 4-point fall in whole-body itch score against 22.5% on placebo, and in the genital trial 47.3% against 19.6% had a 4-point fall in genital itch.
How well it works in psoriatic arthritis
Three trials (PsA-1, PsA-2 and PsA-3) enrolled 1,493 adults with active psoriatic arthritis (at least 3 swollen and 3 tender joints) despite previous treatment. Most kept taking their existing medicines, such as methotrexate. The main measure was ACR 20, at least a 20% improvement in joint counts and other measures, at week 16.
| Week 16 response | PsA-1 placebo | PsA-1 apremilast | PsA-2 placebo | PsA-2 apremilast | PsA-3 placebo | PsA-3 apremilast |
|---|---|---|---|---|---|---|
| ACR 20 | 19% | 38% | 19% | 32% | 18% | 41% |
| ACR 50 | 6% | 16% | 5% | 11% | 8% | 15% |
| ACR 70 | 1% | 4% | 1% | 1% | 2% | 4% |
In PsA-1, tender joints fell by an average of 7 on apremilast against 2 on placebo, and swollen joints by 5 against 2. The label also reports improvement in dactylitis (sausage-shaped swelling of fingers or toes) and enthesitis (pain where tendons attach to bone) in patients who had them.
Oral ulcers in Behçet's disease
In the BCT-002 trial, 207 adults with Behçet's disease and active mouth ulcers took apremilast 30 mg twice daily or placebo for 12 weeks. At week 12, 52.9% on apremilast were free of mouth ulcers against 22.3% on placebo. Ulcer pain on a 100-point scale fell by 42.7 points against 18.7, and the average daily number of ulcers over the 12 weeks was 1.5 against 2.6.
Side effects
The most common adverse reactions are stomach-related and usually appear in the first weeks of treatment. In the adult plaque psoriasis trials:
| Adverse reaction (to week 16) | Placebo (N = 506) | Apremilast 30 mg twice daily (N = 920) |
|---|---|---|
| Diarrhea | 6% | 17% |
| Nausea | 7% | 17% |
| Upper respiratory tract infection | 6% | 9% |
| Tension headache | 4% | 8% |
| Headache | 4% | 6% |
| Abdominal pain | 2% | 4% |
| Vomiting | 2% | 4% |
| Decreased appetite | 1% | 3% |
In these trials 6.1% of people on apremilast stopped because of an adverse reaction, against 4.1% on placebo; nausea (1.6%), diarrhea (1.0%) and headache (0.8%) were the most common reasons. In the psoriatic arthritis trials, the label says most common reactions occurred in the first 2 weeks and "tended to resolve over time with continued dosing." Rates were higher in the Behçet's trial, where diarrhea affected 41.3% on apremilast against 20.4% on placebo. Severe worsening of psoriasis (rebound) after stopping occurred in 0.3% (4 of 1,184) of patients.
Warning: severe diarrhea, nausea and vomiting
The label reports severe diarrhea, nausea and vomiting with Otezla, mostly in the first few weeks, and some patients were hospitalised. People aged 65 and over and people taking medicines that can cause dehydration or low blood pressure may be at higher risk of complications. The label advises monitoring these patients and considering a lower dose or a pause if severe symptoms develop; patients who reduced the dose or stopped generally improved quickly.
Warning: depression and suicidal thoughts
The label states that apremilast "is associated with an increased incidence of depression." In the adult psoriasis trials, 1.3% (12 of 920) on apremilast reported depression in the first 16 weeks against 0.4% (2 of 506) on placebo; in the psoriatic arthritis trials it was 1.0% against 0.8%. Suicidal ideation and behaviour were seen in 0.2% (3 of 1,441) of people taking apremilast in the arthritis trials, against none on placebo. Before starting, people with a history of depression or suicidal thoughts should discuss the risks and benefits with their prescriber, and patients, caregivers and families should watch for new or worse depression, suicidal thoughts or mood changes and contact a healthcare provider if they occur.
Warning: weight loss
In the adult moderate to severe psoriasis trials, 12% of people on apremilast lost 5% to 10% of their body weight against 5% on placebo, and 2% lost 10% or more against 1%. In the pediatric trial, 12% on apremilast lost 5% to 10% of body weight against 2.5% on placebo. The label advises regular weight checks, evaluation and possible stopping if weight loss is unexplained or clinically significant, and close monitoring of growth in children.
Drug interactions and who should not take it
Strong enzyme inducers lower apremilast levels and may make it stop working. The label says use with cytochrome P450 enzyme inducers such as rifampin, phenobarbital, carbamazepine and phenytoin "is not recommended."
Apremilast is contraindicated in people with a known hypersensitivity to apremilast or to any of the tablet's ingredients. Allergic reactions including angioedema and anaphylaxis have been reported after marketing. Otezla tablets contain lactose monohydrate among their inactive ingredients; inactive ingredients in other brands can differ, so check the pack leaflet if you react to any excipient.
Pregnancy and breastfeeding
The label says available human data have not identified a drug-associated risk of major birth defects, but the numbers are small: a pregnancy registry had 15 exposed pregnancies. In monkey studies, apremilast caused dose-related increases in miscarriage at about twice the maximum human exposure, and the label says Otezla "may increase the risk for fetal loss." There are no data on apremilast in human breast milk; it was found in the milk of mice. Anyone pregnant, planning pregnancy or breastfeeding should discuss it with their doctor before taking apremilast.
What Otezla costs US pharmacies
NADAC (National Average Drug Acquisition Cost) is a weekly CMS survey of what retail pharmacies pay wholesalers for a drug. It is not the price a patient pays at the counter, which includes pharmacy margins and depends on insurance and coupons. The latest NADAC rows for Otezla, as of 21 October 2026:
| Product | NADAC per tablet | One month | Cost for one month |
|---|---|---|---|
| Otezla 30 mg tablet | $90.58800 | 60 tablets | $5,435.28 |
| Otezla 20 mg tablet | $89.95216 | 60 tablets | $5,397.13 |
| Otezla XR 75 mg tablet | $181.19530 | 30 tablets | $5,435.86 |
A month of Otezla 30 mg twice daily and a month of Otezla XR once daily cost pharmacies almost the same. All rows are classified as brand in the NADAC file; there is no generic apremilast row to compare.
Indian apremilast on SafeRxPills and what it costs
We sell apremilast tablets made for the Indian market: Aprezo 10 mg, Aprezo 20 mg and Aprezo 30 mg, listed with Glenmark Pharmaceuticals as the maker, and Aprecast 30 mg, listed with Prevego Healthcare as the maker. Glenmark also holds a US generic approval for apremilast (ANDA 211674, approved October 2023 and now listed as discontinued in Drugs@FDA), but the Aprezo packs we sell are Indian-market products. They are not FDA-approved, and they are not the product covered by that US approval. Prices as of 26 October 2026:
| Product | Pack | Price | Per tablet |
|---|---|---|---|
| Aprezo 10 mg (Glenmark) | 60 tablets | $43.00 | $0.72 |
| Aprezo 10 mg (Glenmark) | 120 tablets | $78.00 | $0.65 |
| Aprezo 10 mg (Glenmark) | 180 tablets | $105.00 | $0.58 |
| Aprezo 20 mg (Glenmark) | 60 tablets | $55.00 | $0.92 |
| Aprezo 20 mg (Glenmark) | 120 tablets | $95.00 | $0.79 |
| Aprezo 20 mg (Glenmark) | 180 tablets | $132.00 | $0.73 |
| Aprezo 30 mg (Glenmark) | 60 tablets | $64.50 | $1.08 |
| Aprezo 30 mg (Glenmark) | 90 tablets | $78.75 | $0.88 |
| Aprezo 30 mg (Glenmark) | 120 tablets | $102.50 | $0.85 |
| Aprecast 30 mg (Prevego) | 60 tablets | $50.00 | $0.83 |
| Aprecast 30 mg (Prevego) | 90 tablets | $69.00 | $0.77 |
| Aprecast 30 mg (Prevego) | 120 tablets | $88.00 | $0.73 |
The comparison in Figure 4 is lopsided, but read it carefully: one side is a US pharmacy's purchase cost for an FDA-approved brand, the other is our list price for tablets that have not been reviewed by the FDA. Our NADAC brand vs generic price guide explains how to read these numbers for other medicines.
Importing apremilast into the US: what the FDA says
The FDA's personal importation page says: "In most circumstances, it is illegal for individuals to import drugs or devices into the U.S. for personal use because these products purchased from other countries often have not been approved by the FDA for use and sale in the U.S." It continues: "If a drug is approved for use in another country but is an unapproved new drug in the U.S. it is illegal to import." It adds that the FDA cannot vouch for the safety and effectiveness of medicine bought online from foreign sources, and it recommends obtaining medicines from legal sources in the US. The page lists narrow conditions under which FDA staff may use discretion for a prescription medicine, including that effective treatment may not be available in the US and that the product is not commercialized or promoted to people living in the US. FDA-approved apremilast (Otezla) is available in the US. Read the FDA personal importation page and check your own situation before ordering any medicine from outside the US. Our guides on Canadian online pharmacies and whether it is safe to buy medicine online cover the wider risks.
Is Indian apremilast the same as Otezla?
The active ingredient is the same molecule, and Indian packs come in the same 10, 20 and 30 mg strengths. What differs is the regulatory check: a US generic must show the FDA that it is bioequivalent to Otezla and is made to FDA standards, while Aprezo and Aprecast are made for the Indian market and have not been through that US review. Inactive ingredients, tablet shape and color can differ from the brand. For background on how generic equivalence is judged, see our guide on whether generic and brand medicines are the same.
Where apremilast fits among psoriasis treatments
Apremilast is a systemic treatment: it works through the whole body rather than on the skin surface. The US label approves it in psoriasis for people who are "candidates for phototherapy or systemic therapy", meaning disease that a doctor judges needs more than creams and ointments. Injectable biologics are another systemic option; the label trials compared apremilast with placebo, not with biologics, so these figures cannot rank it against them. Our prescription skin care medicine guide gives an overview of other prescription skin treatments.
Questions to ask your doctor or pharmacist
- Is apremilast likely to work well enough for my type and extent of psoriasis or arthritis?
- Should I use the 5-day starter schedule, and what should I do if I get diarrhea or nausea?
- Does my kidney function mean I need the once-daily dose?
- Do any of my medicines, such as carbamazepine or phenytoin, interact with apremilast?
- How often should my weight and mood be checked?
- Is Otezla covered by my plan, and does a manufacturer program lower my cost?
Related guides
- Brand vs generic drug prices: what US pharmacies pay (NADAC)
- Generic Janumet: now in US pharmacies
- Generic vs brand name medicines: are they the same?
- Canadian online pharmacies: safety and cost for US buyers
- Prescription skin care medicine guide
Sources
- OTEZLA (apremilast) tablets and OTEZLA XR (apremilast) extended-release tablets, US prescribing information, Amgen Inc. (DailyMed setid f6b1f516-4972-4d82-bced-113e47b41cc5, version 38 published 11 September 2026): sections 1, 2, 3, 4, 5, 6.1, 7, 8, 12, 14 and 16.
- US Food and Drug Administration. Drugs@FDA via openFDA: NDA 205437, NDA 206088, NDA 210745 and ANDAs 211674, 211716, 211734, 211756, 211761, 211774, 211782, 211788, 211819, 211834, 211859, 211878, 211887, 211897, accessed 26 October 2026.
- US Food and Drug Administration. NDC directory via openFDA, generic name apremilast, accessed 26 October 2026.
- Centers for Medicare and Medicaid Services. National Average Drug Acquisition Cost (NADAC) 2026 dataset, Otezla rows as of 21 October 2026; search for "APREMILAST" returned no rows.
- Centers for Medicare and Medicaid Services. Medicare Drug Price Negotiation Program: Negotiated Prices for Initial Price Applicability Year 2027 (fact sheet).
- Amgen. Amgen Wins Patent Appeal on Otezla (apremilast). Press release, 19 April 2023.
- Amgen. 2024 Annual Report and Form 10-K: patent table and footnotes for Otezla.
- Glenmark Pharmaceuticals. Glenmark Pharmaceuticals receives ANDA approval for Apremilast Tablets, 10 mg, 20 mg and 30 mg. Press release, 17 October 2023.
- Papp K, et al. Apremilast in patients with moderate to severe plaque psoriasis: results of a phase III, randomized, controlled trial (ESTEEM 1). J Am Acad Dermatol 2015. PMID 26089047.
- Paul C, et al. Efficacy and safety of apremilast in patients with moderate-to-severe plaque psoriasis over 52 weeks (ESTEEM 2). Br J Dermatol 2015. PMID 26357944.
- US Food and Drug Administration. Personal Importation, accessed 26 October 2026.
This guide is for information and does not replace advice from a doctor or pharmacist who knows your medical history. Do not start, stop or change psoriasis or arthritis medicines without medical advice.
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