Help paying · Medicare negotiated price · pharmacy cost · cycle 2027
Otezla (apremilast): where help paying exists, what Medicare negotiated and what pharmacies pay
1 assistance program lists apremilast, each with its income ceiling and when we read it. Medicare's negotiated price for a 30-day supply is $1,650 on January 1, 2027. 1 non-manufacturing label change is dated in the last 12 months in the FDA's file. The FDA's enforcement reports name this drug's packages in 1 recall entry. ClinicalTrials.gov lists 10 recruiting trials that name apremilast.
Every package we can price
Per-unit prices (per each unit, as the files state). "Scheduled" is a price the CMS file already dates for the future.
| NDC | Product | Unit | Negotiated now | Scheduled | NADAC | Share |
|---|---|---|---|---|---|---|
| 55513-0137-28 | (name not listed) | n/a | n/a | $28.57 | n/a | no NADAC price |
| 55513-0137-50 | (name not listed) | n/a | n/a | $28.57 | n/a | no NADAC price |
| 55513-0137-60 | OTEZLA (apremilast) | EA | n/a | $28.57 | $90.59 | - |
| 55513-0369-55 | OTEZLA (apremilast) | EA | n/a | $31.09 | $98.76 | - |
| 55513-0497-51 | (name not listed) | n/a | n/a | $28.98 | n/a | no NADAC price |
| 55513-0497-60 | OTEZLA (apremilast) | EA | n/a | $28.98 | $89.95 | - |
| 55513-0508-55 | OTEZLA (apremilast) | n/a | n/a | $31.61 | n/a | no NADAC price |
| 55513-0516-41 | OTEZLA (apremilast) | n/a | n/a | $41.70 | n/a | no NADAC price |
| 55513-0518-04 | (name not listed) | n/a | n/a | $31.61 | n/a | no NADAC price |
| 55513-0519-30 | OTEZLA (apremilast) | EA | n/a | $57.14 | $181 | - |
| 59572-0630-27 | OTEZLA (APREMILAST) 10/20/30mg, BLISTER PACK KIT | n/a | n/a | $31.09 | n/a | no NADAC price |
| 59572-0631-06 | OTEZLA (APREMILAST) 30mg, 60 tabs/Bottle | n/a | n/a | $28.57 | n/a | no NADAC price |
| 59572-0631-28 | OTEZLA 30 MG TABLET | n/a | n/a | $28.57 | n/a | no NADAC price |
| 59572-0632-55 | OTEZLA (APREMILAST)10/20/30 MG, 28 DAY TITRATION STARTER PACK | n/a | n/a | $31.09 | n/a | no NADAC price |
When could a generic arrive
Each date below is an upper bound from listed patent and exclusivity dates, not a forecast of when a generic will launch. Basis: latest of all listed patent and exclusivity expiries in this Orange Book edition; an upper bound from listed dates only, not a forecast of launch (litigation, settlements, delisting, tentative approvals and 180-day status are not modelled).
| Application | Product | Latest listed patent expiry | Latest listed exclusivity expiry | Latest of the two | Set by |
|---|---|---|---|---|---|
| NDA205437 | Otezla (apremilast) | November 29, 2034 | October 25, 2027 | November 29, 2034 | patent 10092541 with its pediatric extension; 42 dated entries listed |
| NDA210745 | Otezla (apremilast) | May 27, 2042 | January 20, 2027 | May 27, 2042 | patent 11752129; 9 dated entries listed |
Source: FDA Orange Book data files, edition September 2026, read November 7, 2026; patent listings are as submitted by applicants and not verified by FDA. FDA data file.
Medicare Part D spending
CMS's Medicare Part D spending dataset reports gross spending on Otezla of $1.05 billion in 2024, across 213,396 claims and 31,045 beneficiaries. CMS's dataset states spending is gross drug cost and does not reflect manufacturers' rebates or other price concessions. Spending is the total paid by Medicare, plans and beneficiaries for the drug's claims, not what a patient pays.
| Year | Gross spending | Claims | Beneficiaries | Average spending per claim |
|---|---|---|---|---|
| 2024 | $1.05 billion | 213,396 | 31,045 | $4,897 |
| 2023 | $876.96 million | 178,462 | 26,816 | $4,914 |
| 2022 | $710.07 million | 151,971 | 24,076 | $4,672 |
| 2021 | $582.34 million | 135,689 | 22,313 | $4,292 |
| 2020 | $488.49 million | 123,934 | 20,131 | $3,942 |
Source: CMS Medicare Part D spending by drug (data-year-2024, modified 2026-06-25), read November 7, 2026. CMS dataset page. All manufacturers combined; the figures are a drug-level aggregate of claims and say nothing about a formulary or coverage.
Rare-disease (orphan) designations
The FDA's orphan drug database lists 3 designations for apremilast, 2 with an approval recorded. A designation is not an approval and not a statement that the drug treats the condition; the status column is the database's own.
| Designated | Designated use | Status | Sponsor |
|---|---|---|---|
| January 17, 2018 | Treatment of pediatric patients with ulcerative colitis | Designated | Amgen Inc. |
| January 17, 2013 | Treatment of Behcet's disease | Designated/Approved | Amgen Inc. |
| January 17, 2013 | Treatment of Behcet's disease | Designated/Approved | Amgen Inc. |
Source: FDA Orphan Drug Designations and Approvals database, read November 7, 2026. FDA orphan drug search.
Medicaid use by state
CMS's State Drug Utilization Data records, for 2025, how many prescriptions each state's Medicaid program paid for under this drug's packages and what it reimbursed. The 7 states with the largest reimbursement are shown. Reimbursement is before the rebates manufacturers pay states, so it is not a net cost and not a price a patient pays.
| State | Medicaid-paid prescriptions | Medicaid reimbursed | Covers |
|---|---|---|---|
| CA | 211 | $1,109,731 | All record types |
| UT | 89 | $488,774 | Fee-for-service only |
| KY | 142 | $477,620 | Fee-for-service only |
| NC | 88 | $450,450 | All record types |
| WA | 58 | $305,500 | All record types |
| WI | 72 | $299,668 | All record types |
| NY | 54 | $297,261 | All record types |
Where the publisher suppresses small managed-care cells, a state's figure covers fee-for-service claims only and understates use (2 state and package figures are marked that way here). A state missing from the table means its figures were suppressed or not reported, not zero use. 68 older-year figures are held and left out of the table.
Source: CMS State Drug Utilization Data (State Drug Utilization Data 2025, modified 2026-07-13T15:28:32Z), read November 7, 2026. CMS dataset page. State-reported data compiled by CMS; aggregate by state and package, no provider or patient data.
Where help paying exists
Programs in our finder that list apremilast. Each shows its income ceiling, when we read it and whether we checked it against the program's own document. Eligibility is decided by the program, not by us.
- Amgen Safety Net Foundation manufacturer
Income at or below $47,880 for one person (300% FPL), and no insurance coverage
Limit read October 19, 2026.
Check where your income sits against each ceiling: open the assistance finder. See what has changed and when we last verified each program on the program status board.
Label changes
FDA actions on the applications behind Otezla dated since November 11, 2025, leaving out manufacturing (CMC) changes. 1 change in the window.
| Date | Class | Application | Submissions | FDA documents |
|---|---|---|---|---|
| December 23, 2025 | Labeling | NDA205437 | 16 | Label (PDF) posted December 30, 2025FDA letter posted December 31, 2025 |
Source: FDA Drugs@FDA data file, read November 7, 2026. Dates are the FDA action dates; the documents are on FDA's own site. FDA data file. All recent changes across these drugs: label changes feed.
Safety notices
FDA enforcement report entries that name a package of Otezla by its NDC: 1 entry, newest first. FDA assigns each a class by health risk: Class I is the most serious and Class III the least. An entry records what the recalling firm reported and FDA classified; it is not advice about any package you hold.
| Reported | Class | Status | Recalling firm | Reason (shortened) | Packages named |
|---|---|---|---|---|---|
| May 16, 2018D-0740-2018 | Class II | Terminated | Kroger Specialty Pharmacy, Inc. | Lack of Processing Controls. | 1 |
Source: openFDA drug enforcement reports, file read November 7, 2026. openFDA data file. All recent recalls across these drugs: drug recalls feed.
Clinical trials recruiting
ClinicalTrials.gov lists 10 interventional trials that name apremilast and are recruiting, and 7 more not yet recruiting. By phase: Phase 3: 5, Phase 2: 3, Phase 1: 1, Early phase 1: 1. The 10 most recently updated are below. A listing is not an offer of free drug and not medical advice. Whether a trial fits is decided by the study team and your own clinician.
| Trial | Title and conditions | Phase | Lead sponsor | Last updated | Countries |
|---|---|---|---|---|---|
| NCT02735707 | Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired PneumoniaRespiratory Tract Diseases; Influenza (Pandemic); Influenza | Phase 3 | UMC Utrecht | November 4, 2026 | United States, Australia, Belgium and 7 more |
| NCT05767047 | A Study of Apremilast in Children With Oral Ulcers Associated With Behçet's Disease or Juvenile Psoriatic ArthritisBehçet's Disease; Juvenile Psoriatic Arthritis | Phase 3 | Amgen | November 4, 2026 | Greece, Israel, Spain and 1 more |
| NCT07029529 | Phase 2 Study of Apremilast in Women and Men With Alcohol Use DisorderAlcohol Use Disorder | Phase 2 | Yale University | October 30, 2026 | United States |
| NCT04804553 | Apremilast Pediatric Study in Children With Active Juvenile Psoriatic ArthritisActive Juvenile Psoriatic Arthritis | Phase 3 | Amgen | October 20, 2026 | Belgium, France, Germany and 7 more |
| NCT05703685 | [18F]PF-06445974 to Image PDE4B in Major Depressive Disorder Using PETDepression | Phase 1 | National Institute of Mental Health (NIMH) | October 1, 2026 | United States |
| NCT04528082 | Apremilast Pediatric Study in Children With Active Oral Ulcers Associated With Behçet's DiseaseBehçet Disease | Phase 3 | Amgen | July 24, 2026 | France, Greece, Israel and 5 more |
| NCT07325266 | Human Laboratory Study of Apremilast for Alcohol Use DisorderAlcohol Use Disorder; Alcohol Misuse | Phase 2 | National Institute on Alcohol Abuse and Alcoholism (NIAAA) | May 1, 2026 | United States |
| NCT04227314 | Randomized Double Blind Controlled Trial Comparing the Safety and Efficacy of Apremilast Versus Placebo in Severe Forms of Recurrent Aphthous StomatitisRecurrent Aphtous Stomatitis | Phase 3 | University Hospital, Rouen | February 17, 2026 | France |
| NCT07337434 | To Check Comparison of Apremilast and Methotrexate Efficacy in Patients With Moderate to Severe Plaque Psoriasis Presented to Tertiary Care HospitalChronic Plaque Psoriasis | Early phase 1 | Syeda Sana Zaman | January 13, 2026 | Pakistan |
| NCT06509984 | A 20-Week Study Assessing the Efficacy of Apremilast in Patients with EB Simplex GeneralizedEpidermolysis Bullosa Simplex; Genodermatosis | Phase 2 | Centre Hospitalier Universitaire de Nice | February 24, 2025 | France |
Source: ClinicalTrials.gov, registry data processed November 6, 2026, summarized and trimmed by OmniRx. Search on ClinicalTrials.gov.
Questions
What is the Medicare negotiated price of Otezla?
The CMS file publishes $1,650 from January 1, 2027. This is a price CMS agreed with the manufacturer for Medicare Part D, not what a person pays at the counter.
How does the negotiated price compare with what pharmacies pay?
The two CMS files do not give a comparable per-unit price for this drug.
Is there help paying for Otezla?
1 assistance program lists it in our finder. Eligibility depends on income, coverage and the program's current rules; each program's own page decides.
When could a generic version of Otezla arrive?
For Otezla, the FDA's Orange Book (edition September 2026) lists these latest patent or exclusivity expiry dates by application: NDA205437, November 29, 2034; NDA210745, May 27, 2042. Each date is an upper bound from listed patent and exclusivity dates, not a forecast of when a generic will launch. Basis: latest of all listed patent and exclusivity expiries in this Orange Book edition; an upper bound from listed dates only, not a forecast of launch (litigation, settlements, delisting, tentative approvals and 180-day status are not modelled).
Can I join a clinical trial for Otezla?
ClinicalTrials.gov lists 10 recruiting interventional trials that name apremilast (registry data processed November 6, 2026). A listing is not an offer of free drug and not medical advice. Whether a trial fits is decided by the study team and your own clinician.
How much does Medicare Part D spend on Otezla?
CMS's Medicare Part D spending dataset reports gross spending on Otezla of $1.05 billion in 2024, across 213,396 claims and 31,045 beneficiaries. CMS's dataset states spending is gross drug cost and does not reflect manufacturers' rebates or other price concessions. Spending is the total paid by Medicare, plans and beneficiaries for the drug's claims, not what a patient pays.
For developers: this drug as data
One call returns price, generic-entry upper bound, label history, recalls, trials, assistance, and where facts exist the FDA safety program (REMS), DEA schedule, orphan designations, safety notices and Medicaid use by state, each with receipts.
Example file: https://omnirx.org/api/v1/dossier/otezla.json
The licence page sets out what a data licence covers, and the API page documents these files.
Evaluation files with receipts; contract may change; not clinical advice.
Sources and terms. CMS Medicare Drug Price Negotiation Program data file (read November 6, 2026; the CMS page states no licence or restriction); CMS NADAC from data.medicaid.gov under the labels in the OmniRx licence ledger; program details read from each program's own pages; CMS Medicare Part D spending by drug; FDA Drugs@FDA and Orange Book data files; openFDA drug enforcement reports; ClinicalTrials.gov registry data. Figures are stored with their sources in the OmniRx library (edition 2026-11). Free to cite with attribution. Not medical, legal or financial advice. Report an error through the contact page. Licence the data.