Help paying · Medicare negotiated price · pharmacy cost · cycle 2028
Erleada (apalutamide): where help paying exists, where Medicare's negotiation stands and what pharmacies pay
CMS has selected Erleada for the 2028 negotiation cycle. The CMS file we read (November 6, 2026) lists its negotiated price as taking effect January 1, 2028 and holds no price for it yet, so this page shows no negotiated price. 2 non-manufacturing label changes are dated in the last 12 months in the FDA's file. ClinicalTrials.gov lists 39 recruiting trials that name apalutamide.
Every package CMS lists
Packages the CMS file lists for Erleada, with NADAC per unit where the benchmark has one (per unit, as the files state).
| NDC | Unit | CMS price status | NADAC |
|---|---|---|---|
| 59676-0600-12 | n/a | Selected; price takes effect January 1, 2028, not yet published | n/a |
| 59676-0604-30 | n/a | Selected; price takes effect January 1, 2028, not yet published | n/a |
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 |
|---|---|---|---|---|---|
| NDA210951 | Erleada 240mg, Erleada 60mg Tab | January 14, 2041 | none listed | January 14, 2041 | patent 11723898; 28 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 Erleada of $1.39 billion in 2024, across 95,580 claims and 13,253 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 | $1.39 billion | 95,580 | 13,253 | $14,504 |
| 2023 | $1.06 billion | 71,302 | 11,077 | $14,835 |
| 2022 | $877.67 million | 62,197 | 9,266 | $14,111 |
| 2021 | $734.68 million | 55,051 | 8,497 | $13,345 |
| 2020 | $469.31 million | 36,947 | 5,808 | $12,702 |
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.
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 4 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 |
|---|---|---|---|
| NY | 229 | $3,502,931 | Fee-for-service only |
| OH | 83 | $1,190,445 | Fee-for-service only |
| NC | 57 | $872,480 | All record types |
| IL | 48 | $702,034 | Fee-for-service only |
Where the publisher suppresses small managed-care cells, a state's figure covers fee-for-service claims only and understates use (3 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. 21 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
No program in our finder currently lists this drug as open to new patients.
Label changes
FDA actions on the applications behind Erleada dated since November 11, 2025, leaving out manufacturing (CMC) changes. 2 changes in the window.
| Date | Class | Application | Submissions | FDA documents |
|---|---|---|---|---|
| June 29, 2026 | Labeling | NDA210951 | 24 | Label (PDF) posted July 6, 2026FDA letter posted July 2, 2026 |
| March 5, 2026 | Labeling | NDA210951 | 21 | Label (PDF) posted March 12, 2026FDA letter posted March 9, 2026 |
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.
Clinical trials recruiting
ClinicalTrials.gov lists 39 interventional trials that name apalutamide and are recruiting, and 7 more not yet recruiting. By phase: Phase 2: 14, Phase 3: 14, Phase 1: 5, Not applicable: 3, PHASE1/PHASE2: 3. 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 |
|---|---|---|---|---|---|
| NCT07745361 | Study of Oral MRT-2359 With Apalutamide in Prostate CancerCastration-Resistant Prostate Cancer (CRPC); Castration-Resistant Prostate Cancer; Prostate Cancer | Phase 2 | Monte Rosa Therapeutics, Inc | November 5, 2026 | United States |
| NCT07751133 | Evaluating Hormone Therapy to Achieve Optimal Doses in Metastatic Prostate CancerProstate Cancer; mHSPC; mCRPC | Phase 3 | University College, London | November 4, 2026 | United Kingdom |
| NCT05818683 | A Study of Pasritamig (JNJ-78278343) in Combination With Other Agents for Metastatic Prostate CancerMetastatic Castration-resistant Prostate Neoplasms; Metastatic Hormone-sensitive Prostate Cancer | Phase 1 | Janssen Research & Development, LLC | November 3, 2026 | United States, Australia, Spain |
| NCT06095089 | A Study of JNJ-87189401 Combined With JNJ-78278343 for Advanced Prostate CancerProstatic Neoplasms | Phase 1 | Janssen Research & Development, LLC | November 3, 2026 | United States, Australia, China and 2 more |
| NCT06931340 | Testing the Addition of Docetaxel (Chemotherapy) to the Usual Treatment (Hormonal Therapy and Apalutamide) for Metastatic Prostate Cancer, ASPIRE TrialCastration-Sensitive Prostate Carcinoma; Metastatic Prostate Adenocarcinoma; Stage IVB Prostate Cancer AJCC v8 | Phase 3 | Alliance for Clinical Trials in Oncology | November 3, 2026 | United States |
| NCT07611110 | AZD2265 Compared With Standard of Care in PSMA-positive Metastatic Castration-resistant Prostate Cancer (VECTRA-01)Metastatic Castration-resistant Prostate Cancer | Phase 3 | AstraZeneca | October 19, 2026 | United States, Australia, Austria and 7 more |
| NCT07783282 | A Study to Learn How Enzalutamide, Apalutamide and Bicalutamide Affect the Way Fezolinetant is Processed in Men With Prostate CancerProstate Cancer | Phase 1 | Astellas Pharma Global Development, Inc. | October 16, 2026 | Bulgaria |
| NCT05534646 | Study of AR Suppression With Carotuximab in Metastatic, Castration-Resistant Prostate CancCastration-resistant Prostate Cancer | Phase 2 | Edwin Posadas, MD | October 5, 2026 | United States |
| NCT05647564 | PET/CT Characterization of Treatment ResistanceProstate Cancer | Not applicable | University of Wisconsin, Madison | October 1, 2026 | United States |
| NCT07002320 | Investigating SX-682 in Combination With Apalutamide in Metastatic Castration-resistant Prostate CancerMetastatic Castrate-Resistant Prostate Cancer (mCRPC) | Phase 1 / Phase 2 | Institute of Cancer Research, United Kingdom | September 8, 2026 | Switzerland, United Kingdom |
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 Erleada?
CMS has selected Erleada for the 2028 negotiation cycle. The CMS file we read (November 6, 2026) lists its negotiated price as taking effect January 1, 2028 and holds no price for it yet, so this page shows no negotiated price. When CMS publishes a price it will be a Medicare Part D price agreed with the manufacturer, not what a person pays at the counter.
How does the negotiated price compare with what pharmacies pay?
No negotiated price is published yet, so there is nothing to compare with the pharmacy acquisition benchmark.
Is there help paying for Erleada?
No program in our finder lists this drug yet.
When could a generic version of Erleada arrive?
For Erleada, the FDA's Orange Book (edition September 2026) lists these latest patent or exclusivity expiry dates by application: NDA210951, January 14, 2041. 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 Erleada?
ClinicalTrials.gov lists 39 recruiting interventional trials that name apalutamide (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 Erleada?
CMS's Medicare Part D spending dataset reports gross spending on Erleada of $1.39 billion in 2024, across 95,580 claims and 13,253 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/erleada.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; 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.