Help paying · Medicare negotiated price · pharmacy cost · cycle 2027
Xtandi (enzalutamide): where help paying exists, what Medicare negotiated and what pharmacies pay
Medicare's negotiated price for a 30-day supply is $7,004 on January 1, 2027. 4 non-manufacturing label changes are 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 81 recruiting trials that name enzalutamide.
Every package we can price
Per-unit prices (per 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 |
|---|---|---|---|---|---|---|
| 00469-0125-99 | XTANDI 40MG CAPSULE 120/BOTTLE | n/a | n/a | $61.92 | n/a | no NADAC price |
| 00469-0625-99 | XTANDI 40MG TABLETS 120/BOTTLE | n/a | n/a | $61.93 | n/a | no NADAC price |
| 00469-0725-60 | XTANDI 80MG TABLETS 60/BOTTLE | n/a | n/a | $124 | 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 |
|---|---|---|---|---|---|
| NDA203415 | Xtandi 40mg Capsule 120/bottle | February 23, 2037 | November 17, 2026 | February 23, 2037 | patent 12161628; 5 dated entries listed |
| NDA213674 | Xtandi 40mg Tablets 120/bottle, Xtandi 80mg Tablets 60/bottle | February 23, 2037 | November 17, 2026 | February 23, 2037 | patent 12161628; 15 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 Xtandi of $3.40 billion in 2024, across 255,669 claims and 35,367 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 | $3.40 billion | 255,669 | 35,367 | $13,301 |
| 2023 | $2.60 billion | 191,657 | 28,658 | $13,574 |
| 2022 | $2.44 billion | 189,085 | 27,803 | $12,887 |
| 2021 | $2.41 billion | 198,288 | 30,007 | $12,160 |
| 2020 | $1.97 billion | 167,667 | 26,490 | $11,741 |
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 9 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 |
|---|---|---|---|
| KY | 182 | $2,459,498 | Fee-for-service only |
| MN | 86 | $1,064,559 | All record types |
| WA | 76 | $957,264 | All record types |
| AL | 76 | $934,186 | All record types |
| OR | 60 | $889,216 | All record types |
| HI | 62 | $834,146 | All record types |
| MA | 61 | $817,158 | Fee-for-service only |
| AZ | 72 | $815,677 | All record types |
| MD | 69 | $758,985 | 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. 54 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 Xtandi dated since November 11, 2025, leaving out manufacturing (CMC) changes. 4 changes in the window.
| Date | Class | Application | Submissions | FDA documents |
|---|---|---|---|---|
| July 24, 2026 | Efficacy | NDA203415 | 26 | Label (PDF) posted July 27, 2026FDA letter posted July 28, 2026 |
| July 24, 2026 | Efficacy | NDA213674 | 16 | Label (PDF) posted July 27, 2026FDA letter posted July 28, 2026 |
| December 11, 2025 | Labeling | NDA203415 | 25 | Label (PDF) posted December 18, 2025FDA letter posted December 12, 2025 |
| December 11, 2025 | Labeling | NDA213674 | 15 | Label (PDF) posted December 18, 2025FDA letter posted December 12, 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 Xtandi 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-0769-2018 | 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 81 interventional trials that name enzalutamide and are recruiting, and 16 more not yet recruiting. By phase: Phase 2: 28, Phase 3: 23, Phase 1: 15, PHASE1/PHASE2: 13, Not applicable: 2. 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 |
|---|---|---|---|---|---|
| NCT07287150 | A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate CancerMetastatic Castration-Resistant Prostate Cancer | Phase 2 | Hoffmann-La Roche | November 6, 2026 | United States, Australia, Brazil and 7 more |
| NCT03899155 | Pan Tumor Rollover StudyCancer | Phase 2 | Bristol-Myers Squibb | November 6, 2026 | United States, Argentina, Australia and 7 more |
| NCT06136624 | Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003)Prostate Cancer Metastatic | Phase 3 | Merck Sharp & Dohme LLC | November 5, 2026 | United States, Argentina, Australia and 7 more |
| 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 |
| NCT07723248 | A Study to Learn About the Investigational Drug Rinzimetostat (ORIC-944) in Patients With mCRPC Who Were Previously Treated With Abiraterone Acetate (Himalayas-1)Metastatic Castration Resistant Prostate Cancer | Phase 3 | ORIC Pharmaceuticals | November 3, 2026 | United States, Puerto Rico |
| 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 |
| NCT06632977 | Targeted Treatment for Metastatic Prostate Cancer, The PREDICT TrialCastration-Resistant Prostate Carcinoma; Stage IVB Prostate Cancer AJCC v8 | Phase 2 | Alliance for Clinical Trials in Oncology | November 3, 2026 | United States |
| NCT05873192 | Presurgical Phase II Study of Talazoparib in Combination With Enzalutamide in Prostate CancerProstate Cancer | Phase 2 | M.D. Anderson Cancer Center | November 2, 2026 | United States |
| NCT06499870 | Relugolix and Enzalutamide in Combination With Radiation Therapy for the Treatment of Very High Risk Prostate Cancer, OPTIMAL TrialProstate Adenocarcinoma | Phase 2 | Sean Sachdev | October 30, 2026 | United States |
| NCT06629779 | A Study to Learn How PF-06821497 (Mevrometostat) Works in Men With Metastatic Castration-resistant Prostate Cancer.Metastatic Castration-Resistant Prostate Cancer | Phase 3 | Pfizer | October 30, 2026 | United States, Argentina, Brazil and 7 more |
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 Xtandi?
The CMS file publishes $7,004 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 Xtandi?
No program in our finder lists this drug yet.
When could a generic version of Xtandi arrive?
For Xtandi, the FDA's Orange Book (edition September 2026) lists these latest patent or exclusivity expiry dates by application: NDA203415, February 23, 2037; NDA213674, February 23, 2037. 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 Xtandi?
ClinicalTrials.gov lists 81 recruiting interventional trials that name enzalutamide (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 Xtandi?
CMS's Medicare Part D spending dataset reports gross spending on Xtandi of $3.40 billion in 2024, across 255,669 claims and 35,367 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/xtandi.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.