Help paying · Medicare negotiated price · pharmacy cost · cycle 2028
Lenvima (lenvatinib): where help paying exists, where Medicare's negotiation stands and what pharmacies pay
CMS has selected Lenvima 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. 1 non-manufacturing label change is dated in the last 12 months in the FDA's file. ClinicalTrials.gov lists 146 recruiting trials that name lenvatinib.
Every package CMS lists
Packages the CMS file lists for Lenvima, with NADAC per unit where the benchmark has one (per unit, as the files state).
| NDC | Unit | CMS price status | NADAC |
|---|---|---|---|
| 62856-0704-05 | n/a | Selected; price takes effect January 1, 2028, not yet published | n/a |
| 62856-0704-30 | n/a | Selected; price takes effect January 1, 2028, not yet published | n/a |
| 62856-0708-05 | n/a | Selected; price takes effect January 1, 2028, not yet published | n/a |
| 62856-0708-30 | n/a | Selected; price takes effect January 1, 2028, not yet published | n/a |
| 62856-0710-05 | n/a | Selected; price takes effect January 1, 2028, not yet published | n/a |
| 62856-0710-30 | n/a | Selected; price takes effect January 1, 2028, not yet published | n/a |
| 62856-0712-05 | n/a | Selected; price takes effect January 1, 2028, not yet published | n/a |
| 62856-0712-30 | n/a | Selected; price takes effect January 1, 2028, not yet published | n/a |
| 62856-0714-05 | n/a | Selected; price takes effect January 1, 2028, not yet published | n/a |
| 62856-0714-30 | n/a | Selected; price takes effect January 1, 2028, not yet published | n/a |
| 62856-0718-05 | n/a | Selected; price takes effect January 1, 2028, not yet published | n/a |
| 62856-0718-30 | n/a | Selected; price takes effect January 1, 2028, not yet published | n/a |
| 62856-0720-05 | n/a | Selected; price takes effect January 1, 2028, not yet published | n/a |
| 62856-0720-30 | n/a | Selected; price takes effect January 1, 2028, not yet published | n/a |
| 62856-0724-05 | n/a | Selected; price takes effect January 1, 2028, not yet published | n/a |
| 62856-0724-30 | 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 |
|---|---|---|---|---|---|
| NDA206947 | Lenvima 10mg, Lenvima 12mg, Lenvima 14mg, Lenvima 18mg and 4 more | November 15, 2038 | October 3, 2027 | November 15, 2038 | patent 12226409 with its pediatric extension; 48 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 Lenvima of $875.64 million in 2024, across 37,139 claims and 8,450 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 | $875.64 million | 37,139 | 8,450 | $23,577 |
| 2023 | $778.83 million | 32,513 | 7,904 | $23,955 |
| 2022 | $625.98 million | 28,321 | 7,066 | $22,103 |
| 2021 | $452.13 million | 21,961 | 5,725 | $20,588 |
| 2020 | $367.77 million | 19,016 | 4,883 | $19,340 |
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 5 designations for lenvatinib, 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 |
|---|---|---|---|
| November 14, 2024 | treatment of esophageal cancer | Designated | Eisai Inc. |
| November 14, 2024 | treatment of gastric cancer, including gastroesophageal junction cancer | Designated | Eisai Inc. |
| March 27, 2014 | Treatment of hepatocellular carcinoma | Designated/Approved | Eisai Inc. |
| March 26, 2014 | Treatment of stage IIB to Stage IV melanoma | Designated | Eisai, Inc. |
| December 27, 2012 | Treatment of follicullar, medullary, anaplastic, and metastatic or locally advanced papillary thyroid cancer | Designated/Approved | Eisai, 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 5 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 | 97 | $2,306,660 | Fee-for-service only |
| NC | 66 | $1,610,369 | Fee-for-service only |
| PA | 54 | $1,303,569 | Fee-for-service only |
| MI | 49 | $1,220,894 | All record types |
| NM | 58 | $1,106,610 | All record types |
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. 28 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 Lenvima dated since November 11, 2025, leaving out manufacturing (CMC) changes. 1 change in the window.
| Date | Class | Application | Submissions | FDA documents |
|---|---|---|---|---|
| September 24, 2026 | Efficacy | NDA206947 | 35 | Label (PDF) posted September 28, 2026FDA letter posted September 28, 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 146 interventional trials that name lenvatinib and are recruiting, and 82 more not yet recruiting. By phase: Phase 2: 90, Phase 3: 17, PHASE1/PHASE2: 15, Not applicable: 10, Phase 1: 7, Phase 4: 4, Early phase 1: 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 |
|---|---|---|---|---|---|
| NCT06253494 | Pembrolizumab, Lenvatinib and IL-15 Superagonist N-803 in Combination With HER2 Targeting Autologous Dendritic Cell (AdHER2DC) Vaccine in Participants With Advanced or Metastatic Endometrial CancerEndometrial Cancer; Cancer of Endometrium; Carcinoma of Endometrium | Phase 1 / Phase 2 | National Cancer Institute (NCI) | November 5, 2026 | United States |
| NCT07149090 | Lenvatinib in Combination With Nivolumab Plus Chemotherapy in Metastatic Gastric Cancer Patients With Malignant AscitesSTOMACH NEOPLASM; Gastric Cancer; Gastric Cancer Adenocarcinoma Metastatic | Phase 1 / Phase 2 | Asan Medical Center | November 4, 2026 | South Korea |
| NCT07909265 | Prospective Study of Cadonilimab With Lenvatinib in Renal Cell CarcinomaRenal Cell Carcinoma (Kidney Cancer); Clear Cell Renal Cell Carcinoma | Phase 2 | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | November 2, 2026 | China |
| NCT03486873 | Long-term Safety and Efficacy Extension Study for Participants With Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab (MK-3475) Study (MK-3475-587/KEYNOTE-587)Solid Tumors; Hematologic Malignancies | Phase 3 | Merck Sharp & Dohme LLC | October 29, 2026 | United States, Argentina, Australia and 7 more |
| NCT07487662 | TACE or Ablation Combined With Sintilimab and Ipilimumab N01 as Neoadjuvant Therapy for Resectable Hepatocellular Carcinoma With Intermediate-High Recurrence RiskHepato Cellular Carcinoma (HCC) | Phase 2 | Sun Yat-sen University | October 27, 2026 | China |
| NCT05327686 | Testing the Addition of Stereotactic Radiation Therapy With Immune Therapy for the Treatment of Patients With Unresectable or Metastatic Renal Cell Cancer, SAMURAI TrialMetastatic Renal Cell Carcinoma; Stage III Renal Cell Cancer AJCC v8; Stage IV Renal Cell Cancer AJCC v8 | Phase 2 | NRG Oncology | October 23, 2026 | United States, Australia, Canada and 1 more |
| NCT07405164 | Extension Study for Participants in Studies That Include Belzutifan (MK-6482-043/LITESPARK-043)Von Hippel-Lindau Disease; Malignant Neoplasms | Phase 3 | Merck Sharp & Dohme LLC | October 21, 2026 | United States, Australia, Belgium and 7 more |
| NCT04977453 | GI-101/GI-101A as a Single Agent or in Combination With Pembrolizumab or Lenvatinib in Advanced Solid TumorsAdvanced Solid Tumor; Metastatic Solid Tumor; Cervical Cancer | Phase 1 / Phase 2 | GI Innovation, Inc. | October 19, 2026 | United States, South Korea |
| NCT07159204 | Polymeric Micellar Paclitaxel-Based Combination Therapy for Advanced Biliary Tract CancerBiliary Tract Cancer (BTC) | Phase 2 | Peking Union Medical College Hospital | October 15, 2026 | China |
| NCT07874321 | MRG003 Added to Ongoing Treatment After Progression in EGFR-Positive Advanced Thyroid CancerThyroid Cancer; Tumor; Advanced Thyroid Carcinoma | Phase 2 | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | October 14, 2026 | China |
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 Lenvima?
CMS has selected Lenvima 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 Lenvima?
No program in our finder lists this drug yet.
When could a generic version of Lenvima arrive?
For Lenvima, the FDA's Orange Book (edition September 2026) lists these latest patent or exclusivity expiry dates by application: NDA206947, November 15, 2038. 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 Lenvima?
ClinicalTrials.gov lists 146 recruiting interventional trials that name lenvatinib (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 Lenvima?
CMS's Medicare Part D spending dataset reports gross spending on Lenvima of $875.64 million in 2024, across 37,139 claims and 8,450 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/lenvima.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.