Help paying · Medicare negotiated price · pharmacy cost · cycle 2027
Pomalyst (pomalidomide): where help paying exists, what Medicare negotiated and what pharmacies pay
Medicare's negotiated price for a 30-day supply is $8,650 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 57 recruiting trials that name pomalidomide.
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 |
|---|---|---|---|---|---|---|
| 59572-0501-00 | POMALYST (POMALIDOMIDE) 1mg, 100 caps/Bottle | n/a | n/a | $435 | n/a | no NADAC price |
| 59572-0501-21 | POMALYST (POMALIDOMIDE) 1mg, 21 caps/Bottle | n/a | n/a | $435 | n/a | no NADAC price |
| 59572-0502-00 | POMALYST (POMALIDOMIDE) 2mg, 100 caps/Bottle | n/a | n/a | $435 | n/a | no NADAC price |
| 59572-0502-21 | POMALYST (POMALIDOMIDE) 2mg, 21 caps/Bottle | n/a | n/a | $435 | n/a | no NADAC price |
| 59572-0503-00 | POMALYST (POMALIDOMIDE) 3mg, 100 caps/Bottle | n/a | n/a | $435 | n/a | no NADAC price |
| 59572-0503-21 | POMALYST (POMALIDOMIDE) 3mg, 21 caps/Bottle | n/a | n/a | $435 | n/a | no NADAC price |
| 59572-0504-00 | POMALYST (POMALIDOMIDE) 4mg, 100 caps/Bottle | n/a | n/a | $435 | n/a | no NADAC price |
| 59572-0504-21 | POMALYST (POMALIDOMIDE) 4mg, 21 caps/Bottle | n/a | n/a | $435 | 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 |
|---|---|---|---|---|---|
| NDA204026 | Pomalyst (pomalidomide) 1mg, 100 Caps/bottle, Pomalyst (pomalidomide) 1mg, 21 Caps/bottle, Pomalyst (pomalidomide) 2mg, 100 Caps/bottle, Pomalyst (pomalidomide) 2mg, 21 Caps/bottle and 4 more | December 21, 2031 | November 14, 2027 | December 21, 2031 | patent 8828427 with its pediatric extension; 36 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 Pomalyst of $2.15 billion in 2024, across 98,648 claims and 14,325 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 | $2.15 billion | 98,648 | 14,325 | $21,797 |
| 2023 | $1.71 billion | 78,733 | 12,739 | $21,710 |
| 2022 | $1.74 billion | 86,195 | 12,682 | $20,232 |
| 2021 | $1.60 billion | 82,854 | 12,596 | $19,252 |
| 2020 | $1.45 billion | 79,081 | 12,067 | $18,384 |
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.
FDA safety program (REMS)
- PS-Pomalidomide (application NDA204026): listed as in force, with Elements to Assure Safe Use. Program dated February 26, 2025, last modified April 27, 2026. REMS@FDA program page. The application is also named in 1 other program.
A REMS is a safety program the FDA can require for a drug. Some restrict how it is prescribed or dispensed, for example through certified prescribers or pharmacies. This lists what the FDA's REMS@FDA files tie to the application; it does not say which prescribers or pharmacies take part, or whether a given patient needs the program.
Source: FDA REMS@FDA data files (rems-fda-files-2026-11-07-products-20a9945448dd), read November 7, 2026. REMS@FDA product file.
Rare-disease (orphan) designations
The FDA's orphan drug database lists 4 designations for pomalidomide, 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 |
|---|---|---|---|
| April 4, 2018 | Treatment of Kaposi sarcoma | Designated/Approved | Celgene Corporation |
| August 22, 2013 | Treatment of systemic sclerosis | Designated/Designation Withdrawn or Revoked | Celgene Corporation |
| September 21, 2010 | Treatment of persons with myeloproliferative neoplasm-associated myelofibrosis and anemia who are red blood cell tranfusion dependent. | Designated/Designation Withdrawn or Revoked | Celgene Corporation |
| January 15, 2003 | Treatment of multiple myeloma | Designated/Approved | Celgene Corporation |
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 3 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 |
|---|---|---|---|
| OH | 65 | $1,434,601 | Fee-for-service only |
| OR | 62 | $1,379,937 | All record types |
| IL | 81 | $1,339,887 | 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 (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. 23 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 Pomalyst dated since November 11, 2025, leaving out manufacturing (CMC) changes. 1 change in the window.
| Date | Class | Application | Submissions | FDA documents |
|---|---|---|---|---|
| April 27, 2026 | REMS | NDA204026 | 35 | FDA letter posted May 1, 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.
Safety notices
FDA enforcement report entries that name a package of Pomalyst 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-0768-2018 | 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 57 interventional trials that name pomalidomide and are recruiting, and 13 more not yet recruiting. By phase: Phase 3: 16, Phase 2: 15, PHASE1/PHASE2: 13, Phase 1: 9, Not applicable: 3, PHASE2/PHASE3: 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 |
|---|---|---|---|---|---|
| NCT05730036 | A Trial to Learn How Well Linvoseltamab Works Compared to the Combination of Elotuzumab, Pomalidomide and Dexamethasone for Adult Participants With Relapsed/Refractory Multiple MyelomaRelapsed Refractory Multiple Myeloma (RRMM) | Phase 3 | Regeneron Pharmaceuticals | November 6, 2026 | United States, Australia, Belgium and 7 more |
| NCT05137054 | A Study to Examine the Effects of Novel Therapy Linvoseltamab in Combination With Other Cancer Treatments for Adult Participants With Multiple Myeloma That is Resistant to Current Standard of Care TreatmentsMultiple Myeloma | Phase 1 | Regeneron Pharmaceuticals | November 5, 2026 | United States, France, Greece and 2 more |
| NCT07825064 | Cevostamab in Combination With Pomalidomide and Dexamethasone After BCMA- Targeting CAR T-Cell Therapy in Participants With Previously Treated Multiple MyelomaMultiple Myeloma | Phase 2 | Hoffmann-La Roche | November 5, 2026 | Germany |
| NCT06948084 | Testing the Investigational Medication Combination of Daratumumab and Teclistamab Compared to the Usual Treatment (Daratumumab, Pomalidomide, Dexamethasone or Daratumumab, Carfilzomib, Dexamethasone) for Patients With High-risk Multiple Myeloma Refractory or in First RelapseRecurrent Multiple Myeloma; Refractory Multiple Myeloma | Phase 2 | National Cancer Institute (NCI) | November 4, 2026 | United States |
| NCT07222761 | A Study to Compare Linvoseltamab Monotherapy and Linvoseltamab + Carfilzomib Combination Therapy With Standard-of-Care Combination Regimens in Adult Participants With Relapsed/Refractory Multiple Myeloma (RRMM)Relapsed and/or Refractory Multiple Myeloma (RRMM) | Phase 3 | Regeneron Pharmaceuticals | November 4, 2026 | United States, Australia, Brazil and 5 more |
| NCT06106945 | AZD0305 as Monotherapy or in Combination With Anticancer Agents in Participants With Multiple MyelomaMultiple Myeloma | Phase 1 / Phase 2 | AstraZeneca | October 30, 2026 | United States, Australia, Brazil and 7 more |
| NCT05519085 | A Study to Evaluate Mezigdomide, Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)Relapsed or Refractory Multiple Myeloma | Phase 3 | Celgene | October 30, 2026 | United States, Argentina, Australia and 7 more |
| NCT06615479 | A Study to Compare the Efficacy and Safety of BMS-986393 Versus Standard Regimens in Adult Participants With Relapsed or Refractory and Lenalidomide-exposed Multiple Myeloma (QUINTESSENTIAL-2)Relapsed or Refractory Multiple Myeloma (RRMM) | Phase 3 | Juno Therapeutics, Inc., a Bristol-Myers Squibb Company | October 29, 2026 | United States, Argentina, Australia and 7 more |
| NCT06953960 | A Study to Assess Adverse Events and Change in Disease Activity of Oral Surzetoclax Alone or in Combination With Subcutaneous and/or Oral Antimyeloma Agents in Adult Participants With Multiple Myeloma (MM)Multiple Myeloma | Phase 1 / Phase 2 | AbbVie | October 27, 2026 | United States, Australia, Belgium and 7 more |
| NCT04973605 | A Phase 1b/2 Study of Sonrotoclax (BGB-11417) as Monotherapy and in Various Combinations With Dexamethasone Plus Carfilzomib, Dexamethasone Plus Daratumumab, and Dexamethasone Plus Pomalidomide in Multiple MyelomaRelapsed/Refractory Multiple Myeloma | Phase 1 / Phase 2 | BeOne Medicines | October 26, 2026 | United States, Australia, 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 Pomalyst?
The CMS file publishes $8,650 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 Pomalyst?
No program in our finder lists this drug yet.
When could a generic version of Pomalyst arrive?
For Pomalyst, the FDA's Orange Book (edition September 2026) lists these latest patent or exclusivity expiry dates by application: NDA204026, December 21, 2031. 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 Pomalyst?
ClinicalTrials.gov lists 57 recruiting interventional trials that name pomalidomide (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 Pomalyst?
CMS's Medicare Part D spending dataset reports gross spending on Pomalyst of $2.15 billion in 2024, across 98,648 claims and 14,325 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/pomalyst.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.