Help paying · Medicare negotiated price · pharmacy cost · cycle 2027
Janumet (metformin): where help paying exists, what Medicare negotiated and what pharmacies pay
5 assistance programs list metformin, each with its income ceiling and when we read it. Medicare's negotiated price for a 30-day supply is $80.00 on January 1, 2027. 2 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 4 recruiting trials that name metformin.
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 |
|---|---|---|---|---|---|---|
| 00006-0078-61 | JANUMET XR 50/500MG 60 | EA | n/a | $1.45 | $5.28 | - |
| 00006-0078-62 | JANUMET XR 50/500MG 180 | EA | n/a | $1.45 | $5.28 | - |
| 00006-0078-82 | JANUMET XR 50/500MG 1000 | EA | n/a | $1.45 | $5.28 | - |
| 00006-0080-61 | JANUMET XR 50/1000MG 60 | EA | n/a | $1.45 | $5.28 | - |
| 00006-0080-62 | JANUMET XR 50/1000MG 180 | EA | n/a | $1.45 | $5.28 | - |
| 00006-0080-82 | JANUMET XR 50/1000MG 1000 | EA | n/a | $1.45 | $5.28 | - |
| 00006-0081-31 | JANUMET XR 100/1000MG 30 | EA | n/a | $2.90 | $10.55 | - |
| 00006-0081-54 | JANUMET XR 100/1000MG 90 | EA | n/a | $2.90 | $10.55 | - |
| 00006-0081-82 | JANUMETXR 100/1000MG 1000 | EA | n/a | $2.90 | $10.55 | - |
| 00006-0575-01 | (name not listed) | n/a | n/a | $1.45 | n/a | no NADAC price |
| 00006-0575-52 | (name not listed) | n/a | n/a | $1.45 | n/a | no NADAC price |
| 00006-0575-61 | JANUMET 50/500MG TAB 60CT | EA | n/a | $1.45 | $5.28 | - |
| 00006-0575-62 | JANUMET 50/500MG 180 CT | EA | n/a | $1.45 | $5.28 | - |
| 00006-0575-82 | JANUMET 50/500MG TAB 1000 | EA | n/a | $1.45 | $5.28 | - |
| 00006-0577-01 | (name not listed) | n/a | n/a | $1.45 | n/a | no NADAC price |
| 00006-0577-52 | (name not listed) | n/a | n/a | $1.45 | n/a | no NADAC price |
| 00006-0577-61 | JANUMET 50/1000MG 60 CT | EA | n/a | $1.45 | $5.28 | - |
| 00006-0577-62 | JANUMET 50/1000MG 180 CT | EA | n/a | $1.45 | $5.28 | - |
| 00006-0577-82 | JANUMET 50/1000MG TAB | EA | n/a | $1.45 | $5.28 | - |
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 |
|---|---|---|---|---|---|
| NDA022044 | Janumet 50/1000mg 180 Ct, Janumet 50/1000mg 60 Ct, Janumet 50/1000mg Tab, Janumet 50/500mg 180 Ct and 2 more | January 21, 2029 | none listed | January 21, 2029 | patent 8414921 with its pediatric extension; 8 dated entries listed |
| NDA202270 | Janumet Xr 100/1000mg 30, Janumet Xr 100/1000mg 90, Janumet Xr 50/1000mg 1000, Janumet Xr 50/1000mg 180 and 5 more | May 24, 2027 | none listed | May 24, 2027 | patent 7326708 with its pediatric extension; 6 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 Janumet of $709.18 million in 2024, across 743,903 claims and 159,321 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 | $709.18 million | 743,903 | 159,321 | $953 |
| 2023 | $798.87 million | 776,835 | 168,527 | $1,028 |
| 2022 | $815.61 million | 848,642 | 180,666 | $961 |
| 2021 | $814.64 million | 922,666 | 192,481 | $883 |
| 2020 | $791.89 million | 982,717 | 196,000 | $806 |
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)
- Janumet (application NDA022044): listed as released, without Elements to Assure Safe Use. Program dated February 26, 2010, last modified April 14, 2011. REMS@FDA program page.
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 2 designations for metformin. 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 |
|---|---|---|---|
| December 14, 2017 | Treatment of progressive myoclonus epilepsy type 2 (Lafora disease) | Designated | Consorcio Centro de Investigación Biomédica en Red, M.P. (CIBER) |
| May 29, 2014 | Treatment of pediatric polycystic ovary syndrome | Designated/Designation Withdrawn or Revoked | EffRx Pharmaceuticals SA |
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 10 states with the largest reimbursement are shown of 14 with data. 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 | 293 | $236,347 | All record types |
| CT | 210 | $198,654 | All record types |
| NC | 229 | $182,765 | All record types |
| IN | 239 | $177,069 | Fee-for-service only |
| MN | 172 | $57,454 | Fee-for-service only |
| WV | 63 | $44,526 | All record types |
| PA | 117 | $35,274 | All record types |
| TN | 130 | $31,973 | All record types |
| MA | 94 | $30,785 | Fee-for-service only |
| FL | 93 | $30,575 | All record types |
Where the publisher suppresses small managed-care cells, a state's figure covers fee-for-service claims only and understates use (6 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. 223 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 metformin. 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.
- Merck Helps (Merck Patient Assistance Program) manufacturer
Income at or below $79,800 for one person for KEYTRUDA, or $63,840 for JANUVIA and JANUMET - Teva Cares Foundation manufacturer
Income at or below 250% of the poverty level
Figure not yet re-read on the program's own page. - Viatris (Mylan) Patient Assistance manufacturer
Income at or below 300% of the poverty level
Figure not yet re-read on the program's own page. - Walmart $4 Prescriptions discount
No income limit in our data
Figure not yet re-read on the program's own page. - Mark Cuban Cost Plus Drugs discount
No income limit in our data
Figure not yet re-read on the program's own page.
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 Janumet dated since November 11, 2025, leaving out manufacturing (CMC) changes. 2 changes in the window.
| Date | Class | Application | Submissions | FDA documents |
|---|---|---|---|---|
| August 11, 2026 | Labeling | NDA022044 | 58 | Label (PDF) posted August 18, 2026FDA letter posted August 14, 2026 |
| August 11, 2026 | Labeling | NDA202270 | 31 | Label (PDF) posted August 18, 2026FDA letter posted August 14, 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 Janumet 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 |
|---|---|---|---|---|---|
| April 13, 2022D-0746-2022 | Class II | Terminated | MERCK SHARP & DOHME CORP | Presence of foreign substance: Presence of stainless steel particulates in tablets. | 10 |
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 4 interventional trials that name metformin and are recruiting, and 1 more not yet recruiting. By phase: Phase 4: 2, Phase 3: 1, PHASE1/PHASE2: 1. The 4 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 |
|---|---|---|---|---|---|
| NCT06246799 | Comparative Effectiveness of Two Initial Combination Therapies in Patients With Recent Onset DiabetesType 2 Diabetes (Adult Onset) | Phase 3 | The University of Texas Health Science Center at San Antonio | March 10, 2026 | United States |
| NCT07374328 | Triple Hypoglycemic Regimens In Patients With Newly Diagnosed Type 2 Diabetes MellitusType 2 Diabetes | Phase 1 / Phase 2 | Second Affiliated Hospital of Guangzhou Medical University | January 28, 2026 | China |
| NCT06972732 | A Phase IV Clinical Trial to Compare the Efficacy and Safety of Metformin+Sodium-Glucose Cotransporter 2 Inhibitor(SGLT2-i)+Thiazolidinedione (TZD) in Patients With Type 2 DiabetesType 2 Diabetes | Phase 4 | Boryung Pharmaceutical Co., Ltd | September 15, 2025 | South Korea |
| NCT06875193 | DM Treatment to Evaluate the Efficacy and Safety of Dapagliflozin or Pioglitazone in Patients with Type 2 DiabetesType2diabetes | Phase 4 | Dong Wha Pharmaceutical Co. Ltd. | March 17, 2025 | South Korea |
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 Janumet?
The CMS file publishes $80.00 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 Janumet?
5 assistance programs list 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 Janumet arrive?
For Janumet, the FDA's Orange Book (edition September 2026) lists these latest patent or exclusivity expiry dates by application: NDA022044, January 21, 2029; NDA202270, May 24, 2027. 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 Janumet?
ClinicalTrials.gov lists 4 recruiting interventional trials that name metformin (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 Janumet?
CMS's Medicare Part D spending dataset reports gross spending on Janumet of $709.18 million in 2024, across 743,903 claims and 159,321 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/janumet.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.