Help paying · Medicare negotiated price · pharmacy cost · cycle 2028
Trulicity (dulaglutide): where help paying exists, where Medicare's negotiation stands and what pharmacies pay
1 assistance program lists dulaglutide, each with its income ceiling and when we read it. CMS has selected Trulicity 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. The FDA's enforcement reports name this drug's packages in 3 recall entries. ClinicalTrials.gov lists 8 recruiting trials that name dulaglutide.
Every package CMS lists
Packages the CMS file lists for Trulicity, with NADAC per unit where the benchmark has one (per unit, as the files state).
| NDC | Product | Unit | CMS price status | NADAC |
|---|---|---|---|---|
| 00002-1433-01 | (name not listed) | n/a | Selected; price takes effect January 1, 2028, not yet published | n/a |
| 00002-1433-80 | TRULICITY | ML | Selected; price takes effect January 1, 2028, not yet published | $488 |
| 00002-1434-01 | (name not listed) | n/a | Selected; price takes effect January 1, 2028, not yet published | n/a |
| 00002-1434-80 | TRULICITY | ML | Selected; price takes effect January 1, 2028, not yet published | $488 |
| 00002-2236-01 | (name not listed) | n/a | Selected; price takes effect January 1, 2028, not yet published | n/a |
| 00002-2236-80 | TRULICITY | ML | Selected; price takes effect January 1, 2028, not yet published | $488 |
| 00002-3182-01 | (name not listed) | n/a | Selected; price takes effect January 1, 2028, not yet published | n/a |
| 00002-3182-80 | TRULICITY | ML | Selected; price takes effect January 1, 2028, not yet published | $487 |
Medicare Part D spending
CMS's Medicare Part D spending dataset reports gross spending on Trulicity of $5.45 billion in 2024, across 4,305,141 claims and 788,716 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 | $5.45 billion | 4,305,141 | 788,716 | $1,267 |
| 2023 | $7.36 billion | 5,316,020 | 938,731 | $1,385 |
| 2022 | $6.23 billion | 4,610,823 | 840,163 | $1,350 |
| 2021 | $4.70 billion | 3,704,201 | 663,858 | $1,269 |
| 2020 | $3.28 billion | 2,823,185 | 497,327 | $1,164 |
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.
Biosimilar status
- Trulicity (dulaglutide) is a reference product in the FDA Purple Book (BLA 125469, approved September 18, 2014). The Purple Book lists 0 biosimilars and 0 interchangeable products that name it as their reference product.
This is what the FDA Purple Book lists on the read date. It is a record, not a forecast of when any product will launch or be substituted.
Source: FDA Purple Book (purplebook-2026-10), read November 7, 2026. Purple Book data file.
FDA safety program (REMS)
- Trulicity (application BLA125469): listed as released, without Elements to Assure Safe Use. Program dated September 18, 2014, last modified December 12, 2017. 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.
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 1 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 |
|---|---|---|---|
| WY | 92 | $88,786 | All record types |
A state missing from the table means its figures were suppressed or not reported, not zero use. 209 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 dulaglutide. 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.
- Lilly Cares Foundation manufacturer
Income at or below 300%, 400% or 500% FPL depending on the Lilly Cares group of your medicine ($47,880, $63,840 or $79,800 for one person)
Ceiling read on the program's own document, November 6, 2026.
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 Trulicity dated since November 11, 2025, leaving out manufacturing (CMC) changes. 1 change in the window.
| Date | Class | Application | Submissions | FDA documents |
|---|---|---|---|---|
| March 12, 2026 | Labeling | BLA125469 | 65 | Label (PDF) posted March 18, 2026FDA letter posted March 16, 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 Trulicity by its NDC: 3 entries, 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 25, 2022D-0883-2022 | Class II | Completed | Cardinal Health Inc. | TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather. | 1 |
| May 25, 2022D-0884-2022 | Class II | Completed | Cardinal Health Inc. | TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions | 8 |
| September 1, 2021D-0773-2021 | Class II | Terminated | Eli Lilly & Company | Labeling: Label error on declared strength - autoinjector devices labeled as 0.75 mg / 0.5 mL actually contain 1.5 mg / 0.5 mL of product. | 8 |
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 8 interventional trials that name dulaglutide and are recruiting, and 4 more not yet recruiting. By phase: Phase 2: 3, Phase 3: 2, Phase 4: 2, PHASE2/PHASE3: 1. The 8 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 |
|---|---|---|---|---|---|
| NCT07668336 | A Study of Orforglipron (LY3502970) Compared With Dulaglutide in Pediatric Participants With Type 2 DiabetesDiabetes Mellitus, Type 2 | Phase 3 | Eli Lilly and Company | November 5, 2026 | United States, Belgium, Brazil and 7 more |
| NCT05478707 | Therapeutic Strategies for Microvascular Dysfunction in Type 1 DiabetesDiabetes Mellitus, Type 1; Endothelial Dysfunction | Phase 2 | AdventHealth Translational Research Institute | October 15, 2026 | United States |
| NCT06739122 | A Study of Dulaglutide (LY2189265) 3.0 mg and 4.5 mg in Pediatric Participants With Type 2 Diabetes Mellitus (AWARD-PEDS PLUS)Type 2 Diabetes | Phase 3 | Eli Lilly and Company | August 7, 2026 | United States, Argentina, Mexico |
| NCT04731272 | GLP-1 Agonist Therapy in Cystic Fibrosis-Related Glucose IntoleranceCystic Fibrosis; Pancreatic Insufficiency; Abnormal Glucose Tolerance | Phase 2 | University of Pennsylvania | May 18, 2026 | United States |
| NCT06324461 | GLP-1 Receptor Agonist for Reduction of Myocardial Injury After Non-cardiac SurgeryMyocardial Injury | Phase 4 | The University of Hong Kong | May 4, 2026 | China |
| NCT05390892 | PREvention of CardIovascular and DiabEtic kidNey Disease in Type 2 DiabetesType2Diabetes; ASCVD | Phase 4 | Brigham and Women's Hospital | April 13, 2026 | United States |
| NCT07282041 | Role of GLP1 RA Dulaglutide on Severe Intracranial AtherosclerosisIntracranial Atherosclerosis; Stroke, Ischemic | Phase 2 / Phase 3 | National University of Singapore | December 23, 2025 | Singapore |
| NCT07109700 | A Study of HDM1005 in Participants With T2DM Not Controlled With Diet/Exercise or MetforminType 2 Diabetes | Phase 2 | Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. | August 17, 2025 | 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 Trulicity?
CMS has selected Trulicity 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 Trulicity?
1 assistance program lists it in our finder. Eligibility depends on income, coverage and the program's current rules; each program's own page decides.
Can I join a clinical trial for Trulicity?
ClinicalTrials.gov lists 8 recruiting interventional trials that name dulaglutide (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 Trulicity?
CMS's Medicare Part D spending dataset reports gross spending on Trulicity of $5.45 billion in 2024, across 4,305,141 claims and 788,716 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/trulicity.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 Purple Book; 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.