Help paying · Medicare negotiated price · pharmacy cost · cycle 2028
Anoro Ellipta (umeclidinium): where help paying exists, where Medicare's negotiation stands and what pharmacies pay
CMS has selected Anoro Ellipta 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. The FDA's enforcement reports name this drug's packages in 1 recall entry. ClinicalTrials.gov lists 4 recruiting trials that name umeclidinium.
Every package CMS lists
Packages the CMS file lists for Anoro Ellipta, with NADAC per unit where the benchmark has one (per unit, as the files state).
| NDC | Product | Unit | CMS price status | NADAC |
|---|---|---|---|---|
| 00173-0869-06 | ANORO ELLIPTA 62.5/25 MCGINH PWDR 1X7 DS INST | EA | Selected; price takes effect January 1, 2028, not yet published | $8.03 |
| 00173-0869-10 | ANORO ELLIPTA 62.5/25 MCGINH PWDR 1X30 DS | EA | Selected; price takes effect January 1, 2028, not yet published | $7.80 |
| 66993-0134-97 | UMEC and Vilanterol Ellipta 62.5/25mcg | EA | Selected; price takes effect January 1, 2028, not yet published | $4.94 |
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 |
|---|---|---|---|---|---|
| NDA203975 | Anoro Ellipta 62.5/25 Mcginh Pwdr 1x30 Ds, Anoro Ellipta 62.5/25 Mcginh Pwdr 1x7 Ds Inst, Umec And Vilanterol Ellipta 62.5/25mcg | November 29, 2030 | none listed | November 29, 2030 | patent 11090294; 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 Anoro Ellipta of $819.26 million in 2024, across 1,383,988 claims and 291,195 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 | $819.26 million | 1,383,988 | 291,195 | $592 |
| 2023 | $872.96 million | 1,390,293 | 294,512 | $628 |
| 2022 | $866.85 million | 1,439,975 | 297,142 | $602 |
| 2021 | $912.37 million | 1,593,170 | 338,712 | $573 |
| 2020 | $1.00 billion | 1,830,197 | 375,201 | $548 |
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 4 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 |
|---|---|---|---|
| FL | 153 | $19,553 | Fee-for-service only |
| IN | 110 | $12,733 | Fee-for-service only |
| TN | 78 | $11,188 | All record types |
| KY | 191 | $7,347 | 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. 62 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
The FDA file lists no non-manufacturing label change for these applications since November 11, 2025. The most recent one it lists is dated June 2, 2023 (Labeling).
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 Anoro Ellipta 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 |
|---|---|---|---|---|---|
| January 3, 2024D-0160-2024 | Class III | Terminated | GlaxoSmithKline LLC | Failed Release Testing: Coarse Particle Mass for umeclidinium Out of Specification | 2 |
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 umeclidinium and are recruiting, and 2 more not yet recruiting. By phase: Phase 4: 2, Phase 2: 1, Phase 3: 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 |
|---|---|---|---|---|---|
| NCT07133880 | Compare the Effects of Nebulizer Versus Inhaler Based Therapy for COPD Using Long-acting BronchodilatorsCOPD (Chronic Obstructive Pulmonary Disease) | Phase 4 | University of Tennessee Graduate School of Medicine | October 19, 2026 | United States |
| NCT07192016 | 129-Xe MRI Study of Single Triple Therapy Inhaler Effects in COPD Patients With Moderate-severe Dyspnea and/or Poor Health Status With High or Low Risk of ExacerbationChronic Obstructive Pulmonary Disease (COPD) | Phase 4 | Western University, Canada | July 31, 2026 | Canada |
| NCT07282886 | VENTURI (VENTilation Using Respiratory Imaging)Asthma | Phase 2 | University of Alabama at Birmingham | April 13, 2026 | United States |
| NCT06474039 | The Efficacy of Fluticasone Furoate/Vilanterol/Umeclidinium Compared With Vilanterol/Umeclidinium in Reducing Air Trapping and Airway and Blood Cytokine Levels in COPDCOPD | Phase 3 | Mahidol University | May 6, 2025 | Thailand |
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 Anoro Ellipta?
CMS has selected Anoro Ellipta 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 Anoro Ellipta?
No program in our finder lists this drug yet.
When could a generic version of Anoro Ellipta arrive?
For Anoro Ellipta, the FDA's Orange Book (edition September 2026) lists these latest patent or exclusivity expiry dates by application: NDA203975, November 29, 2030. 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 Anoro Ellipta?
ClinicalTrials.gov lists 4 recruiting interventional trials that name umeclidinium (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 Anoro Ellipta?
CMS's Medicare Part D spending dataset reports gross spending on Anoro Ellipta of $819.26 million in 2024, across 1,383,988 claims and 291,195 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/anoro-ellipta.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.