Help paying · Medicare negotiated price · pharmacy cost · cycle 2027
Linzess (linaclotide): where help paying exists, what Medicare negotiated and what pharmacies pay
Medicare's negotiated price for a 30-day supply is $136 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 3 recruiting trials that name linaclotide.
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 |
|---|---|---|---|---|---|---|
| 00456-1201-30 | LINZESS 145 MCG 30 CT | EA | n/a | $4.55 | $9.02 | - |
| 00456-1202-30 | LINZESS 290 MCG 30 CT | EA | n/a | $4.55 | $9.01 | - |
| 00456-1203-30 | LINZESS 72MCG | EA | n/a | $4.55 | $9.01 | - |
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 |
|---|---|---|---|---|---|
| NDA202811 | Linzess 145 Mcg 30 Ct, Linzess 290 Mcg 30 Ct, Linzess 72mcg | February 16, 2034 | May 21, 2029 | February 16, 2034 | patent 9708371 with its pediatric extension; 35 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 Linzess of $1.98 billion in 2024, across 2,506,531 claims and 632,063 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 | $1.98 billion | 2,506,531 | 632,063 | $791 |
| 2023 | $1.83 billion | 2,263,018 | 565,088 | $807 |
| 2022 | $1.58 billion | 2,113,198 | 510,755 | $748 |
| 2021 | $1.37 billion | 2,005,937 | 481,655 | $685 |
| 2020 | $1.14 billion | 1,820,879 | 428,018 | $629 |
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 2 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 |
|---|---|---|---|
| NH | 654 | $451,941 | Fee-for-service only |
| PR | 61 | $35,824 | All record types |
Where the publisher suppresses small managed-care cells, a state's figure covers fee-for-service claims only and understates use (1 state and package figure is marked that way here). A state missing from the table means its figures were suppressed or not reported, not zero use. 157 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
Offers the program pages state
- Manufacturer savings card
The LINZESS savings page states pay as little as $30 per 30, 60 or 90-day supply for each of up to twelve prescription fills per calendar year, with a maximum annual benefit of $2,280.00 per calendar year, for commercially insured patients. No end date is stated.
Read November 7, 2026; quote matched against the saved page text.
No program in our finder currently lists this drug as open to new patients.
Label changes
FDA actions on the applications behind Linzess dated since November 11, 2025, leaving out manufacturing (CMC) changes. 1 change in the window.
| Date | Class | Application | Submissions | FDA documents |
|---|---|---|---|---|
| May 21, 2026 | Efficacy | NDA202811 | 23 | Label (PDF) posted May 26, 2026FDA letter posted May 26, 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 Linzess 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 |
|---|---|---|---|---|---|
| June 2, 2021D-0417-2021 | Class II | Terminated | Cardinal Health Inc. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | 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 3 interventional trials that name linaclotide and are recruiting, and 2 more not yet recruiting. By phase: Not applicable: 1, Early phase 1: 1, PHASE1/PHASE2: 1. The 3 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 |
|---|---|---|---|---|---|
| NCT05796388 | A Study of Virtual Reality and Linaclotide for IBS-CIrritable Bowel Syndrome With Constipation | Not applicable | Mayo Clinic | July 29, 2026 | United States |
| NCT07569419 | Proof of Principle Study for an Efficacy Trial of Linaclotide for Cystic FibrosisCystic Fibrosis (CF) | Early phase 1 | University of Nottingham | May 6, 2026 | United Kingdom |
| NCT06692673 | Linaclotide for Colonoscopy Bowel PrepPatients Scheduled for Colonoscopy | Phase 1 / Phase 2 | University of Florida | January 23, 2026 | United States |
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 Linzess?
The CMS file publishes $136 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 Linzess?
No program in our finder lists this drug yet.
When could a generic version of Linzess arrive?
For Linzess, the FDA's Orange Book (edition September 2026) lists these latest patent or exclusivity expiry dates by application: NDA202811, February 16, 2034. 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 Linzess?
ClinicalTrials.gov lists 3 recruiting interventional trials that name linaclotide (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 Linzess?
CMS's Medicare Part D spending dataset reports gross spending on Linzess of $1.98 billion in 2024, across 2,506,531 claims and 632,063 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/linzess.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.