Public record

Liraglutide: the public record

11 tables from US federal sources. Latest data date: Nov 11, 2026.

Each table is computed from the named federal dataset as of its data date; the method is under each one.

Label

FDA label facts for liraglutide

The FDA label read for liraglutide (Saxenda, application NDA206321) was last revised on 2026-02-25. It carries a boxed warning headed "WARNING: RISK OF THYROID C-CELL TUMORS". Of the 4 population sections checked, 4 are present: pregnancy, lactation, pediatric use, geriatric use.

FDA label facts for liraglutide: the figures
MeasureValueNote
Label revision date2026-02-25
Label readSaxendaNDA206321, brand-name application
Boxed warningYesheading as printed: "WARNING: RISK OF THYROID C-CELL TUMORS"
Pregnancy sectionPresent
Lactation sectionPresent
Pediatric use sectionPresent
Geriatric use sectionPresent

Source: FDA drug label via openFDA, viewable on NIH DailyMed, data as of Nov 11, 2026

How this was calculated

Selected the most recently revised prescription label for this single ingredient from an original manufacturer, preferring a brand-name application. Checked which sections exist and quoted headings and sentences exactly as printed.

Scope: One label: the newest prescription label for single-ingredient liraglutide from an original manufacturer

Read from one label. Labels for other brands, strengths or forms of the same ingredient can differ. A missing section heading does not mean there is no guidance. Read the full label before relying on it.

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Approvals

FDA approval history for liraglutide

The earliest FDA approval on file for a liraglutide product is 2010-01-25. Drugs@FDA lists 13 applications for it and 48 approved supplements, the most recent on 2026-06-02.

FDA approval history for liraglutide: the figures
MeasureValueNote
Earliest FDA approval on file2010-01-25
Applications with an approval on file13
New drug applications (NDA)2
Generic applications (ANDA)11
Approved supplements48label, manufacturing and efficacy changes
Most recent supplement approval2026-06-02
Sponsoring companies11

Source: FDA, Drugs@FDA, data as of Nov 11, 2026

How this was calculated

Selected applications with a product whose only active ingredient is this substance, then counted approved original and supplemental submissions. The earliest approved original submission is the first approval.

Scope: Applications with a single-ingredient liraglutide product in Drugs@FDA, all sponsors and strengths

Older approvals can be missing dates, and tentative approvals are not counted. An approved application does not mean the product is currently marketed.

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Patents and generics

Patents and generic approvals for liraglutide

The FDA Orange Book lists 11 approved generic applications for liraglutide, the first approved on 2024-12-23. 2 listed patents on specific brand products have not yet expired, the last on 2037-07-09; generics of other versions are already approved.

Patents and generic approvals for liraglutide: the figures
MeasureValueNote
Brand-name applications (NDA)2
Approved generic applications (ANDA)11first approved 2024-12-23
Companies with a generic not marked discontinued9
Listed patents not yet expired2
Latest listed patent expiry2037-07-09on any product; may cover only one brand formulation
Earliest approval date on file2010-01-25
Products not marked discontinued13 of 13

Source: FDA, Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations), data as of Oct 9, 2026

How this was calculated

Selected Orange Book products whose only active ingredient is this substance, then counted applications by type and the distinct patents and exclusivities listed against them. Expired patents are left out.

Scope: All single-ingredient liraglutide products in the Orange Book, every brand and strength, files dated 2026-10-09

An approved generic or an expired patent does not show that a generic is on sale. Launch timing also depends on litigation, settlements and supply. Biologics and compounded products are not in the Orange Book.

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Medicare Part D

Medicare Part D claims for liraglutide by age group

Of 351,738 Medicare Part D claims for liraglutide in 2024, 295,221 (83.9%) were for enrollees aged 65 and over and 56,517 were for enrollees under 65.

Medicare Part D claims for liraglutide by age group: the figures
MeasureValueNote
All Part D claims, 2024351,738
Claims for enrollees aged 65 and over295,221
Claims for enrollees under 6556,517mostly people who qualify through disability
Share of claims for enrollees aged 65 and over83.9%share of claims, not of patients

Source: CMS, Medicare Part D Prescribers by Geography and Drug, data as of 2024

How this was calculated

Summed the national rows for every brand and generic row with this generic name. Claims under 65 are total claims minus claims for enrollees 65 and over.

Scope: National Part D claims for single-ingredient liraglutide products, 2024, split at age 65

Medicare mostly covers people 65 and over, so this split describes Medicare enrollees and not use in the general population.

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Medicare Part D

Medicare Part D claims for liraglutide by state

California had the most Medicare Part D claims for liraglutide in 2024 (69,230), followed by New York (16,676) and Pennsylvania (16,404). Prescribers in 55 states and territories wrote 351,707 claims in all.

Medicare Part D claims for liraglutide by state: the figures
MeasureValueNote
All states and territories, 2024351,707 claims
States and territories with reported claims55
California69,230 claims$53.2M gross drug cost
New York16,676 claims$17.1M gross drug cost
Pennsylvania16,404 claims$16.3M gross drug cost
Ohio15,676 claims$14.9M gross drug cost
Texas14,711 claims$14.6M gross drug cost

Source: CMS, Medicare Part D Prescribers by Geography and Drug, data as of 2024

How this was calculated

Summed claims and drug cost by prescriber state over every brand and generic row with this generic name. Combination products excluded. Rows CMS suppressed for small counts are left out.

Scope: Part D claims for single-ingredient liraglutide products by the prescriber's state, 2024

State counts follow population size and where the prescriber practises. They are not per-person rates and do not show any state's coverage rules.

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Medicare Part D

Medicare Part D spending on liraglutide

Medicare Part D spending on liraglutide products was $329.0M in 2024 across 351,843 claims, compared with $1.32B in 2023 (-75.1%). Average spending per claim was $935, before rebates.

Medicare Part D spending on liraglutide: the figures
MeasureValueNote
Total spending, 2024$329.0M
Total spending, 2023$1.32B
Change in spending, 2023 to 2024-75.1%
Claims (prescription fills), 2024351,843
Average spending per claim, 2024$935
Victoza 3-Pak: spending, 2024$203.1M181,068 claims
Victoza 2-Pak: spending, 2024$77.8M108,521 claims
Liraglutide: spending, 2024$48.1M62,254 claims

Source: CMS, Medicare Part D Spending by Drug, data as of 2024

How this was calculated

Summed total spending and claims over every brand and generic row with this generic name in the CMS file, using the Overall manufacturer rows. Combination products excluded. Average per claim is spending divided by claims.

Scope: Every single-ingredient liraglutide product in Part D (Victoza 3-Pak, Victoza 2-Pak, Liraglutide), 2024. Not limited to Saxenda.

Gross drug cost before manufacturer rebates, so net cost is lower. Part D excludes some uses by law (for example erectile dysfunction, weight loss and hair growth), so claims reflect covered uses only. Compounded products are not included.

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Medicaid

Medicaid prescriptions for liraglutide by state

State Medicaid programmes paid for 259,010 liraglutide prescriptions in 2025, with $143.9M reimbursed before rebates. Washington reported the most (48,552), followed by New Jersey (30,995) and California (24,440); 50 states and territories reported any.

Medicaid prescriptions for liraglutide by state: the figures
MeasureValueNote
Prescriptions paid by Medicaid, 2025259,010
Total reimbursed before rebates, 2025$143.9M
States and territories reporting50with at least one count CMS did not suppress
Washington48,552 prescriptions$19.3M reimbursed
New Jersey30,995 prescriptions$13.5M reimbursed
California24,440 prescriptions$19.8M reimbursed
Illinois17,931 prescriptions$9.1M reimbursed
Virginia16,320 prescriptions$14.2M reimbursed

Source: CMS, Medicaid State Drug Utilization Data 2025, data as of 2025

How this was calculated

Matched each Medicaid product code to the FDA NDC Directory by labeler and product code, kept finished single-ingredient products, then summed prescriptions and reimbursement by state. National roll-up and suppressed rows dropped.

Scope: All single-ingredient liraglutide products in the FDA NDC Directory, fee-for-service and managed care, 2025

Counts under 11 are suppressed by CMS and left out, so totals are a floor. Amounts are before rebates. Differences between states reflect programme size and coverage rules. Compounded products are not included.

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Pharmacy cost

Pharmacy acquisition cost (NADAC) for liraglutide

Retail pharmacies paid an average of $28.58 per mL for LIRAGLUTIDE 2-PAK 18 MG/3 ML as of 2026-11-11, compared with $57.77 twelve months earlier (-50.5%). This is a pharmacy purchase cost, not a patient price.

Pharmacy acquisition cost (NADAC) for liraglutide: the figures
MeasureValueNote
LIRAGLUTIDE 2-PAK 18 MG/3 ML$28.58 per mL12 months earlier $57.77 (-50.5%)
LIRAGLUTIDE 3-PAK 18 MG/3 ML$29.19 per mL12 months earlier $53.29 (-45.2%)
LIRAGLUTIDE 5-PAK 18 MG/3 ML$47.27 per mLno price on file 12 months earlier

Source: CMS, National Average Drug Acquisition Cost (NADAC), data as of Nov 11, 2026

How this was calculated

Matched NADAC product codes to the FDA NDC Directory, kept finished single-ingredient products, and listed the product descriptions with the most package codes. The earlier price is the same package code in the file one year before.

Scope: Generic versions of liraglutide in the weekly NADAC file of 2026-11-11, compared with the file of 2025-11-12

NADAC is the average invoice price retail pharmacies pay, from a voluntary survey. It leaves out rebates, dispensing fees and markups, and it is not what a patient or insurer pays. Compounded products are not surveyed.

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Adverse event reports

Most reported events in FDA adverse event reports for liraglutide

Through 2026-10-28, FDA had received 36,730 adverse event reports for liraglutide, 19,773 of them marked serious by the reporter. The symptom terms named most often were nausea (4,448), vomiting (2,597) and blood glucose increased (2,499).

Most reported events in FDA adverse event reports for liraglutide: the figures
MeasureValueNote
All reports received36,730
Reports the reporter marked serious19,773death, hospitalisation, disability or similar outcome
Nausea4,448 reports
Vomiting2,597 reports
Blood glucose increased2,499 reports
Diarrhoea2,318 reports
Pancreatitis1,556 reports

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, data as of Oct 28, 2026

How this was calculated

Counted FAERS reports listing this active substance, then the reaction terms named most often. A report can name several reactions, and a term can describe the illness being treated and not an effect of the drug. Terms about product use or complaints rather than symptoms (for example off label use) were left out of the list.

Scope: Reports where FDA recorded liraglutide as a single-ingredient active substance (any brand), all years to 2026-10-28

FAERS reports are unverified and do not prove the drug caused the event. Reporting rises with use, publicity and lawsuits, so these counts cannot give rates or risks and cannot be compared between drugs.

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Recalls

FDA drug recalls naming liraglutide

FDA enforcement reports list 3 drug recall entries naming liraglutide from 2021 to 2026-05-27. 1 of them are for compounded or other unlisted products and 2 for products FDA lists under a label. The most common stated reason was other reasons (2 of 3).

FDA drug recalls naming liraglutide: the figures
MeasureValueNote
Recall entries on record3
For products FDA lists under an approved or registered label2
For compounded or other unlisted products1matched by the name in the product description
Class I (most serious)0
Class II3
Class III0
Most recent recall reported2026-05-27
Most common stated reasonother reasons2 of 3 entries

Source: FDA, Enforcement Reports (drug recalls) via openFDA, data as of Nov 10, 2026

How this was calculated

Counted enforcement report entries matched by FDA's listed active substance, or by the name in the product description where FDA lists none. Reasons were grouped by keywords in FDA's stated reason.

Scope: Recalls of single-ingredient liraglutide products, plus compounded or unlisted products whose description names it

Each recall covers specific lots from one firm and is not a statement about every product with this ingredient. One event can appear as several entries, one per product.

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Clinical studies

Registered clinical studies of liraglutide

ClinicalTrials.gov lists 521 registered studies that name liraglutide as an intervention as of 2026-11-11. Of these, 26 are recruiting, 368 are completed and 113 are phase 3 studies.

Registered clinical studies of liraglutide: the figures
MeasureValue
Registered studies521
Recruiting now26
Not yet recruiting6
Completed368
Terminated, withdrawn or suspended38
Phase 3 (including phase 2/3)113
Phase 2 (including phase 1/2)73
Phase 169

Source: NIH National Library of Medicine, ClinicalTrials.gov, data as of Nov 11, 2026

How this was calculated

Searched the ClinicalTrials.gov intervention field for the name, downloaded every matching record and counted by overall status and phase. Combined phases are counted under the higher phase. Phase not applicable covers observational, device and behavioural studies.

Scope: Studies whose intervention field matches liraglutide, any condition, any country, all statuses

A registered study is not a result. Counts include studies where the drug is a comparator or background treatment, and studies that never finished or reported.

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Articles on Liraglutide