Public record

Losartan: the public record

7 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 losartan

The FDA label read for losartan (COZAAR, application NDA020386) was last revised on 2026-01-20. It carries a boxed warning headed "WARNING: FETAL TOXICITY". Of the 4 population sections checked, 4 are present: pregnancy, lactation, pediatric use, geriatric use.

FDA label facts for losartan: the figures
MeasureValueNote
Label revision date2026-01-20
Label readCOZAARNDA020386, brand-name application
Boxed warningYesheading as printed: "WARNING: FETAL TOXICITY"
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 losartan 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 losartan

The earliest FDA approval on file for a losartan product is 1995-04-14. Drugs@FDA lists 27 applications for it and 213 approved supplements, the most recent on 2026-09-25.

FDA approval history for losartan: the figures
MeasureValueNote
Earliest FDA approval on file1995-04-14
Applications with an approval on file27
New drug applications (NDA)2
Generic applications (ANDA)25
Approved supplements213label, manufacturing and efficacy changes
Most recent supplement approval2026-09-25
Sponsoring companies27

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 losartan 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 losartan

The FDA Orange Book lists 25 approved generic applications for losartan, the first approved on 2010-04-06. 3 listed patents on specific brand products have not yet expired, the last on 2041-10-07; generics of other versions are already approved.

Patents and generic approvals for losartan: the figures
MeasureValueNote
Brand-name applications (NDA)2
Approved generic applications (ANDA)25first approved 2010-04-06
Companies with a generic not marked discontinued16
Listed patents not yet expired3
Latest listed patent expiry2041-10-07on any product; may cover only one brand formulation
Earliest approval date on file1995-04-14
Products not marked discontinued52 of 79

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 losartan 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 spending on losartan

Medicare Part D spending on losartan products was $359.5M in 2024 across 36,252,456 claims, compared with $491.9M in 2023 (-26.9%). Average spending per claim was $9.92, before rebates.

Medicare Part D spending on losartan: the figures
MeasureValueNote
Total spending, 2024$359.5M
Total spending, 2023$491.9M
Change in spending, 2023 to 2024-26.9%
Claims (prescription fills), 202436,252,456
Average spending per claim, 2024$9.92
Losartan Potassium: spending, 2024$355.2M36,240,406 claims
Cozaar: spending, 2024$4.4M12,050 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 losartan product in Part D (Losartan Potassium, Cozaar), 2024.

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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Adverse event reports

Most reported events in FDA adverse event reports for losartan

Through 2026-10-28, FDA had received 181,632 adverse event reports for losartan, 113,112 of them marked serious by the reporter. The symptom terms named most often were fatigue (13,097), diarrhoea (11,049) and nausea (10,014).

Most reported events in FDA adverse event reports for losartan: the figures
MeasureValueNote
All reports received181,632
Reports the reporter marked serious113,112death, hospitalisation, disability or similar outcome
Fatigue13,097 reports
Diarrhoea11,049 reports
Nausea10,014 reports
Dyspnoea9,050 reports
Headache8,738 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 drug ineffective) were left out of the list.

Scope: Reports where FDA recorded losartan 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 losartan

FDA enforcement reports list 101 drug recall entries naming losartan from 2014 to 2023-07-12. 85 of them are for compounded or other unlisted products and 16 for products FDA lists under a label. The most common stated reason was impurities or nitrosamines (84 of 101).

FDA drug recalls naming losartan: the figures
MeasureValueNote
Recall entries on record101
For products FDA lists under an approved or registered label16
For compounded or other unlisted products85matched by the name in the product description
Class I (most serious)0
Class II101
Class III0
Most recent recall reported2023-07-12
Most common stated reasonimpurities or nitrosamines84 of 101 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 losartan 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 losartan

ClinicalTrials.gov lists 456 registered studies that name losartan as an intervention as of 2026-11-11. Of these, 28 are recruiting, 273 are completed and 93 are phase 3 studies.

Registered clinical studies of losartan: the figures
MeasureValue
Registered studies456
Recruiting now28
Not yet recruiting10
Completed273
Terminated, withdrawn or suspended57
Phase 3 (including phase 2/3)93
Phase 2 (including phase 1/2)78
Phase 176

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 losartan, 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 Losartan