Public record

Zoledronic acid: the public record

10 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 zoledronic acid

The FDA label read for zoledronic acid (Reclast, application NDA021817) was last revised on 2026-02-03. It carries no boxed warning. Of the 4 population sections checked, 4 are present: pregnancy, lactation, pediatric use, geriatric use.

FDA label facts for zoledronic acid: the figures
MeasureValueNote
Label revision date2026-02-03
Label readReclastNDA021817, brand-name application
Boxed warningNo
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 zoledronic acid 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.

Download the data (CSV)

Approvals

FDA approval history for zoledronic acid

The earliest FDA approval on file for a zoledronic acid product is 2001-08-20. Drugs@FDA lists 54 applications for it and 168 approved supplements, the most recent on 2026-05-20.

FDA approval history for zoledronic acid: the figures
MeasureValueNote
Earliest FDA approval on file2001-08-20
Applications with an approval on file54
New drug applications (NDA)6
Generic applications (ANDA)48
Approved supplements168label, manufacturing and efficacy changes
Most recent supplement approval2026-05-20
Sponsoring companies32

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 zoledronic acid 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.

Download the data (CSV)

Patents and generics

Patents and generic approvals for zoledronic acid

The FDA Orange Book lists 37 approved generic applications for zoledronic acid, the first approved on 2013-03-04. 2 listed patents on specific brand products have not yet expired, the last on 2028-08-05; generics of other versions are already approved.

Patents and generic approvals for zoledronic acid: the figures
MeasureValueNote
Brand-name applications (NDA)4
Approved generic applications (ANDA)37first approved 2013-03-04
Companies with a generic not marked discontinued15
Listed patents not yet expired2
Latest listed patent expiry2028-08-05on any product; may cover only one brand formulation
Earliest approval date on file2001-08-20
Products not marked discontinued26 of 43

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 zoledronic acid 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.

Download the data (CSV)

Medicare Part D

Medicare Part D claims for zoledronic acid by state

California had the most Medicare Part D claims for zoledronic acid in 2024 (1,481), followed by Florida (636) and New York (559). Prescribers in 23 states and territories wrote 3,937 claims in all.

Medicare Part D claims for zoledronic acid by state: the figures
MeasureValueNote
All states and territories, 20243,937 claims
States and territories with reported claims23
California1,481 claims$79,980 gross drug cost
Florida636 claims$44,473 gross drug cost
New York559 claims$131,874 gross drug cost
New Jersey314 claims$80,700 gross drug cost
Texas183 claims$14,697 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 zoledronic acid 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.

Download the data (CSV)

Medicare Part D

Medicare Part D spending on zoledronic acid

Medicare Part D spending on zoledronic acid products was $438,227 in 2024 across 3,990 claims, compared with $777,184 in 2023 (-43.6%). Average spending per claim was $110, before rebates.

Medicare Part D spending on zoledronic acid: the figures
MeasureValue
Total spending, 2024$438,227
Total spending, 2023$777,184
Change in spending, 2023 to 2024-43.6%
Claims (prescription fills), 20243,990
Average spending per claim, 2024$110

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 zoledronic acid product in Part D (Zoledronic Acid), 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.

Download the data (CSV)

Medicaid

Medicaid prescriptions for zoledronic acid by state

State Medicaid programmes paid for 27,830 zoledronic acid prescriptions in 2025, with $2.8M reimbursed before rebates. California reported the most (4,024), followed by Florida (2,569) and New York (2,167); 46 states and territories reported any.

Medicaid prescriptions for zoledronic acid by state: the figures
MeasureValueNote
Prescriptions paid by Medicaid, 202527,830
Total reimbursed before rebates, 2025$2.8M
States and territories reporting46with at least one count CMS did not suppress
California4,024 prescriptions$500,925 reimbursed
Florida2,569 prescriptions$65,578 reimbursed
New York2,167 prescriptions$765,863 reimbursed
Puerto Rico1,829 prescriptions$268,411 reimbursed
Texas1,365 prescriptions$57,403 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 zoledronic acid 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.

Download the data (CSV)

Pharmacy cost

Pharmacy acquisition cost (NADAC) for zoledronic acid

Retail pharmacies paid an average of $0.4657 per mL for ZOLEDRONIC ACID 5 MG/100 ML as of 2026-11-11, compared with $0.6129 twelve months earlier (-24.0%). This is a pharmacy purchase cost, not a patient price.

Pharmacy acquisition cost (NADAC) for zoledronic acid: the figures
MeasureValue
ZOLEDRONIC ACID 5 MG/100 ML, now$0.4657 per mL
ZOLEDRONIC ACID 5 MG/100 ML, 12 months earlier$0.6129 per mL
Change over 12 months-24.0%

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 zoledronic acid 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.

Download the data (CSV)

Adverse event reports

Most reported events in FDA adverse event reports for zoledronic acid

Through 2026-10-28, FDA had received 66,921 adverse event reports for zoledronic acid, 55,327 of them marked serious by the reporter. The symptom terms named most often were osteonecrosis of jaw (5,978), fatigue (5,812) and diarrhoea (4,554).

Most reported events in FDA adverse event reports for zoledronic acid: the figures
MeasureValueNote
All reports received66,921
Reports the reporter marked serious55,327death, hospitalisation, disability or similar outcome
Osteonecrosis of jaw5,978 reports
Fatigue5,812 reports
Diarrhoea4,554 reports
Pain4,414 reports
Nausea4,345 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 death) were left out of the list.

Scope: Reports where FDA recorded zoledronic acid 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.

Download the data (CSV)

Recalls

FDA drug recalls naming zoledronic acid

FDA enforcement reports list 7 drug recall entries naming zoledronic acid from 2014 to 2024-06-05. 6 of them are for compounded or other unlisted products and 1 for products FDA lists under a label. The most common stated reason was lack of sterility assurance (3 of 7).

FDA drug recalls naming zoledronic acid: the figures
MeasureValueNote
Recall entries on record7
For products FDA lists under an approved or registered label1
For compounded or other unlisted products6matched by the name in the product description
Class I (most serious)0
Class II4
Class III3
Most recent recall reported2024-06-05
Most common stated reasonlack of sterility assurance3 of 7 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 zoledronic acid 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.

Download the data (CSV)

Clinical studies

Registered clinical studies of zoledronic acid

ClinicalTrials.gov lists 407 registered studies that name zoledronic acid as an intervention as of 2026-11-11. Of these, 27 are recruiting, 248 are completed and 119 are phase 3 studies.

Registered clinical studies of zoledronic acid: the figures
MeasureValue
Registered studies407
Recruiting now27
Not yet recruiting9
Completed248
Terminated, withdrawn or suspended60
Phase 3 (including phase 2/3)119
Phase 2 (including phase 1/2)100
Phase 129

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 zoledronic acid, 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.

Download the data (CSV)

Articles on Zoledronic acid