Public record
Zoledronic acid: the public record
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.
| Measure | Value | Note |
|---|---|---|
| Label revision date | 2026-02-03 | |
| Label read | Reclast | NDA021817, brand-name application |
| Boxed warning | No | |
| Pregnancy section | Present | |
| Lactation section | Present | |
| Pediatric use section | Present | |
| Geriatric use section | Present |
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.
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.
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.
| Measure | Value | Note |
|---|---|---|
| Earliest FDA approval on file | 2001-08-20 | |
| Applications with an approval on file | 54 | |
| New drug applications (NDA) | 6 | |
| Generic applications (ANDA) | 48 | |
| Approved supplements | 168 | label, manufacturing and efficacy changes |
| Most recent supplement approval | 2026-05-20 | |
| Sponsoring companies | 32 |
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.
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.
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.
| Measure | Value | Note |
|---|---|---|
| Brand-name applications (NDA) | 4 | |
| Approved generic applications (ANDA) | 37 | first approved 2013-03-04 |
| Companies with a generic not marked discontinued | 15 | |
| Listed patents not yet expired | 2 | |
| Latest listed patent expiry | 2028-08-05 | on any product; may cover only one brand formulation |
| Earliest approval date on file | 2001-08-20 | |
| Products not marked discontinued | 26 of 43 |
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.
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.
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.
| Measure | Value | Note |
|---|---|---|
| All states and territories, 2024 | 3,937 claims | |
| States and territories with reported claims | 23 | |
| California | 1,481 claims | $79,980 gross drug cost |
| Florida | 636 claims | $44,473 gross drug cost |
| New York | 559 claims | $131,874 gross drug cost |
| New Jersey | 314 claims | $80,700 gross drug cost |
| Texas | 183 claims | $14,697 gross drug cost |
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.
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.
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.
| Measure | Value |
|---|---|
| Total spending, 2024 | $438,227 |
| Total spending, 2023 | $777,184 |
| Change in spending, 2023 to 2024 | -43.6% |
| Claims (prescription fills), 2024 | 3,990 |
| Average spending per claim, 2024 | $110 |
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.
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.
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.
| Measure | Value | Note |
|---|---|---|
| Prescriptions paid by Medicaid, 2025 | 27,830 | |
| Total reimbursed before rebates, 2025 | $2.8M | |
| States and territories reporting | 46 | with at least one count CMS did not suppress |
| California | 4,024 prescriptions | $500,925 reimbursed |
| Florida | 2,569 prescriptions | $65,578 reimbursed |
| New York | 2,167 prescriptions | $765,863 reimbursed |
| Puerto Rico | 1,829 prescriptions | $268,411 reimbursed |
| Texas | 1,365 prescriptions | $57,403 reimbursed |
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.
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.
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.
| Measure | Value |
|---|---|
| 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% |
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.
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.
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).
| Measure | Value | Note |
|---|---|---|
| All reports received | 66,921 | |
| Reports the reporter marked serious | 55,327 | death, hospitalisation, disability or similar outcome |
| Osteonecrosis of jaw | 5,978 reports | |
| Fatigue | 5,812 reports | |
| Diarrhoea | 4,554 reports | |
| Pain | 4,414 reports | |
| Nausea | 4,345 reports |
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.
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.
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).
| Measure | Value | Note |
|---|---|---|
| Recall entries on record | 7 | |
| For products FDA lists under an approved or registered label | 1 | |
| For compounded or other unlisted products | 6 | matched by the name in the product description |
| Class I (most serious) | 0 | |
| Class II | 4 | |
| Class III | 3 | |
| Most recent recall reported | 2024-06-05 | |
| Most common stated reason | lack of sterility assurance | 3 of 7 entries |
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.
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.
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.
| Measure | Value |
|---|---|
| Registered studies | 407 |
| Recruiting now | 27 |
| Not yet recruiting | 9 |
| Completed | 248 |
| Terminated, withdrawn or suspended | 60 |
| Phase 3 (including phase 2/3) | 119 |
| Phase 2 (including phase 1/2) | 100 |
| Phase 1 | 29 |
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.
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.
Articles on Zoledronic acid
- Does Blue Cross Blue Shield Cover Reclast (Zoledronic Acid)? Prior Authorization, Formulary Tier, and Appeal Steps
- Does Humana Cover Reclast (Zoledronic Acid)? Prior Authorization, Formulary Tier, and Appeal Steps
- Does Kaiser Permanente Cover Reclast (Zoledronic Acid)?
- Reclast (Zoledronic Acid) Manufacturing, Supply & Shortage History
- Reclast (Zoledronic Acid) Monitoring Schedule: Labs & Exams Before and After Each Infusion
- Reclast (Zoledronic Acid) Safety Signals and FDA Actions