Public record
Minoxidil: the public record
Each table is computed from the named federal dataset as of its data date; the method is under each one.
Approvals
FDA approval history for minoxidil
The earliest FDA approval on file for a minoxidil product is 1979-10-18. Drugs@FDA lists 37 applications for it and 195 approved supplements, the most recent on 2026-09-04.
| Measure | Value | Note |
|---|---|---|
| Earliest FDA approval on file | 1979-10-18 | |
| Applications with an approval on file | 37 | |
| New drug applications (NDA) | 4 | |
| Generic applications (ANDA) | 33 | |
| Approved supplements | 195 | label, manufacturing and efficacy changes |
| Most recent supplement approval | 2026-09-04 | |
| Sponsoring companies | 24 |
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 minoxidil 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 minoxidil
The FDA Orange Book lists 33 approved generic applications for minoxidil, the first approved on 1987-03-03. No unexpired patents are listed for it.
| Measure | Value | Note |
|---|---|---|
| Brand-name applications (NDA) | 4 | |
| Approved generic applications (ANDA) | 33 | first approved 1987-03-03 |
| Companies with a generic not marked discontinued | 11 | |
| Listed patents not yet expired | 0 | |
| Earliest approval date on file | before 1982 | |
| Products not marked discontinued | 30 of 49 |
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 minoxidil 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 minoxidil by age group
Of 603,284 Medicare Part D claims for minoxidil in 2024, 516,008 (85.5%) were for enrollees aged 65 and over and 87,276 were for enrollees under 65.
| Measure | Value | Note |
|---|---|---|
| All Part D claims, 2024 | 603,284 | |
| Claims for enrollees aged 65 and over | 516,008 | |
| Claims for enrollees under 65 | 87,276 | mostly people who qualify through disability |
| Share of claims for enrollees aged 65 and over | 85.5% | share of claims, not of patients |
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.
National Part D claims for single-ingredient minoxidil 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.
Medicare Part D
Medicare Part D claims for minoxidil by state
California had the most Medicare Part D claims for minoxidil in 2024 (75,311), followed by Texas (51,031) and Florida (43,341). Prescribers in 55 states and territories wrote 603,254 claims in all.
| Measure | Value | Note |
|---|---|---|
| All states and territories, 2024 | 603,254 claims | |
| States and territories with reported claims | 55 | |
| California | 75,311 claims | $1.1M gross drug cost |
| Texas | 51,031 claims | $794,299 gross drug cost |
| Florida | 43,341 claims | $666,498 gross drug cost |
| New York | 40,909 claims | $530,939 gross drug cost |
| Georgia | 21,295 claims | $298,941 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 minoxidil 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 minoxidil
Medicare Part D spending on minoxidil products was $8.8M in 2024 across 603,619 claims, compared with $9.0M in 2023 (-1.8%). Average spending per claim was $14.60, before rebates.
| Measure | Value |
|---|---|
| Total spending, 2024 | $8.8M |
| Total spending, 2023 | $9.0M |
| Change in spending, 2023 to 2024 | -1.8% |
| Claims (prescription fills), 2024 | 603,619 |
| Average spending per claim, 2024 | $14.60 |
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 minoxidil product in Part D (Minoxidil), 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 minoxidil by state
State Medicaid programmes paid for 204,032 minoxidil prescriptions in 2025, with $2.5M reimbursed before rebates. California reported the most (44,971), followed by New York (24,741) and Michigan (9,535); 52 states and territories reported any.
| Measure | Value | Note |
|---|---|---|
| Prescriptions paid by Medicaid, 2025 | 204,032 | |
| Total reimbursed before rebates, 2025 | $2.5M | |
| States and territories reporting | 52 | with at least one count CMS did not suppress |
| California | 44,971 prescriptions | $772,729 reimbursed |
| New York | 24,741 prescriptions | $366,726 reimbursed |
| Michigan | 9,535 prescriptions | $59,370 reimbursed |
| Ohio | 7,973 prescriptions | $100,270 reimbursed |
| Pennsylvania | 7,257 prescriptions | $77,212 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 minoxidil 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 minoxidil
Retail pharmacies paid an average of $0.1506 per unit for MINOXIDIL 10 MG TABLET as of 2026-11-11, compared with $0.2034 twelve months earlier (-26.0%). This is a pharmacy purchase cost, not a patient price.
| Measure | Value | Note |
|---|---|---|
| MINOXIDIL 10 MG TABLET | $0.1506 per unit | 12 months earlier $0.2034 (-26.0%) |
| MINOXIDIL 2.5 MG TABLET | $0.0969 per unit | 12 months earlier $0.0970 (-0.1%) |
| MINOXIDIL 2% SOLUTION | $0.2415 per mL | no price on file 12 months earlier |
| MINOXIDIL 5% SOLUTION | $0.2705 per mL | no price on file 12 months earlier |
| MINOXIDIL FOR MEN 5% FOAM | $0.2244 per gram | no price on file 12 months earlier |
| MINOXIDIL FOR WOMEN 5% FOAM | $0.2244 per gram | no price on file 12 months earlier |
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 minoxidil 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.
Recalls
FDA drug recalls naming minoxidil
FDA enforcement reports list 12 drug recall entries naming minoxidil from 2013 to 2023-02-01. 12 of them are for compounded or other unlisted products and 0 for products FDA lists under a label. The most common stated reason was potency out of specification (5 of 12).
| Measure | Value | Note |
|---|---|---|
| Recall entries on record | 12 | |
| For products FDA lists under an approved or registered label | 0 | |
| For compounded or other unlisted products | 12 | matched by the name in the product description |
| Class I (most serious) | 1 | |
| Class II | 11 | |
| Class III | 0 | |
| Most recent recall reported | 2023-02-01 | |
| Most common stated reason | potency out of specification | 5 of 12 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 minoxidil 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 minoxidil
ClinicalTrials.gov lists 112 registered studies that name minoxidil as an intervention as of 2026-11-11. Of these, 13 are recruiting, 52 are completed and 22 are phase 3 studies.
| Measure | Value |
|---|---|
| Registered studies | 112 |
| Recruiting now | 13 |
| Not yet recruiting | 12 |
| Completed | 52 |
| Terminated, withdrawn or suspended | 6 |
| Phase 3 (including phase 2/3) | 22 |
| Phase 2 (including phase 1/2) | 28 |
| Phase 1 | 12 |
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 minoxidil, 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 Minoxidil
- Oral Minoxidil Compounded Equivalent: How to Access Low-Dose Minoxidil in 2026
- Oral Minoxidil HSA/FSA Eligibility and Submission: What You Need to Know in 2026
- Oral Minoxidil Medicaid Coverage by State Tier (2026 Guide)
- Oral Minoxidil Medicare Part D Coverage: What's Covered, What's Not, and How to Pay Less
- Oral Minoxidil VA Coverage Pathway: How Veterans Can Access Low-Dose Minoxidil
- Oral Minoxidil Monitoring for Adults (30-49): Lab Work, Heart Checks, and Follow-Up Schedules