Public record

Minoxidil: the public record

9 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.

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.

FDA approval history for minoxidil: the figures
MeasureValueNote
Earliest FDA approval on file1979-10-18
Applications with an approval on file37
New drug applications (NDA)4
Generic applications (ANDA)33
Approved supplements195label, manufacturing and efficacy changes
Most recent supplement approval2026-09-04
Sponsoring companies24

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 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.

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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.

Patents and generic approvals for minoxidil: the figures
MeasureValueNote
Brand-name applications (NDA)4
Approved generic applications (ANDA)33first approved 1987-03-03
Companies with a generic not marked discontinued11
Listed patents not yet expired0
Earliest approval date on filebefore 1982
Products not marked discontinued30 of 49

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 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.

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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.

Medicare Part D claims for minoxidil by age group: the figures
MeasureValueNote
All Part D claims, 2024603,284
Claims for enrollees aged 65 and over516,008
Claims for enrollees under 6587,276mostly people who qualify through disability
Share of claims for enrollees aged 65 and over85.5%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 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.

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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.

Medicare Part D claims for minoxidil by state: the figures
MeasureValueNote
All states and territories, 2024603,254 claims
States and territories with reported claims55
California75,311 claims$1.1M gross drug cost
Texas51,031 claims$794,299 gross drug cost
Florida43,341 claims$666,498 gross drug cost
New York40,909 claims$530,939 gross drug cost
Georgia21,295 claims$298,941 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 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.

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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.

Medicare Part D spending on minoxidil: the figures
MeasureValue
Total spending, 2024$8.8M
Total spending, 2023$9.0M
Change in spending, 2023 to 2024-1.8%
Claims (prescription fills), 2024603,619
Average spending per claim, 2024$14.60

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 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.

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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.

Medicaid prescriptions for minoxidil by state: the figures
MeasureValueNote
Prescriptions paid by Medicaid, 2025204,032
Total reimbursed before rebates, 2025$2.5M
States and territories reporting52with at least one count CMS did not suppress
California44,971 prescriptions$772,729 reimbursed
New York24,741 prescriptions$366,726 reimbursed
Michigan9,535 prescriptions$59,370 reimbursed
Ohio7,973 prescriptions$100,270 reimbursed
Pennsylvania7,257 prescriptions$77,212 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 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.

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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.

Pharmacy acquisition cost (NADAC) for minoxidil: the figures
MeasureValueNote
MINOXIDIL 10 MG TABLET$0.1506 per unit12 months earlier $0.2034 (-26.0%)
MINOXIDIL 2.5 MG TABLET$0.0969 per unit12 months earlier $0.0970 (-0.1%)
MINOXIDIL 2% SOLUTION$0.2415 per mLno price on file 12 months earlier
MINOXIDIL 5% SOLUTION$0.2705 per mLno price on file 12 months earlier
MINOXIDIL FOR MEN 5% FOAM$0.2244 per gramno price on file 12 months earlier
MINOXIDIL FOR WOMEN 5% FOAM$0.2244 per gramno 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 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.

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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).

FDA drug recalls naming minoxidil: the figures
MeasureValueNote
Recall entries on record12
For products FDA lists under an approved or registered label0
For compounded or other unlisted products12matched by the name in the product description
Class I (most serious)1
Class II11
Class III0
Most recent recall reported2023-02-01
Most common stated reasonpotency out of specification5 of 12 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 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.

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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.

Registered clinical studies of minoxidil: the figures
MeasureValue
Registered studies112
Recruiting now13
Not yet recruiting12
Completed52
Terminated, withdrawn or suspended6
Phase 3 (including phase 2/3)22
Phase 2 (including phase 1/2)28
Phase 112

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 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.

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