Public record

Testosterone cypionate: the public record

11 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 testosterone cypionate

The FDA label read for testosterone cypionate (AZMIRO, application NDA216318) was last revised on 2025-07-25. It carries no boxed warning. Of the 4 population sections checked, 4 are present: pregnancy, lactation, pediatric use, geriatric use.

FDA label facts for testosterone cypionate: the figures
MeasureValueNote
Label revision date2025-07-25
Label readAZMIRONDA216318, 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 testosterone cypionate 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 testosterone cypionate

The earliest FDA approval on file for a testosterone cypionate product is 1978-06-23. Drugs@FDA lists 19 applications for it and 102 approved supplements, the most recent on 2025-07-28.

FDA approval history for testosterone cypionate: the figures
MeasureValueNote
Earliest FDA approval on file1978-06-23
Applications with an approval on file19
New drug applications (NDA)1
Generic applications (ANDA)18
Approved supplements102label, manufacturing and efficacy changes
Most recent supplement approval2025-07-28
Sponsoring companies17

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 testosterone cypionate 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 testosterone cypionate

The FDA Orange Book lists 16 approved generic applications for testosterone cypionate, the first approved on 2005-01-31. 3 listed patents on specific brand products have not yet expired, the last on 2039-03-25; generics of other versions are already approved.

Patents and generic approvals for testosterone cypionate: the figures
MeasureValueNote
Brand-name applications (NDA)1
Approved generic applications (ANDA)16first approved 2005-01-31
Companies with a generic not marked discontinued10
Listed patents not yet expired3
Latest listed patent expiry2039-03-25on any product; may cover only one brand formulation
Earliest approval date on filebefore 1982
Products not marked discontinued15 of 26

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 testosterone cypionate 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 testosterone cypionate by age group

Of 1,120,868 Medicare Part D claims for testosterone cypionate in 2024, 828,574 (73.9%) were for enrollees aged 65 and over and 292,294 were for enrollees under 65.

Medicare Part D claims for testosterone cypionate by age group: the figures
MeasureValueNote
All Part D claims, 20241,120,868
Claims for enrollees aged 65 and over828,574
Claims for enrollees under 65292,294mostly people who qualify through disability
Share of claims for enrollees aged 65 and over73.9%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 testosterone cypionate 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 testosterone cypionate by state

Florida had the most Medicare Part D claims for testosterone cypionate in 2024 (125,019), followed by Texas (103,782) and California (80,239). Prescribers in 58 states and territories wrote 1,120,842 claims in all.

Medicare Part D claims for testosterone cypionate by state: the figures
MeasureValueNote
All states and territories, 20241,120,842 claims
States and territories with reported claims58
Florida125,019 claims$5.1M gross drug cost
Texas103,782 claims$4.5M gross drug cost
California80,239 claims$3.3M gross drug cost
Georgia47,615 claims$1.7M gross drug cost
North Carolina46,079 claims$1.6M 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 testosterone cypionate 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 testosterone cypionate

Medicare Part D spending on testosterone cypionate products was $41.6M in 2024 across 1,121,071 claims, compared with $39.0M in 2023 (+6.7%). Average spending per claim was $37.06, before rebates.

Medicare Part D spending on testosterone cypionate: the figures
MeasureValueNote
Total spending, 2024$41.6M
Total spending, 2023$39.0M
Change in spending, 2023 to 2024+6.7%
Claims (prescription fills), 20241,121,071
Average spending per claim, 2024$37.06
Testosterone Cypionate: spending, 2024$41.4M1,118,253 claims
Depo-Testosterone: spending, 2024$162,3672,818 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 testosterone cypionate product in Part D (Testosterone Cypionate, Depo-Testosterone), 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 testosterone cypionate by state

State Medicaid programmes paid for 583,527 testosterone cypionate prescriptions in 2025, with $21.0M reimbursed before rebates. California reported the most (83,353), followed by Oregon (36,422) and Kentucky (33,704); 52 states and territories reported any.

Medicaid prescriptions for testosterone cypionate by state: the figures
MeasureValueNote
Prescriptions paid by Medicaid, 2025583,527
Total reimbursed before rebates, 2025$21.0M
States and territories reporting52with at least one count CMS did not suppress
California83,353 prescriptions$3.9M reimbursed
Oregon36,422 prescriptions$988,680 reimbursed
Kentucky33,704 prescriptions$1.1M reimbursed
New York31,492 prescriptions$1.3M reimbursed
Michigan29,878 prescriptions$825,596 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 testosterone cypionate 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 testosterone cypionate

Retail pharmacies paid an average of $11.01 per mL for TESTOSTERONE CYP 200 MG/ML as of 2026-11-11, compared with $11.76 twelve months earlier (-6.4%). This is a pharmacy purchase cost, not a patient price.

Pharmacy acquisition cost (NADAC) for testosterone cypionate: the figures
MeasureValueNote
TESTOSTERONE CYP 200 MG/ML$11.01 per mL12 months earlier $11.76 (-6.4%)
TESTOSTERONE CYP 2,000 MG/10 ML$2.42 per mL12 months earlier $3.42 (-29.1%)
TESTOSTERONE CYP 1,000 MG/10 ML$4.32 per mL12 months earlier $4.99 (-13.4%)

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 testosterone cypionate 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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Adverse event reports

Most reported events in FDA adverse event reports for testosterone cypionate

Through 2026-10-28, FDA had received 8,833 adverse event reports for testosterone cypionate, 5,064 of them marked serious by the reporter. The symptom terms named most often were myocardial infarction (953), cerebrovascular accident (685) and deep vein thrombosis (624).

Most reported events in FDA adverse event reports for testosterone cypionate: the figures
MeasureValueNote
All reports received8,833
Reports the reporter marked serious5,064death, hospitalisation, disability or similar outcome
Myocardial infarction953 reports
Cerebrovascular accident685 reports
Deep vein thrombosis624 reports
Pulmonary embolism572 reports
Pain474 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 testosterone cypionate 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 testosterone cypionate

FDA enforcement reports list 161 drug recall entries naming testosterone cypionate from 2012 to 2026-10-28. 147 of them are for compounded or other unlisted products and 14 for products FDA lists under a label. The most common stated reason was lack of sterility assurance (130 of 161).

FDA drug recalls naming testosterone cypionate: the figures
MeasureValueNote
Recall entries on record161
For products FDA lists under an approved or registered label14
For compounded or other unlisted products147matched by the name in the product description
Class I (most serious)1
Class II157
Class III3
Most recent recall reported2026-10-28
Most common stated reasonlack of sterility assurance130 of 161 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 testosterone cypionate 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 testosterone cypionate

ClinicalTrials.gov lists 55 registered studies that name testosterone cypionate as an intervention as of 2026-11-11. Of these, 11 are recruiting, 25 are completed and 8 are phase 3 studies.

Registered clinical studies of testosterone cypionate: the figures
MeasureValue
Registered studies55
Recruiting now11
Not yet recruiting5
Completed25
Terminated, withdrawn or suspended8
Phase 3 (including phase 2/3)8
Phase 2 (including phase 1/2)24
Phase 16

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 testosterone cypionate, 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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