CLINICAL TRIALS PROFILE FOR DEPO-TESTOSTERONE

505(b)(2) Clinical Trials for DEPO-TESTOSTERONE

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT00626431 ↗	A Study of Leuprolide to Treat Prostate Cancer	Completed	Abbott	Phase 3	2008-02-01	To assess the efficacy and safety of 2 new formulations of leuprolide acetate 45 mg 6-month depot, Formulation A or Formulation B, for the treatment of patients with prostate cancer. A formulation will be deemed successful if the percentage of subjects with suppression of testosterone to
New Formulation	NCT04060043 ↗	Pilot Study to Evaluate the Effects of a Generic Goserelin Acetate in Patients With Prostate Cancer	Completed	Peptigroupe Inc	Early Phase 1	2017-02-21	This open-label study is designed to obtain preliminary data on the efficacy of a new depot formulation of goserelin, Pepti 10.8mg, in ambulatory patients with carcinoma of the prostate who, in the opinion of the Investigator, is a candidate for androgen deprivation therapy, after a single injection. Secondarily, it is designed to assess the pharmacokinetics, safety profile and PSA response of this new formulation.
New Formulation	NCT04060043 ↗	Pilot Study to Evaluate the Effects of a Generic Goserelin Acetate in Patients With Prostate Cancer	Completed	Peptigroupe Inc.	Early Phase 1	2017-02-21	This open-label study is designed to obtain preliminary data on the efficacy of a new depot formulation of goserelin, Pepti 10.8mg, in ambulatory patients with carcinoma of the prostate who, in the opinion of the Investigator, is a candidate for androgen deprivation therapy, after a single injection. Secondarily, it is designed to assess the pharmacokinetics, safety profile and PSA response of this new formulation.
New Formulation	NCT04060043 ↗	Pilot Study to Evaluate the Effects of a Generic Goserelin Acetate in Patients With Prostate Cancer	Completed	CMX Research	Early Phase 1	2017-02-21	This open-label study is designed to obtain preliminary data on the efficacy of a new depot formulation of goserelin, Pepti 10.8mg, in ambulatory patients with carcinoma of the prostate who, in the opinion of the Investigator, is a candidate for androgen deprivation therapy, after a single injection. Secondarily, it is designed to assess the pharmacokinetics, safety profile and PSA response of this new formulation.
New Formulation	NCT04887506 ↗	TAVT-45 (Abiraterone Acetate) Granules in Patients With Prostate Cancer	Recruiting	Tavanta Therapeutics	Phase 3	2021-04-14	The purpose of this study is to investigate the safety and efficacy of a new formulation of an existing drug product called TAVT-45 in patients with metastatic prostate cancer.

All Clinical Trials for DEPO-TESTOSTERONE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000175 ↗	The Effects of Sex Hormones on Cognition and Mood in Older Adults	Terminated	National Institute on Aging (NIA)	N/A	1969-12-31	This study is investigating the effects of hormone replacement therapy on memory, mental abilities and mood in older adults aged 65-90. During the nine month long study, men will take testosterone for three months and women will take estrogen for three months. At four points during the study (once every three months), participants will complete a test battery and have blood drawn.
NCT00000177 ↗	Estrogen Hormone Protocol	Completed	National Institute on Aging (NIA)	Phase 3	1995-10-01	Estrogen is a hormone that is dominant in the female reproductive system. In women, most estrogen is produced by the ovaries. Men produce estrogen by converting testosterone into estrogen. Because this hormone also has many beneficial effects on brain cells, it currently is being studied as a treatment for Alzheimer's disease. The enzyme that forms the neurotransmitter acetylcholine is promoted in the presence of estrogen. Several very small clinical studies have demonstrated improvement in cognitive function and mood measures in women with Alzheimer's disease who take estrogen.
NCT00000854 ↗	A Study to Evaluate the Effect of Nandrolone Decanoate in Women With HIV-Associated Weight Loss	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	1969-12-31	The purpose of this study is to see if giving nandrolone decanoate (a hormonal drug) will cause weight gain in HIV-positive women who have HIV-associated weight loss (wasting). Wasting has become an AIDS-defining condition. In the past, most studies that examined wasting treatments were limited to men. However, it appears that wasting in HIV-positive men is linked to levels of testosterone (a hormone which affects men's bodies more than women's). This study has been designed for women only, in order to best treat wasting in HIV-positive women.
NCT00001079 ↗	A Study of Megestrol Acetate Alone or in Combination With Testosterone Enanthate Drug in the Treatment of HIV-Associated Weight Loss	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	1969-12-31	To test the hypothesis that the predominant accrual of fat rather than lean body mass (LBM) that occurs during treatment of HIV-associated wasting with megestrol acetate may be improved by treatment with megestrol acetate and testosterone enanthate in combination. Body wasting is an increasingly frequent AIDS-defining condition in individuals infected with HIV. Increasing caloric intake fails to consistently restore lean tissue patients with HIV associated weight loss. Megestrol acetate has been shown to stimulate appetite and weight gain in subjects with cancer and in those with HIV associated weight loss. However, the weight gained during treatment with megestrol acetate was predominantly or exclusively fat. An important factor is the preferential increase in body fat seen in both of these studies may have been due to hypogonadism that occurs as a result of treatment with megestrol acetate, a progestational agent. Hypogonadism is associated with an increase in body fat and a decrease in LBM. Concomitant testosterone replacement should substantially increase the amount of LBM accrued during megestrol acetate therapy. This study will determine whether anabolic potential can be realized when caloric intake is increased in the absence of concomitant hypogonadism.
NCT00001202 ↗	Treatment of Boys With Precocious Puberty	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 2	1985-01-01	This study is a continuation of two previous studies conducted at the NIH. The first study , "Treatment of True Precocious Puberty with a Long-Acting Lutenizing Hormone Releasing Hormone Analog (D-Trp(6)-Pro(9)-Net-LHRH)" had less than optimal results. Some patients, all of whom were diagnosed with familial isosexual precocious puberty, had an inadequate response to the medication and were observed to have high levels of testosterone, advanced bone aging, and other complications of the disease. As a result these patients were enrolled in a second study In the second study, "Spironolactone Treatment for Boys with Familial Isosexual Precocious Puberty", - the patients received another medication, spironolactone (Aldactone). The drug blocked the effects of testosterone, -but bone age advancement did not improve. Some patients began experiencing gynecomastia (an abnormal growth of the male breasts). Researchers believe these may be the effects of elevated levels of estrodiol (a form of the female hormone, estrogen). In the present study, testolactone is added to the drug regimen to block the production of estrogen. The study therefore uses spironolactone to prevent the action of the male hormones (androgen) and testolactone to block the production of female hormones (estrogen). Deslorelin, an LHRH analog which works by turning off true (central) puberty, is added to the drug regimen once true puberty begins. This is because it is know that boys with familial male precocious puberty go into true puberty too early (despite treatment with spironolactone and testolactone), and when that happens, the spironolactone and testolactone are no longer as effective. The goal of the treatment is to delay sexual development until a more appropriate age and prevent short adult stature (height).

Clinical Trial Conditions for DEPO-TESTOSTERONE

Condition Name

Condition Name for DEPO-TESTOSTERONE
Intervention	Trials
Prostate Cancer	195
Hypogonadism	137
Polycystic Ovary Syndrome	55
Hypogonadism, Male	33

Condition MeSH

Condition MeSH for DEPO-TESTOSTERONE
Intervention	Trials
Prostatic Neoplasms	324
Hypogonadism	219
Polycystic Ovary Syndrome	74
Syndrome	54

Clinical Trial Locations for DEPO-TESTOSTERONE

Trials by Country

Trials by Country for DEPO-TESTOSTERONE
Location	Trials
Germany	58
Brazil	55
Australia	47
Spain	45
Italy	40

Trials by US State

Trials by US State for DEPO-TESTOSTERONE
Location	Trials
California	188
Texas	165
New York	146
Maryland	123
Florida	120

Clinical Trial Progress for DEPO-TESTOSTERONE

Clinical Trial Phase

Clinical Trial Phase for DEPO-TESTOSTERONE
Clinical Trial Phase	Trials
PHASE4	16
PHASE3	17
PHASE2	29

Clinical Trial Status

Clinical Trial Status for DEPO-TESTOSTERONE
Clinical Trial Phase	Trials
Completed	570
Recruiting	195
Terminated	75

Clinical Trial Sponsors for DEPO-TESTOSTERONE

Sponsor Name

Sponsor Name for DEPO-TESTOSTERONE
Sponsor	Trials
National Cancer Institute (NCI)	91
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	54
University of Washington	39

Sponsor Type

Sponsor Type for DEPO-TESTOSTERONE
Sponsor	Trials
Other	1260
Industry	481
NIH	237

Last updated: May 21, 2026

DEPO-TESTOSTERONE clinical trials update, market analysis and exclusivity outlook

Executive summary: DEPO-TESTOSTERONE (testosterone cypionate) is a long-established testosterone replacement therapy (TRT) branded drug with no meaningful ongoing clinical pipeline typical of a modern development program. Commercial dynamics are driven primarily by (1) generic competition and (2) the product’s ability to maintain supply, pricing, and payer coverage rather than late-stage innovation. For exclusivity and patent strategy, the actionable focus is the remaining U.S. Orange Book-listed drug-product and method-of-use intellectual property that could constrain generic entry, plus any product-specific barriers tied to manufacturing, labeling, and device/container configuration.

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What is DEPO-TESTOSTERONE (testosterone cypionate) and what clinical-trial activity exists?

Featured-snippet answer: DEPO-TESTOSTERONE is an injectable testosterone ester indicated for conditions associated with a deficiency or absence of endogenous testosterone. Clinical evidence for TRT is not tied to a single brand’s late-stage trials; much of the evidentiary base is therapeutic-class literature and earlier development work for testosterone esters. Current “updates” for branded DEPO-TESTOSTERONE are usually supply, labeling, and manufacturing changes rather than new pivotal studies.

Core therapeutic positioning

• Drug class: Androgen receptor agonists (TRT).
• Active ingredient: Testosterone cypionate.
• Dosage form: Intramuscular injection (suspension/solution depending on label and manufacturer presentation).
• Typical use setting: Endocrinology, urology, primary care with testosterone-deficiency workup.

Why clinical-trial headlines are limited for this product

• Testosterone cypionate is older, and the branded product is not commonly the sponsor for large, new registrational trials.
• The market is shaped by generic availability and supply continuity, which rarely drives “clinical trials updates” from a branded standpoint.

Clinical-trials update framework used for market/entry decisions

Even when no brand-sponsored pivotal trial is active, competitors and investors track:

• Labeling expansions that change payer adoption (age indications, diagnostic criteria, safety communications).
• Safety surveillance outcomes relevant to TRT risk management.
• Bioequivalence or manufacturing tech-transfer programs that enable generic or authorized versions.

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What patents protect DEPO-TESTOSTERONE and how strong is the patent estate for generics?

Featured-snippet answer: For testosterone cypionate products, U.S. patent coverage is generally concentrated in older formulation, manufacturing, and method-of-use patents. In many TRT ester categories, most meaningful composition/formulation exclusivities have expired, leaving generics protected mainly by remaining Orange Book listings that are time-bound to specific drug products and claims.

Patent estate mapping approach (high-utility for licensing and Paragraph IV risk)

For DEPO-TESTOSTERONE, the practical patent questions are:

• Are there any still-active Orange Book patents tied to the exact drug product (strength, dosage form, and holder)?
• Do any active patents cover:
  • Method of use (TRT indication and regimen)
  • Manufacturing processes
  • Formulation (carrier, stabilization, particle/crystal size constraints)
  • Container closure or delivery configuration (less common for injectables, but can be product-specific)

Market impact of weak vs. strong patent coverage

• Weak remaining patent coverage: Generic entry tends to be fast and pricing pressure broad.
• Moderate coverage: Entry can still occur but may require design-around, alternate manufacturing routes, or labeling carve-outs.
• Strong coverage (less typical for older testosterone esters): Entry delays, licensing, and settlement patterns become material.

Actionable lens: In TRT injectables, the most litigated constraints are often product-specific Orange Book patents rather than broad therapeutic-class patents.

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When does DEPO-TESTOSTERONE lose exclusivity in the U.S.?

Featured-snippet answer: For legacy testosterone ester brands, exclusivity typically centers on expired composition/formulation claims and may only persist via remaining Orange Book drug-product patents or, depending on the product history, data exclusivity windows that do not survive generics long-term.

Exclusivity timeline categories to track

• Patent expiration (including any pediatric-related adjustments if applicable)
• Orange Book drug-product patent expiration
• Regulatory exclusivity
  • New chemical entity exclusivity (generally not applicable to testosterone cypionate)
  • 5-year/3-year exclusivity tied to new clinical studies or new indications (rare for legacy TRT brands unless label changes were supported by new studies)

Practical outcome

• TRT injectables usually transition to competitive pricing once generic supply is stable.
• Any remaining exclusivity typically affects:
  • Initial authorized generic timing
  • First-wave ANDA approvals versus subsequent entries

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What is the Orange Book status of DEPO-TESTOSTERONE?

Featured-snippet answer: Orange Book status must be read at the drug-product level, including strength and dosage form. For legacy injectables like testosterone cypionate, the Orange Book list historically includes one or more drug-product patents, with many claims long expired. The current status determines whether any ANDA applicants face Paragraph IV leverage.

Why Orange Book status matters

• It determines whether Paragraph IV certifications are possible.
• It shapes:
  • Settlement probability
  • Launch timing risk for generics
  • Licensing negotiating position for the brand

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Are there any Paragraph IV challenges or ANDA litigation involving DEPO-TESTOSTERONE?

Featured-snippet answer: TRT ester categories generally experience periodic ANDA litigation around remaining Orange Book patents, but the branded value-at-risk for a long-since-mature injectable depends on what patents remain unexpired and whether generic manufacturers are willing to challenge.

How to interpret litigation risk for pricing and launch

• If no active Orange Book patents: Paragraph IV leverage is reduced; generics enter based on formulation and bioequivalence.
• If there are active patents with enforceable claims: expect a higher chance of:
  • Dispute-driven delays
  • Consent judgments and settlement agreements
  • Temporary market allocation dynamics

Commercial consequence

Even when a challenge exists, what matters is whether it blocks:

• FDA approval date
• 180-day exclusivity triggering
• Actual commercial launch (supply readiness)

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What formulations are protected for DEPO-TESTOSTERONE (and do they restrict generic versions)?

Featured-snippet answer: For injectable testosterone esters, formulation protection typically covers composition and/or stabilization features rather than the core pharmacological claim. Generic entry is usually enabled if competitors can replicate bioequivalence without infringing formulation claims that remain active.

Formulation-related barriers that can persist

• Stabilizers, solubilizers, and emulsifying system definitions
• Sterility assurance methods tied to specific manufacturing windows
• Particle size or suspension characteristics (if applicable to the specific product presentation)

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How does DEPO-TESTOSTERONE compare with other TRT injectables (cypionate vs. enanthate vs. blends) on competitive risk?

Featured-snippet answer: Competitive risk is driven by:

• Generic availability and pricing
• Supply reliability
• Payer preference by brand/formulary placement
• Formulation/container and perceived tolerability

Market comparator set

• Testosterone cypionate injectables (same active ingredient)
• Testosterone enanthate injectables (different ester, therapeutic equivalence in TRT practice)
• Testosterone undecanoate (long-acting, different administration pattern)
• TRT gels/patches (non-injectable substitution patterns)

Where brand injectable typically loses

• Once multiple ANDA versions exist, prescribers and payers select based on:
  • net price
  • availability
  • reimbursement policy
• Patent leverage from a single brand becomes less relevant if competitors have equivalent offerings.

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What biosimilar risk exists for DEPO-TESTOSTERONE?

Featured-snippet answer: No biosimilar risk applies. DEPO-TESTOSTERONE is a small-molecule drug, so the biosimilar pathway does not apply.

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Regulatory status: what FDA pathway governs testosterone cypionate generics and what does it mean for launch?

Featured-snippet answer: Generic testosterone cypionate is approved via the ANDA pathway when the reference listed drug is established and bioequivalence is demonstrated. Launch timing depends on:

• Paragraph IV outcomes (if any)
• FDA approval timing
• 180-day exclusivity (if triggered)
• manufacturing readiness and labeling negotiations

Key operational constraints

• Sterile injectable production complexity and batch release lead times
• Supply chain continuity for raw materials and filtration/sterility processes

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Commercial market analysis and projection for DEPO-TESTOSTERONE (U.S.)

Executive summary: For legacy TRT injectables, market growth is constrained by:

• saturation of diagnosed populations
• generic price erosion
• substitution to alternative TRT modalities depending on payer and patient preference (gels, patches, long-acting injectables) Market value is more sensitive to pricing and supply than to incremental adoption driven by new clinical trials.

Market drivers

1. Diagnosis and treatment rates for hypogonadism
2. Payer coverage policy and prior authorization behavior
3. Provider prescribing norms (injection vs. non-injection)
4. Intermittent supply constraints
5. Seasonal and demographic factors affecting TRT utilization

Market headwinds

• Generic substitution reduces net unit value.
• Increased scrutiny and guideline updates can shift initiation criteria.
• Potential ongoing labeling and safety communications can affect adoption.

Market projection logic (what moves numbers)

• Net sales typically follow a pattern:
  • early brand premium phase
  • then sustained erosion post-generic entry
  • occasional stabilization if supply shortages temporarily reduce generic availability

Projection ranges (structure, not speculative precision)

A defensible projection for a mature injectable like DEPO-TESTOSTERONE is built around:

• expected generic market share expansion
• price-per-unit declines tied to competitive entries
• the share of total TRT patients remaining on injectable formulations

Without current, product-specific sales/revenue and pricing data, the only investable projection structure is:

• Scenario 1 (continued generic competition): stable-to-declining branded unit share with pricing pressure
• Scenario 2 (supply disruption or manufacturing consolidation): temporary uplift in brand or limited generic pricing power
• Scenario 3 (regulatory or litigation delay): short-term sales protection until patent/ANDA events resolve

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Key litigation and settlement patterns that typically affect TRT injectable launches

Featured-snippet answer: When Orange Book patents remain active for legacy testosterone injectables, the dominant launch-risk channels are Paragraph IV certifications and the resulting settlement agreements that can delay approval or entry. The practical business impact is measured in months-to-1-year scale for initial launch events, then broader market pricing equalization.

What settlements usually do

• Fix a calendar for a design-around entry
• Define labeling carve-outs to avoid method-of-use claims
• Allocate 180-day exclusivity rights or waive them

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Commercial strategy: where DEPO-TESTOSTERONE brand holders still compete successfully

Featured-snippet answer: In mature TRT injectables, brand differentiation is operational and payer-driven: supply reliability, formulary positioning, and contract pricing. Clinical-trial differentiation is usually not the lever.

Highest-leverage levers

• Maintain consistent availability (avoid backorders)
• Secure payer contracts that prefer or reimburse specific label strengths
• Improve distribution coverage and reduce pack-size friction
• Defend any remaining Orange Book patents with credible enforcement if they exist

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Key Takeaways

• DEPO-TESTOSTERONE is a mature TRT injectable with limited sponsor-driven clinical trial momentum typical of legacy small-molecule assets.
• The business-critical “update” is not trial readouts; it is patent/Orange Book status and ANDA/Paragraph IV litigation risk for specific drug-product strengths.
• Market outcomes depend primarily on generic pricing, supply continuity, and payer formulary behavior rather than new clinical evidence.
• No biosimilar pathway risk applies because testosterone cypionate is a small molecule.

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FAQs

1. How do ANDA approvals for testosterone cypionate typically determine generic launch timing?
2. What Orange Book drug-product patents matter most for delaying ANDA entry for legacy injectable testosterone?
3. Do TRT injectables see substitution shifts toward gels/long-acting injectables that reduce injectable brand sales?
4. How do supply disruptions in sterile injectables typically affect branded vs. generic net pricing?
5. What evidence-based guidelines most influence prescribing volume for testosterone replacement therapy in hypogonadism?

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References (APA)

No sources were cited.