NDATRANSDERMALGEL
Approved
Apr 2011
Lifecycle
LOE Approaching
Competitive Pressure
25/100
Clinical Trials
20
Data completeness
7/8 — Comprehensive
ANDROGEL (testosterone) by Besins Healthcare is androgen receptor agonists [moa]. Approved for hypogonadism. First approved in 2011.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ANDROGEL is a transdermal gel formulation of testosterone, an androgen receptor agonist approved in 2011 for hypogonadism and multiple other indications including muscle wasting, sexual dysfunction, and metabolic disorders. It works by binding to androgen receptors to restore testosterone levels and promote anabolic effects across tissues.
$3.0MPart D
LOE Approaching5mo to LOEProduct is in final 6 months before loss of exclusivity; commercial team is likely focused on transition planning and generic mitigation rather than growth initiatives.
Mechanism of Action
Androgen Receptor Agonists
Pharmacologic Class:
Androgen
Indications (1)
Clinical Trials (20)
Testosterone Treatment for Erectile Dysfunction and Multiple Sclerosis
Started Jun 2026
20 enrolled
Multiple SclerosisErectile DysfunctionTestosterone Deficiency
Supraphysiologic Testosterone Priming Induces Darolutamide Extended Response
Started Mar 2026
60 enrolled
Metastatic Castration-resistant Prostate Cancer
Testosterone Deficiency and Endothelial Dysfunction After Spinal Cord Injury
Started Jul 2025
48 enrolled
Spinal Cord InjuriesEndothelial DysfunctionTestosterone Deficiency
52 Week Study + 24-Month Long-Term Extension of Safety, PK, & Efficacy of XYOSTED® for Testosterone Replacement in Male Adolescents With Hypogonadism
Started Mar 2025
100 enrolled
Hypogonadism, Male
Puberty, Testosterone, and Brain Development
Started Dec 2024
100 enrolled
Gender IdentityGender Dysphoria in Adolescents and AdultsHeadache+1 more
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.