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]. First approved in 2011.
Drug data last refreshed 3h ago · AI intelligence enriched 3d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ANDROGEL is a transdermal testosterone gel approved in 2011 for hormone replacement in hypogonadal men. It works as an androgen receptor agonist to restore physiological testosterone levels. The product is administered topically, allowing steady-state hormone delivery without daily injections.
$0.003BPart D
LOE ApproachingDeclining
4mo to LOENearing loss of exclusivity in October 2026; brand team focus shifting toward defensive strategies and managed decline as generic/biosimilar competition accelerates.
Mechanism of Action
Androgen Receptor Agonists
Pharmacologic Class:
Androgen
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
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.