NDATRANSDERMALGEL
Approved
Apr 2011
Lifecycle
Post-LOE
Competitive Pressure
35/100
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 17h ago · AI intelligence enriched 1mo 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 hormone replacement therapy. It delivers testosterone through the skin to treat conditions associated with low testosterone levels. The product works by binding to androgen receptors to restore physiological testosterone levels in deficient patients.
$0.003BPart D
LOE ApproachingDeclining
Post-LOEProduct approaching loss of exclusivity in October 2026 with competitive pressure index of 25, signaling contracted team focus and defensive positioning rather than expansion.
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 Therapy With or Without Finasteride After Spinal Cord Injury: TRT-SCI Trial
Started Oct 2027
300 enrolled
Spinal Cord InjurySpinal Cord InjuriesInjuries, Spinal Cord+11 more
Testosterone Treatment for Erectile Dysfunction and Multiple Sclerosis
Started Jun 2026
0Multiple 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
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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.