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Androgel (TESTOSTERONE)
Androgel (testosterone) is a small molecule androgen that targets the androgen receptor. Originally developed by Actient Pharms and currently owned by Besins Healthcare, it was FDA-approved in 1972 for various indications including hypogonadism, delayed puberty, and hormone receptor-positive breast cancer. Androgel is available as a generic medication from multiple manufacturers. Key safety considerations include the potential for increased risk of cardiovascular events and prostate cancer. The commercial status of Androgel is generic, with 15 generic manufacturers available.
At a glance
| Generic name | TESTOSTERONE |
|---|---|
| Sponsor | Besins Hlthcare |
| Drug class | Androgen [EPC] |
| Target | Androgen receptor |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 1972 |
Approved indications
- Primary Hypogonadism
- Hypogonadotropic Hypogonadism
- Stimulation of Puberty
Common side effects
- Application Site Reactions
- Benign Prostatic Hyperplasia
- Blood Pressure Increased
- Headache
- Hematocrit/hemoglobin Increased
- Hot Flushes
- Insomnia
- Lacrimation Increased
- Mood Swings
- Smell Disorder
- Spontaneous Penile Erection
- Taste Disorder
Drug interactions
- warfarin
Key clinical trials
- Clinical Evaluation of Subcutaneous Testosterone Implants in Men With Symptomatic Hypogonadism (PHASE2)
- Oxandrolone Multiligament Knee (PHASE4)
- Acute Vitamin D Supplementation on Testosterone in Females (NA)
- Enzalutamide and PDS01ADC in PET Positive Recurrent Prostate Cancer (pprPC) Without Testosterone Lowering Therapy (PHASE2)
- Comparison of the Concentration of Estrogen and Testosterone Ratio in Male Patients With Cirrhosis and Hypotension
- [18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone Pet Imaging in Patients With Progressive Prostate Cancer (NA)
- Body Composition Assessment in Transgender Population.
- PREDICTORS OF TESTOSTERONE DECLINE IN MIDDLE-AGED MEN
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Androgel CI brief — competitive landscape report
- Androgel updates RSS · CI watch RSS
- Besins Hlthcare portfolio CI