AXIRON
LOE ApproachingNDATRANSDERMALSOLUTION, METERED
Approved
Nov 2010
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
1
Data completeness
4/8 — Partial
AXIRON by Eli Lilly and Company is androgens, including testosterone and dihydrotestosterone (dht), are responsible for the normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. First approved in 2010.
Drug data last refreshed 21h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AXIRON is a metered-dose transdermal testosterone solution approved for male hypogonadism, a condition characterized by insufficient testosterone secretion. It works by delivering androgens that restore normal male sexual function, secondary sex characteristics, and overall energy. The product addresses both primary hypogonadism (gonadal defects) and secondary hypogonadism (hypothalamic-pituitary failure).
LOE Approaching1.4 years to LOE
With LOE approaching in late 2027, the brand team faces contraction; focus will shift to defending market share against generics and optimizing existing market penetration.
Mechanism of Action
androgens, including testosterone and dihydrotestosterone (DHT), are responsible for the normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. These effects include the growth and maturation of prostate, seminal vesicles, penis and scrotum; the…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (1)
A Study of Axiron® in Healthy Participants
Started Dec 2013
12 enrolled
Healthy Volunteers
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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.