NDAORALCAPSULE
Approved
Jun 2010
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
4
Data completeness
6/8 — Strong
JALYN (dutasteride and tamsulosin hydrochloride) by Viatris (2) is 5-alpha reductase inhibitors [moa]. Approved for symptomatic benign prostatic hyperplasia (bph) in men with an enlarged prostate, symptomatic bph in men with an enlarged prostate. First approved in 2010.
Drug data last refreshed 3d ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
JALYN is a fixed-dose combination oral capsule containing dutasteride (a 5-alpha reductase inhibitor) and tamsulosin hydrochloride (an alpha-1A adrenergic antagonist) approved for symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate. The dual mechanism addresses both the underlying cause of BPH (androgen-driven prostate growth via dutasteride) and acute urinary symptoms (via tamsulosin's relaxant effect on smooth muscle). This combination therapy provides enhanced efficacy over monotherapy in reducing lower urinary tract symptoms and risk of acute urinary retention.
$0.001BPart D
LOE ApproachingProduct is in LOE-approaching phase with modest Part D claims (1,361 in 2023), signaling reduced commercial investment and smaller brand team focus.
Mechanism of Action
5-alpha Reductase Inhibitors
Pharmacologic Class:
5-alpha Reductase Inhibitor
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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.