NDAORALTABLET
Approved
Feb 2013
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
7
Data completeness
6/8 — Strong
OSPHENA (ospemifene) by Duchesnay is selective estrogen receptor modulators [moa]. Approved for estrogen agonist/antagonist [epc]. First approved in 2013.
Drug data last refreshed 16h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
OSPHENA (ospemifene) is an oral selective estrogen receptor modulator (SERM) approved in 2013 for treating moderate to severe dyspareunia due to menopause-related vaginal atrophy in postmenopausal women. It functions as an estrogen agonist/antagonist, selectively modulating estrogen receptor activity in vaginal and reproductive tissues without systemic hormonal effects.
$0.005BPart D
LOE Approaching2.0 years to LOEProduct is approaching loss of exclusivity with modest Part D utilization (8,724 claims, $5M spend in 2023), indicating a small, stable commercial footprint with limited team expansion opportunity.
Mechanism of Action
Selective Estrogen Receptor Modulators
Pharmacologic Class:
Estrogen Agonist/Antagonist
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (7)
Study to Evaluate Ospemifene in Patients With Moderate to Severe Vaginal Dryness Due to Menopause
Started Jan 2016
631 enrolled
Vaginal Dryness
Efficacy and Safety of Ospemifene in the Treatment of Moderate to Severe Vaginal Dryness and Vaginal Pain Associated With Sexual Activity
Started Jul 2008
919 enrolled
AtrophyVaginal Diseases
A Clinical Study to Evaluate the Safety of Ospemifene
Started Oct 2007
426 enrolled
AtrophyVaginal Diseases
A Clinical Study to Evaluate the Efficacy and Safety of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women
Started Aug 2007
126 enrolled
AtrophyVaginal Diseases
Long-Term Safety of 30 mg and 60 mg Oral Daily Dose of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women With Intact Uterus
Started May 2006
180 enrolled
AtrophyVaginal Diseases
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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.