NDAORALTABLET
Approved
Aug 2015
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
14
Data completeness
5/8 — Partial
ADDYI (flibanserin) by Sprout Pharmaceuticals is p-glycoprotein inhibitors [moa]. First approved in 2015.
Drug data last refreshed 4h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ADDYI (flibanserin) is an oral small molecule approved in 2015 for women's sexual health, operating as a P-glycoprotein inhibitor to modulate central nervous system pathways. It represents a first-in-class approach to a historically underserved indication with significant unmet need.
LOE Approaching1.9 years to LOE
Product approaching loss of exclusivity (LOE) in ~2 years with minimal published spending, indicating a mature/declining commercial footprint and likely lean team structure.
Mechanism of Action
P-Glycoprotein Inhibitors
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (14)
Bioequivalence Study of Flibanserin From AphroFemine 100 mg F.C.T (Bio Med for Pharmaceuticals Industries (BIOMED), Egypt) Versus Addyi 100 mg Tablets (Sprout Pharmaceuticals, Inc., USA)
Started Dec 2018
26 enrolled
Healthy
Pharmacokinetics of Flibanserin in Postmenopausal Women With Hypoactive Sexual Desire Disorder (HSDD)
Started Jul 2010
24 enrolled
Sexual Dysfunctions, Psychological
A 28-week Safety Study of Flibanserin in Pre- and Postmenopausal Women With Hypoactive Sexual Desire Disorder
Started Apr 2010
596 enrolled
Sexual Dysfunctions, Psychological
12 Week Safety Trial of Flibanserin in Depressed Women Taking an SSRI or SNRI With Decreased Sexual Desire and Distress
Started Jan 2010
111 enrolled
Sexual Dysfunctions, PsychologicalDepression
Flibanserin for the Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women in North America
Started Jan 2010
748 enrolled
Sexual Dysfunctions, Psychological
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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.