NDATOPICALOINTMENT
Approved
Oct 2006
Lifecycle
LOE Approaching
Competitive Pressure
25/100
Clinical Trials
2
Data completeness
5/8 — Partial
VEREGEN (sinecatechins) by ANI Pharmaceuticals is unknown. First approved in 2006.
Drug data last refreshed Yesterday
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Veregen is a topical ointment containing sinecatechins approved for basal cell carcinoma (BCC). Its mechanism of action is not fully characterized, though in vitro studies suggest anti-oxidative activity. The clinical significance of this mechanism remains unknown.
$0.235MPart D
LOE Approaching5mo to LOEWith only ~6 months until patent expiration and minimal Medicare utilization ($235K annual spending), the brand team faces imminent loss of exclusivity and will likely be restructured.
Mechanism of Action
unknown. In vitro, sinecatechins had anti-oxidative activity; the clinical significance of this finding is unknown.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (2)
Systemic Exposure of Catechins From Veregen 15% Ointment in Patients With External Anogenital Warts and From Oral Intake of Green Tea Beverage in Healthy Volunteers
Started Dec 2011
30 enrolled
Anogenital Warts
Pharmacokinetic Study of Topically Applied Veregen 15% Compared With Oral Intake of Green Tea Beverage
Started Jan 2010
43 enrolled
Genital WartsPerianal Warts
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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.