NDAORALFOR SOLUTIONPriority Review
Approved
Oct 1996
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
5/8 — Partial
Priority Review
CYSTADANE (betaine) by Recordati is methylating activity [moa]. Approved for unipolar depression. First approved in 1996.
Drug data last refreshed 21h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CYSTADANE (betaine) is an oral methylating agent approved in 1996 for the treatment of unipolar depression. It works through methylating activity to modulate neurotransmitter pathways. The drug is supplied as a powder for oral solution.
$0.003BPart D
LOE ApproachingProduct approaching loss of exclusivity with minimal Part D utilization (757 claims in 2023) suggests small, stable market with limited growth trajectory for commercial teams.
Mechanism of Action
Methylating Activity
Pharmacologic Class:
Methylating Agent
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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.