NDAORALFOR SOLUTIONPriority Review
Approved
Oct 1996
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
4/8 — Partial
Priority Review
CYSTADANE (betaine) by Recordati is methylating activity [moa]. First approved in 1996.
Drug data last refreshed 12h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CYSTADANE (betaine) is an oral methylating agent approved in 1996 for the treatment of homocystinuria by enhancing the remethylation of homocysteine to methionine. It works through direct methylating activity to reduce elevated plasma homocysteine levels. The product is administered as an oral powder for solution.
$0.003BPart D
LOE ApproachingStable
Niche rare disease product with modest spending and limited growth potential as patent exclusivity erodes; expect small, specialized commercial team focused on genetic disorder specialists.
Mechanism of Action
Methylating Activity
Pharmacologic Class:
Methylating Agent
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Career Relevance
CYSTADANE offers limited career growth due to niche indication, modest market size ($3M annual Part D spend), and approaching loss of exclusivity. Roles focus on maintaining market share among rare disease specialists and managing the transition to generic competition.
Brand ManagerMedical Science Liaison
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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.