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 4h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CYSTADANE (betaine) is an oral methylating agent approved in 1996 for treating homocystinuria by reducing plasma homocysteine levels through methylation activity. It is administered as a powder for solution and addresses a rare metabolic disorder characterized by elevated homocysteine. The drug works by providing an alternative pathway for homocysteine metabolism.
$3MPart D
LOE ApproachingWith LOE approaching and minimal Part D spending ($3M), the brand team is likely small and transitioning toward generic competition management strategies.
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
Working on CYSTADANE offers limited growth trajectory given its LOE-approaching status and niche rare disease market ($3M Part D spend, 757 claims). Roles are likely focused on defending market share against generics, optimizing reimbursement, and managing the transition phase rather than driving growth.
Regulatory Affairs ManagerBrand Manager
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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.