NDAORALTABLET
Approved
Nov 1978
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
5/8 — Partial
DEPEN (penicillamine) by Viatris (2) is clinical pharmacology penicillamine is a chelating agent recommended for the removal of excess copper in patients with wilson's disease. First approved in 1978.
Drug data last refreshed 6h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DEPEN (penicillamine) is an oral chelating agent and antirheumatic approved in 1978 for Wilson's disease, cystinuria, and rheumatoid arthritis. It works by binding excess copper and cystine for excretion, and suppresses rheumatoid disease activity through mechanisms including reduction of IgM rheumatoid factor and T-cell depression. Therapeutic response in rheumatoid arthritis typically requires 2–3 months, with symptom suppression evident within 3 months in responders.
LOE Approaching
Product is approaching loss of exclusivity with moderate competitive pressure (30/100), indicating team focus is shifting toward generic transition planning and defensive positioning rather than growth investment.
Mechanism of Action
CLINICAL PHARMACOLOGY Penicillamine is a chelating agent recommended for the removal of excess copper in patients with Wilson's disease. From in vitro studies which indicate that one atom of copper combines with two molecules of penicillamine, it would appear that one gram of penicillamine should…
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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.