NDASUBCUTANEOUSINJECTABLE
Approved
Dec 1996
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
6/8 — Strong
COPAXONE (glatiramer acetate) by Teva is mechanism(s) by which glatiramer acetate exerts its effects in patients with ms are not fully understood. Approved for relapsing-remitting multiple sclerosis, multiple sclerosis. First approved in 1996.
Drug data last refreshed 22h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
COPAXONE (glatiramer acetate) is a subcutaneous immunomodulatory agent approved in 1996 for relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. The drug modulates immune responses by inducing glatiramer acetate-specific suppressor T-cells in the periphery, though its exact mechanism of action in MS remains incompletely understood. It represents one of the foundational disease-modifying therapies in MS and is now in the loss-of-exclusivity phase, facing significant competitive pressure from newer oral and monoclonal antibody alternatives.
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Mechanism of Action
mechanism(s) by which glatiramer acetate exerts its effects in patients with MS are not fully understood. However, glatiramer acetate is thought to act by modifying immune processes that are believed to be responsible for the pathogenesis of MS. This hypothesis is supported by findings of studies…
Indications (2)
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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.