NDASUBCUTANEOUSINJECTABLE
Approved
Dec 1996
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
5/8 — Partial
COPAXONE (glatiramer acetate) by Teva is mechanism(s) by which glatiramer acetate exerts its effects in patients with ms are not fully understood. First approved in 1996.
Drug data last refreshed 10h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
COPAXONE (glatiramer acetate) is a subcutaneous injectable immunomodulator approved in 1996 for multiple sclerosis. It modifies immune processes believed responsible for MS pathogenesis by inducing suppressor T-cells, though its exact mechanism is not fully understood. Patients self-administer daily or three-times-weekly injections to reduce relapse rates.
$0.369BPart D
LOE ApproachingDeclining
Product is approaching loss of exclusivity with ~$369M in 2023 Part D spending; commercial teams are likely consolidating and shifting focus to retention and niche positioning.
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
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Study to Evaluate Oral BIIB061 Added to Interferon-beta1 (IFN-β1) or Glatiramer Acetate in Relapsing Multiple Sclerosis (RMS)
Started Jun 2021
0Relapsing Multiple Sclerosis
Copaxone Subcutaneous Injection Syringe Special Drug Use-Result Investigation (All-Case Investigation) "Prevention of Relapse of Multiple Sclerosis"
Started Nov 2015
1,332 enrolled
Multiple Sclerosis
Study to Assess Medication Satisfaction in Patients With Relapsing Remitting Multiple Sclerosis Treated With Copaxone®
Started Aug 2015
861 enrolled
Multiple Sclerosis
Effectiveness of DMF (Dimethyl Fumarate) and Its Impact on PROs (Patient Reported Outcomes) in Treatment-Naive or Suboptimal IFN (Interferon) or GA (Glatiramer Acetate) Responders With RRMS (ImPROve)
Started May 2015
24 enrolled
Multiple Sclerosis, Relapsing-RemittingRelapsing-Remitting Multiple Sclerosis
Safety and Effectiveness of Cinnomer® (Glatiramer Acetate) in Multiple Sclerosis (MS) Treatment in Iran
Started Apr 2015
368 enrolled
Relapsing Multiple Sclerosis
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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.