Wednesday, July 8, 2026

Drug profile · INN

glatiramer acetate

glatiramer acetate (COPAXONE) is a unknown. Associated with Lacuna Pharma Pty Ltd. Route of administration: subcutaneous. Current US regulatory status: approved.

FDA: approved TGA: approved
US status approved
Patents linked 19
Pipeline programs 16
News articles 0
Drug details — glatiramer acetate
US status
approved
Class
Route
SUBCUTANEOUS
Patents
19
Programs
16
Data quality
0.89

Quick answer

glatiramer acetate (COPAXONE) is a unknown. Associated with Lacuna Pharma Pty Ltd. Route of administration: subcutaneous. Current US regulatory status: approved.

Key facts

INN glatiramer acetate
Brand COPAXONE
Mechanism Unknown
Route SUBCUTANEOUS
Formulation INJECTABLE

Mechanism of action

Unknown

Approval history

Authority Status Date
FDA approved
TGA approved

Pipeline programs

  1. COMB157G3301 Phase 3 · Novartis India · relapsing multiple sclerosis (RMS)
  2. Glatiramer Acetate Phase 3 · Teva Pharma · Optic Neuritis
  3. Glatiramer Acetate (DB) Phase 3 · Teva Pharma · Multiple Sclerosis
  4. Glatiramer Acetate (GA) 40 mg Phase 3 · Teva Pharma · Relapsing Remitting Multiple Sclerosis
  5. Glatiramer Acetate 20 mg/0.5 mL Phase 3 · Teva Pharma · Multiple Sclerosis
  6. Glatiramer acetate (GA) Phase 3 · Teva Pharma · Relapsing Remitting Multiple Sclerosis
  7. 40 mg glatiramer acetate Phase 2 · Teva Pharma · Amyotrophic Lateral Sclerosis
  8. Glatiramer Acetate, N-Acetylcysteine Phase 2 · Teva Pharma · Relapse Remitting Multiple Sclerosis
  1. US 9763993

    Process for manufacturing glatiramer acetate product

    Expires Mon Sep 14 2037 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 9702007

    Genetic markers predictive of response to glatiramer acetate

    Expires Mon Jul 06 2037 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  3. US 9687522

    Methods of treating a subject afflicted with an autoimmune disease using predictive biomarkers of clinical response to glatiramer acetate therapy in multiple sclerosis

    Expires Mon Jun 22 2037 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  4. US 9625473

    Cytokine biomarkers as predictive biomarkers of clinical response for glatiramer acetate

    Expires Mon Apr 13 2037 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  5. US 9617596

    Biomarkers predictive for clinical response for glatiramer acetate

    Expires Mon Apr 06 2037 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  6. US 9499868

    Determination of single nucleotide polymorphisms useful to predict response for glatiramer acetate

    Expires Mon Nov 17 2036 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  7. US 9155775

    Process for manufacturing glatiramer acetate product

    Expires Mon Oct 08 2035 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  8. US 9063153

    Cytokine biomarkers as predictive biomarkers of clinical response for glatiramer acetate

    Expires Mon Jun 18 2035 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  9. US 9018170

    Reduced volume formulation of glatiramer acetate and methods of administration

    Expires Mon Apr 23 2035 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  10. US 8920373

    Reduced volume formulation of glatiramer acetate and methods of administration

    Expires Mon Dec 25 2034 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  11. US 8815511

    Determination of single nucleotide polymorphisms useful to predict response for glatiramer acetate

    Expires Mon Aug 21 2034 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  12. US 8759302

    Methods of treating a subject afflicted with an autoimmune disease using predictive biomarkers of clinical response to glatiramer acetate therapy in multiple sclerosis

    Expires Mon Jun 19 2034 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  13. US 8709433

    Cytokine biomarkers as predictive biomarkers of clinical response for Glatiramer acetate

    Expires Mon Apr 24 2034 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  14. US 8389228

    Process for the measurement of the potency of glatiramer acetate

    Expires Mon Feb 28 2033 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  15. US 7968511

    Combination therapy with glatiramer acetate and mitoxantrone for the treatment of multiple sclerosis

    Expires Mon Jun 23 2031 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  16. US 7923215

    Process for the measurement of the potency of glatiramer acetate

    Expires Mon Apr 07 2031 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  17. US 7855176

    Reduced volume formulation of glatiramer acetate and methods of administration

    Expires Mon Dec 16 2030 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  18. US 7429374

    Process for the measurement of the potency of glatiramer acetate

    Expires Mon Sep 25 2028 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  19. US 7033582

    Use of glatiramer acetate (copolymer 1) in the treatment of central nervous system disorders

    Expires Mon Apr 20 2026 00:00:00 GMT+0000 (Coordinated Universal Time)

    expired

Frequently asked questions

What is glatiramer acetate?

glatiramer acetate (COPAXONE) is a unknown. Associated with Lacuna Pharma Pty Ltd. Route of administration: subcutaneous. Current US regulatory status: approved.

What is the brand name for glatiramer acetate?

COPAXONE is a marketed brand name for glatiramer acetate. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of glatiramer acetate?

glatiramer acetate has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.