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Details for Generic Name: glatiramer acetate

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Glatiramer acetate is the generic ingredient in one branded drug marketed by Teva Pharms Usa and is included in one NDA. There are ten patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are three drug master file entries for glatiramer acetate. One supplier is listed for this compound.

Summary for Generic Name: glatiramer acetate

Tradenames:1
Patents:10
Applicants:1
NDAs:1
Drug Master File Entries: see list3
Suppliers: see list1
Therapeutic Class:Immunological Agents

Clinical Trials for: glatiramer acetate

A Study to Evaluate the Safety and Effectiveness of Novantrone Therapy Followed by Copaxone for Multiple Sclerosis.
Status: Completed Condition: Relapsing Remitting Multiple Sclerosis

Safety and Efficacy Study of Copaxone Administered in Combination With Minocycline
Status: Completed Condition: Relapse Remitting Multiple Sclerosis

Evaluate Early Glatiramer Acetate Treatment in Delaying Conversion to Clinically Definite Multiple Sclerosis of Subjects Presenting With Clinically Isolated Syndrome
Status: Completed Condition: Multiple Sclerosis

Evaluation of Two Glatiramer Acetate (GA) Formulations in Relapsing-Remitting Multiple Sclerosis (RRMS) Patients
Status: Completed Condition: Multiple Sclerosis

Assessment Study of Steroid Effect in Relapsing Multiple Sclerosis Subjects Treated With Glatiramer Acetate
Status: Terminated Condition: Relapsing Remitting Multiple Sclerosis

Comparison of Rituximab Induction Therapy Followed by Glatiramer Acetate Therapy to Glatiramer Acetate Monotherapy for MS
Status: Active, not recruiting Condition: Multiple Sclerosis

Clinical Trial Comparing Treatment of Relapsing-Remitting Multiple Sclerosis (RR-MS) With Two Doses of Glatiramer Acetate (GA).
Status: Completed Condition: Relapsing Remitting Multiple Sclerosis

Treatment of Multiple Sclerosis With Copaxone and Albuterol
Status: Completed Condition: Autoimmune Diseases; Multiple Sclerosis

Optical Coherence Tomography: Glatiramer in Clinically Isolated Syndrome or Early Relapsing Remitting Multiple Sclerosis (MS)
Status: Recruiting Condition: Multiple Sclerosis

Anti-Inflammatory Type II Monocyte Induction by Glatiramer Acetate (Copaxone) Treatment of Multiple Sclerosis
Status: Completed Condition: Multiple Sclerosis

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva Pharms Usa
COPAXONE
glatiramer acetate
INJECTABLE;SUBCUTANEOUS020622Jan 28, 2014RXYes6,054,430<disabled>Y<disabled>
Teva Pharms Usa
COPAXONE
glatiramer acetate
INJECTABLE;SUBCUTANEOUS020622Jan 28, 2014RXYes8,367,605<disabled>Y<disabled>
Teva Pharms Usa
COPAXONE
glatiramer acetate
INJECTABLE;SUBCUTANEOUS020622Jan 28, 2014RXYes8,399,413<disabled><disabled>
Teva Pharms Usa
COPAXONE
glatiramer acetate
INJECTABLE;SUBCUTANEOUS020622Jan 28, 2014RXYes6,362,161<disabled>Y<disabled>
Teva Pharms Usa
COPAXONE
glatiramer acetate
INJECTABLE;SUBCUTANEOUS020622Feb 12, 2002RXYes6,054,430<disabled><disabled>
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