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Details for Generic Name: glatiramer acetate

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Glatiramer acetate is the generic ingredient in two branded drugs marketed by Teva Pharms Usa and Sandoz Inc, and is included in two NDAs. There are four patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has thirty-one patent family members in twenty-two countries.

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

Summary for Generic Name: glatiramer acetate

Tradenames:2
Patents:4
Applicants:2
NDAs:2
Drug Master File Entries: see list4
Suppliers / Packaging: see list4
Therapeutic Class:Immunological Agents

Clinical Trials for: glatiramer acetate

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

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

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

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

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

Safety and Tolerability of Glatiramer Acetate
Status: Completed Condition: Relapsing-Remitting Multiple Sclerosis

Comparison of Rituximab Induction Therapy Followed by Glatiramer Acetate Therapy to Glatiramer Acetate Monotherapy for MS
Status: Completed 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

An Efficacy, Safety and Tolerability Study of Glatiramer Acetate (GA) 20 mg/0.5 ml New Formulation Administered Daily by Subcutaneous (SC) Injection in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS)
Status: Terminated Condition: Relapsing-Remitting 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
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;SUBCUTANEOUS020622-003Jan 28, 2014RXYes<disabled><disabled>
Teva Pharms Usa
COPAXONE
glatiramer acetate
INJECTABLE;SUBCUTANEOUS020622-003Jan 28, 2014RXYes8,232,250<disabled> <disabled>
Teva Pharms Usa
COPAXONE
glatiramer acetate
INJECTABLE;SUBCUTANEOUS020622-003Jan 28, 2014RXYes8,969,302<disabled> <disabled>
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Expired Orange Book Patents for Generic Ingredient: glatiramer acetate

These historical archives are available as an add-on to one-year subscriptions

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Teva Pharms Usa
COPAXONE
glatiramer acetate
INJECTABLE;SUBCUTANEOUS020622-003Jan 28, 20146,342,476<disabled>
Teva Pharms Usa
COPAXONE
glatiramer acetate
FOR SOLUTION;SUBCUTANEOUS020622-001Dec 20, 19965,981,589<disabled>
Teva Pharms Usa
COPAXONE
glatiramer acetate
INJECTABLE;SUBCUTANEOUS020622-002Feb 12, 20025,981,589<disabled>
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International Patent Family for Ingredient: glatiramer acetate

Country Document Number Publication Date
New Zealand598661Feb 22, 2013
European Patent Office2949335Dec 02, 2015
Japan2013502415Jan 24, 2013
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

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Copyright 2002-2016 thinkBiotech LLC
ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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