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Profile for Tradename: COPAXONE

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Copaxone is a drug marketed by Teva Pharms Usa and is included in one NDA. It is available from one supplier. There are four patents protecting this drug and two Paragraph IV challenges.

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

The generic ingredient in COPAXONE is glatiramer acetate. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the glatiramer acetate profile page.

Summary for Tradename: COPAXONE

Patents:4
Applicants:1
NDAs:1
Suppliers / Packagers: see list4
2013 Sales:$3,697,182,000

Clinical Trials for: COPAXONE

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

Phase IV Study, Betaseron Versus Copaxone for Relapsing Remitting or CIS Forms of MS Using Triple Dose Gad 3 T MRI
Status: Active, not recruiting Condition: Multiple Sclerosis

A Study to Evaluate the Impact on Skin (Injection Site) Reactions of Taking an Antihistamine (Zyrtec®) or Placebo Prior to Daily Injections of Copaxone®.
Status: Completed Condition: Multiple Sclerosis

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

Efficacy and Safety of GTR in Comparison to Copaxone®
Status: Completed Condition: Multiple Sclerosis

Effects of Copaxone in the Retinal Function in Diabetic Patients After Panphotocoagulation
Status: Active, not recruiting Condition: Diabetic Retinopathy

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

Investigating the Neuroprotective Effect of Cop-1 (Copaxone) in Acute Primary Angle Closure
Status: Recruiting Condition: Glaucoma, Angle-closure, Primary, Acute

Pharmacological Treatment of Rett Syndrome With Glatiramer Acetate (Copaxone)
Status: Active, not recruiting Condition: Rett Syndrome

A Study to Evaluate the Impact of Using Warm Compress Prior to Daily Injections of Copaxone®
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
FOR SOLUTION;SUBCUTANEOUS020622-001Dec 20, 1996DISCNNo<disabled><disabled>
Teva Pharms Usa
COPAXONE
glatiramer acetate
INJECTABLE;SUBCUTANEOUS020622-003Jan 28, 2014RXYes<disabled><disabled>
Teva Pharms Usa
COPAXONE
glatiramer acetate
INJECTABLE;SUBCUTANEOUS020622-003Jan 28, 2014RXYes8,399,413<disabled> <disabled>
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Expired Patents for Tradename: COPAXONE

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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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Paragraph IV activity for: COPAXONE

Drugname Dosage Strength RLD Submissiondate
glatiramer acetateInjection40 mg/mL, 1 mL pre-filled syringeCopaxone1/29/2014
glatiramer acetateInjection40 mg/mL, 1 mL pre-filled syringeCopaxone2/26/2014

International Patent Family for Tradename: COPAXONE

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.

Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided information. There is no warranty that the information contained herein is error free. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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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