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Serving 500+ biopharmaceutical companies globally:

Moodys
Covington
Fuji
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Federal Trade Commission
AstraZeneca
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Generated: September 22, 2017

DrugPatentWatch Database Preview

COPAXONE Drug Profile

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What is the patent landscape for Copaxone, and what generic Copaxone alternatives are available?

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

This drug has fifty-five patent family members in thirty-one countries.

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

Summary for Tradename: COPAXONE

Patents:5
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Clinical Trials: see list50
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:COPAXONE at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva Pharms Usa
COPAXONE
glatiramer acetate
FOR SOLUTION;SUBCUTANEOUS020622-001Dec 20, 1996DISCNNoNo► Subscribe► Subscribe► Subscribe
Teva Pharms Usa
COPAXONE
glatiramer acetate
INJECTABLE;SUBCUTANEOUS020622-003Jan 28, 2014RXYesYes► Subscribe► Subscribe ► Subscribe
Teva Pharms Usa
COPAXONE
glatiramer acetate
INJECTABLE;SUBCUTANEOUS020622-003Jan 28, 2014RXYesYes► Subscribe► Subscribe ► Subscribe
Teva Pharms Usa
COPAXONE
glatiramer acetate
INJECTABLE;SUBCUTANEOUS020622-003Jan 28, 2014RXYesYes► Subscribe► Subscribe► Subscribe
Teva Pharms Usa
COPAXONE
glatiramer acetate
INJECTABLE;SUBCUTANEOUS020622-002Feb 12, 2002APRXYesYes► Subscribe► Subscribe► Subscribe
Teva Pharms Usa
COPAXONE
glatiramer acetate
INJECTABLE;SUBCUTANEOUS020622-003Jan 28, 2014RXYesYes► Subscribe► Subscribe ► Subscribe
Teva Pharms Usa
COPAXONE
glatiramer acetate
INJECTABLE;SUBCUTANEOUS020622-003Jan 28, 2014RXYesYes► Subscribe► Subscribe ► Subscribe
Teva Pharms Usa
COPAXONE
glatiramer acetate
INJECTABLE;SUBCUTANEOUS020622-003Jan 28, 2014RXYesYes► Subscribe► Subscribe ► Subscribe
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Expired Patents for Tradename: COPAXONE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Teva Pharms Usa
COPAXONE
glatiramer acetate
INJECTABLE;SUBCUTANEOUS020622-002Feb 12, 2002► Subscribe► Subscribe
Teva Pharms Usa
COPAXONE
glatiramer acetate
INJECTABLE;SUBCUTANEOUS020622-003Jan 28, 2014► Subscribe► Subscribe
Teva Pharms Usa
COPAXONE
glatiramer acetate
INJECTABLE;SUBCUTANEOUS020622-002Feb 12, 2002► Subscribe► Subscribe
Teva Pharms Usa
COPAXONE
glatiramer acetate
INJECTABLE;SUBCUTANEOUS020622-003Jan 28, 2014► Subscribe► Subscribe
Teva Pharms Usa
COPAXONE
glatiramer acetate
FOR SOLUTION;SUBCUTANEOUS020622-001Dec 20, 1996► Subscribe► Subscribe
Teva Pharms Usa
COPAXONE
glatiramer acetate
FOR SOLUTION;SUBCUTANEOUS020622-001Dec 20, 1996► Subscribe► Subscribe
Teva Pharms Usa
COPAXONE
glatiramer acetate
INJECTABLE;SUBCUTANEOUS020622-003Jan 28, 2014► Subscribe► Subscribe
Teva Pharms Usa
COPAXONE
glatiramer acetate
FOR SOLUTION;SUBCUTANEOUS020622-001Dec 20, 1996► Subscribe► Subscribe
Teva Pharms Usa
COPAXONE
glatiramer acetate
INJECTABLE;SUBCUTANEOUS020622-002Feb 12, 2002► Subscribe► Subscribe
Teva Pharms Usa
COPAXONE
glatiramer acetate
FOR SOLUTION;SUBCUTANEOUS020622-001Dec 20, 1996► Subscribe► Subscribe
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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 Estimated Expiration
Portugal2405749► Subscribe
Spain2612001► Subscribe
Lithuania2949335► Subscribe
Hong Kong1218250► Subscribe
Poland2949335► Subscribe
European Patent Office2630962► Subscribe
San MarinoT201700057► Subscribe
Argentina077896► Subscribe
Singapore10201405806S► Subscribe
Denmark201600003► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

McKinsey
Federal Trade Commission
QuintilesIMS
Covington
Teva
UBS
Queensland Health
AstraZeneca
Farmers Insurance
Chinese Patent Office

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 data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. 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.

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