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COPAXONE Drug Profile

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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 five patents protecting this drug and two Paragraph IV challenges.

This drug has thirty-three patent family members in twenty-three 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 for: COPAXONE

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, 2014RXYes9,402,874<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, 20147,199,098<disabled>
Teva Pharms Usa
COPAXONE
glatiramer acetate
INJECTABLE;SUBCUTANEOUS020622-002Feb 12, 20026,939,539<disabled>
Teva Pharms Usa
COPAXONE
glatiramer acetate
FOR SOLUTION;SUBCUTANEOUS020622-001Dec 20, 19966,362,161<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 Estimated Expiration
Eurasian Patent Organization201400394<disabled in preview>
Australia2010284666<disabled in preview>
Japan2013502415<disabled in preview>
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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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