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Glatiramer acetate - Generic Drug Details

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

This ingredient has thirty-four patent family members in twenty-three countries.

There are four drug master file entries for glatiramer acetate. Two suppliers are listed for this compound.

Summary for Generic Name: glatiramer acetate

Tradenames:2
Patents:5
Applicants:2
NDAs:2
Drug Master File Entries: see list4
Suppliers / Packaging: see list2
Therapeutic Class:Immunological Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
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, 2014RXYes8,969,302► subscribe ► subscribe
Teva Pharms Usa
COPAXONE
glatiramer acetate
INJECTABLE;SUBCUTANEOUS020622-003Jan 28, 2014RXYes8,232,250► subscribe ► subscribe
Teva Pharms Usa
COPAXONE
glatiramer acetate
FOR SOLUTION;SUBCUTANEOUS020622-001Dec 20, 1996DISCNNo► subscribe► subscribe
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Expired Orange Book Patents for Generic Ingredient: glatiramer acetate

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Teva Pharms Usa
COPAXONE
glatiramer acetate
INJECTABLE;SUBCUTANEOUS020622-002Feb 12, 20026,342,476► subscribe
Teva Pharms Usa
COPAXONE
glatiramer acetate
FOR SOLUTION;SUBCUTANEOUS020622-001Dec 20, 19967,199,098► subscribe
Teva Pharms Usa
COPAXONE
glatiramer acetate
INJECTABLE;SUBCUTANEOUS020622-003Jan 28, 20146,362,161► subscribe
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International Patent Family for Ingredient: glatiramer acetate

Country Document Number Estimated Expiration
Singapore10201405806S► subscribe
World Intellectual Property Organization (WIPO)2011022063► subscribe
China105770855► 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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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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