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Serving 500+ biopharmaceutical companies globally:

Fuji
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Teva
Cipla
QuintilesIMS
Johnson and Johnson
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Generated: July 28, 2017

DrugPatentWatch Database Preview

Glatiramer acetate - Generic Drug Details

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What are the generic drug sources for glatiramer acetate and what is the scope of glatiramer acetate freedom to operate?

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.

Glatiramer acetate has forty-four patent family members in twenty-seven 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 / Packagers: see list2
Clinical Trials: see list916
Therapeutic Class:Immunological Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:glatiramer acetate 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
INJECTABLE;SUBCUTANEOUS020622-003Jan 28, 2014RXYesYes► Subscribe► Subscribe ► Subscribe
Teva Pharms Usa
COPAXONE
glatiramer acetate
INJECTABLE;SUBCUTANEOUS020622-003Jan 28, 2014RXYesYes► Subscribe► Subscribe ► Subscribe
Sandoz Inc
GLATOPA
glatiramer acetate
INJECTABLE;SUBCUTANEOUS090218-001Apr 16, 2015APRXNoNo► 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
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Expired Orange Book Patents for Generic Ingredient: glatiramer acetate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
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
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
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International Patent Family for Ingredient: glatiramer acetate

Country Document Number Estimated Expiration
Slovenia2949335► Subscribe
Denmark2405749► Subscribe
Canada2760802► Subscribe
Ukraine103699► Subscribe
Czech Republic30474► 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:

Covington
Baxter
Fuji
Deloitte
Farmers Insurance
Federal Trade Commission
Novartis
Fish and Richardson
UBS
US Department of Justice

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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