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Serving leading biopharmaceutical companies globally:

Harvard Business School
Moodys
Deloitte
Daiichi Sankyo
Merck
Accenture
AstraZeneca
Covington
QuintilesIMS
McKesson

Generated: October 24, 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 three branded drugs marketed by Sandoz Inc, Teva Pharms Usa, and Mylan Pharms Inc, and is included in four 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 sixty-three patent family members in thirty-one countries.

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

Summary for Generic Name: glatiramer acetate

US Patents:5
Tradenames:3
Applicants:3
NDAs:4
Drug Master File Entries: see list4
Suppliers / Packagers: see list3
Clinical Trials: see list943
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, 2014APRXYesYes► Subscribe► Subscribe ► Subscribe
Teva Pharms Usa
COPAXONE
glatiramer acetate
INJECTABLE;SUBCUTANEOUS020622-003Jan 28, 2014APRXYesYes► Subscribe► Subscribe► Subscribe
Sandoz Inc
GLATOPA
glatiramer acetate
INJECTABLE;SUBCUTANEOUS090218-001Apr 16, 2015APRXNoNo► Subscribe► Subscribe► Subscribe
Mylan Pharms Inc
GLATIRAMER ACETATE
glatiramer acetate
INJECTABLE;SUBCUTANEOUS091646-001Oct 3, 2017APRXNoNo► Subscribe► Subscribe► Subscribe
Teva Pharms Usa
COPAXONE
glatiramer acetate
INJECTABLE;SUBCUTANEOUS020622-003Jan 28, 2014APRXYesYes► Subscribe► Subscribe ► Subscribe
Mylan Pharms Inc
GLATIRAMER ACETATE
glatiramer acetate
INJECTABLE;SUBCUTANEOUS206936-001Oct 3, 2017APRXNoNo► Subscribe► Subscribe► Subscribe
Teva Pharms Usa
COPAXONE
glatiramer acetate
INJECTABLE;SUBCUTANEOUS020622-003Jan 28, 2014APRXYesYes► 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, 2014APRXYesYes► Subscribe► Subscribe ► Subscribe
Teva Pharms Usa
COPAXONE
glatiramer acetate
FOR SOLUTION;SUBCUTANEOUS020622-001Dec 20, 1996DISCNNoNo► 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
INJECTABLE;SUBCUTANEOUS020622-003Jan 28, 2014► 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
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;SUBCUTANEOUS020622-002Feb 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
INJECTABLE;SUBCUTANEOUS020622-003Jan 28, 2014► Subscribe► Subscribe
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International Patent Family for Ingredient: glatiramer acetate

Country Document Number Estimated Expiration
San MarinoT201700057► Subscribe
Singapore10201405806S► Subscribe
China102625657► Subscribe
Japan2013502415► Subscribe
HungaryE031282► Subscribe
China105770855► Subscribe
South Korea20120090044► Subscribe
Cyprus1118529► Subscribe
SloveniaEP2949335► Subscribe
Serbia52885► 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 leading biopharmaceutical companies globally:

Citi
Cipla
UBS
QuintilesIMS
Queensland Health
Healthtrust
McKesson
Cantor Fitzgerald
Moodys
Baxter

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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