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Generated: May 29, 2017

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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 six patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Glatiramer acetate has forty-two 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

Drug Master File Entries: see list4
Suppliers / Packagers: see list2
Clinical Trials: see list441
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
glatiramer acetate
INJECTABLE;SUBCUTANEOUS020622-002Feb 12, 2002APRXYesYes► Subscribe► Subscribe
Sandoz Inc
glatiramer acetate
INJECTABLE;SUBCUTANEOUS090218-001Apr 16, 2015APRXNoNo► Subscribe► Subscribe
Teva Pharms Usa
glatiramer acetate
INJECTABLE;SUBCUTANEOUS020622-003Jan 28, 2014RXYesYes9,402,874► Subscribe ► Subscribe
Teva Pharms Usa
glatiramer acetate
INJECTABLE;SUBCUTANEOUS020622-003Jan 28, 2014RXYesYes8,399,413► Subscribe ► Subscribe
Teva Pharms Usa
glatiramer acetate
INJECTABLE;SUBCUTANEOUS020622-003Jan 28, 2014RXYesYes8,232,250► Subscribe ► Subscribe
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