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Last Updated: October 24, 2020

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Glatiramer acetate - Generic Drug Details

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

Glatiramer acetate is the generic ingredient in three branded drugs marketed by Teva Pharms Usa, Mylan, and Sandoz Inc, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

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

Drug Prices for glatiramer acetate

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Recent Clinical Trials for glatiramer acetate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
VU University Medical CenterN/A
Assiut UniversityPhase 1
Mapi Pharma Ltd.Phase 3

See all glatiramer acetate clinical trials

Medical Subject Heading (MeSH) Categories for glatiramer acetate
Paragraph IV (Patent) Challenges for GLATIRAMER ACETATE
Tradename Dosage Ingredient NDA Submissiondate
COPAXONE INJECTABLE;SUBCUTANEOUS glatiramer acetate 020622 2014-02-26
COPAXONE FOR SOLUTION;SUBCUTANEOUS glatiramer acetate 020622 2014-02-26
COPAXONE INJECTABLE;SUBCUTANEOUS glatiramer acetate 020622 2007-12-27
COPAXONE FOR SOLUTION;SUBCUTANEOUS glatiramer acetate 020622 2007-12-27

US Patents and Regulatory Information for glatiramer acetate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan GLATIRAMER ACETATE glatiramer acetate INJECTABLE;SUBCUTANEOUS 091646-001 Oct 3, 2017 AP RX No No   Start Trial   Start Trial   Start Trial
Teva Pharms Usa COPAXONE glatiramer acetate INJECTABLE;SUBCUTANEOUS 020622-003 Jan 28, 2014 AP RX Yes Yes   Start Trial   Start Trial   Start Trial
Mylan GLATIRAMER ACETATE glatiramer acetate INJECTABLE;SUBCUTANEOUS 206936-001 Oct 3, 2017 AP RX No No   Start Trial   Start Trial   Start Trial
Teva Pharms Usa COPAXONE glatiramer acetate INJECTABLE;SUBCUTANEOUS 020622-002 Feb 12, 2002 AP RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for glatiramer acetate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Teva Pharms Usa COPAXONE glatiramer acetate INJECTABLE;SUBCUTANEOUS 020622-003 Jan 28, 2014   Start Trial   Start Trial
Teva Pharms Usa COPAXONE glatiramer acetate INJECTABLE;SUBCUTANEOUS 020622-003 Jan 28, 2014   Start Trial   Start Trial
Teva Pharms Usa COPAXONE glatiramer acetate FOR SOLUTION;SUBCUTANEOUS 020622-001 Dec 20, 1996   Start Trial   Start Trial
Teva Pharms Usa COPAXONE glatiramer acetate INJECTABLE;SUBCUTANEOUS 020622-002 Feb 12, 2002   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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