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Last Updated: March 19, 2024

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, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for glatiramer acetate. Four 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
Assistance Publique - Hôpitaux de ParisPhase 2/Phase 3
Institut National de la Santé Et de la Recherche Médicale, FrancePhase 2/Phase 3
National Cheng-Kung University HospitalN/A

See all glatiramer acetate clinical trials

Medical Subject Heading (MeSH) Categories for glatiramer acetate
Paragraph IV (Patent) Challenges for GLATIRAMER ACETATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
COPAXONE Injection glatiramer acetate 40 mg/mL, 1 mL pre- filled syringe 020622 2 2014-02-26
COPAXONE Injection glatiramer acetate 20 mg/mL, 1mL pre- filled syringe 020622 1 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
Teva Pharms Usa COPAXONE glatiramer acetate INJECTABLE;SUBCUTANEOUS 020622-002 Feb 12, 2002 AP RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Teva Pharms Usa COPAXONE glatiramer acetate FOR SOLUTION;SUBCUTANEOUS 020622-001 Dec 20, 1996 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan GLATIRAMER ACETATE glatiramer acetate INJECTABLE;SUBCUTANEOUS 206936-001 Oct 3, 2017 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 020622-002 Feb 12, 2002 ⤷  Try a Trial ⤷  Try a Trial
Teva Pharms Usa COPAXONE glatiramer acetate FOR SOLUTION;SUBCUTANEOUS 020622-001 Dec 20, 1996 ⤷  Try a Trial ⤷  Try a Trial
Teva Pharms Usa COPAXONE glatiramer acetate INJECTABLE;SUBCUTANEOUS 020622-003 Jan 28, 2014 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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