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Last Updated: December 12, 2024

GLATIRAMER ACETATE - Generic Drug Details


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What are the generic sources for glatiramer acetate and what is the scope of patent protection?

Glatiramer acetate is the generic ingredient in three branded drugs marketed by Teva Pharms Usa, Mylan, Synthon Pharms Inc, and Sandoz, and is included in seven 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

See drug prices for GLATIRAMER ACETATE

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 UniversityN/A

See all GLATIRAMER ACETATE clinical trials

Medical Subject Heading (MeSH) Categories for GLATIRAMER ACETATE
Anatomical Therapeutic Chemical (ATC) Classes 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
Synthon Pharms Inc GLATIRAMER ACETATE glatiramer acetate INJECTABLE;SUBCUTANEOUS 206873-001 Sep 25, 2024 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Mylan GLATIRAMER ACETATE glatiramer acetate INJECTABLE;SUBCUTANEOUS 206936-001 Oct 3, 2017 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Synthon Pharms Inc GLATIRAMER ACETATE glatiramer acetate INJECTABLE;SUBCUTANEOUS 203857-001 Sep 25, 2024 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Teva Pharms Usa COPAXONE glatiramer acetate INJECTABLE;SUBCUTANEOUS 020622-002 Feb 12, 2002 AP RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sandoz GLATOPA glatiramer acetate INJECTABLE;SUBCUTANEOUS 206921-001 Feb 12, 2018 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 ⤷  Sign Up ⤷  Sign Up
Teva Pharms Usa COPAXONE glatiramer acetate INJECTABLE;SUBCUTANEOUS 020622-003 Jan 28, 2014 ⤷  Sign Up ⤷  Sign Up
Teva Pharms Usa COPAXONE glatiramer acetate FOR SOLUTION;SUBCUTANEOUS 020622-001 Dec 20, 1996 ⤷  Sign Up ⤷  Sign Up
Teva Pharms Usa COPAXONE glatiramer acetate INJECTABLE;SUBCUTANEOUS 020622-002 Feb 12, 2002 ⤷  Sign Up ⤷  Sign Up
Teva Pharms Usa COPAXONE glatiramer acetate INJECTABLE;SUBCUTANEOUS 020622-002 Feb 12, 2002 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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