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Last Updated: November 17, 2019

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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 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. 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 eighty-four patent family members in thirty-two countries.

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

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SponsorPhase
Mapi Pharma Ltd.Phase 3
University of Kansas Medical CenterPhase 1
Mapi Pharma Ltd.Phase 2

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Recent Litigation for glatiramer acetate

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District Court Litigation
Case NameDate
Teva Pharmaceuticals USA, Inc. v. Sandoz Inc.2017-05-24
Teva Pharmaceuticals USA, Inc. v. Mylan Pharmaceuticals Inc.2017-03-10
Teva Pharmaceuticals USA, Inc. v. Mylan Pharmaceuticals Inc.2017-01-17

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PTAB Litigation
PetitionerDate
Mylan Pharmaceuticals Inc.2016-11-02
Amneal Pharmaceuticals LLC2016-07-12
Mylan Pharmaceuticals Inc.2016-02-16

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Medical Subject Heading (MeSH) Categories for glatiramer acetate
Synonyms for glatiramer acetate
147245-92-9
5M691HL4BO
943513-95-9
AB0110033
AC-28732
AC1MIXQC
acetic acid; (2S)-2-amino-3-(4-hydroxyphenyl)propanoic acid; (2S)-2-aminopentanedioic acid; (2S)-2-aminopropanoic acid; (2S)-2,6-diaminohexanoic acid
AM84438
AN-6995
C9H11NO3.C6H14N2O2.
COP-1
Copaxone
Copolymer 1
Copolymer-1
DTXSID30163637
FHEAIOHRHQGZPC-KIWGSFCNSA-N
FT-0686728
Glatiramer acetate [USAN:BAN]
Glatirameracetat
Glatopa
L-alanine compound with L-glutamic acid and L-lysine and L-tyrosine and acetic acid (1:1:1:1:1)
L-Glutamic acid peptide with L-alanine, L-lysine and L-tyrosine, acetate (salt)
LS-186971
LS-71889
Protiramer
TV 5010
UNII-5M691HL4BO
Y0429
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 FOR SOLUTION;SUBCUTANEOUS glatiramer acetate 020622 2007-12-27
COPAXONE INJECTABLE;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 206936-001 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
Teva Pharms Usa COPAXONE glatiramer acetate FOR SOLUTION;SUBCUTANEOUS 020622-001 Dec 20, 1996 DISCN No No   Start Trial   Start Trial   Start Trial
Sandoz Inc GLATOPA glatiramer acetate INJECTABLE;SUBCUTANEOUS 090218-001 Apr 16, 2015 AP RX No No   Start Trial   Start Trial   Start Trial
Sandoz Inc GLATOPA glatiramer acetate INJECTABLE;SUBCUTANEOUS 206921-001 Feb 12, 2018 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
>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 FOR SOLUTION;SUBCUTANEOUS 020622-001 Dec 20, 1996   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 FOR SOLUTION;SUBCUTANEOUS 020622-001 Dec 20, 1996   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 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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