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Last Updated: February 28, 2024

COPAXONE Drug Patent Profile


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When do Copaxone patents expire, and when can generic versions of Copaxone launch?

Copaxone is a drug marketed by Teva Pharms Usa and is included in one NDA.

The generic ingredient in COPAXONE is glatiramer acetate. There are five drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the glatiramer acetate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Copaxone

A generic version of COPAXONE was approved as glatiramer acetate by MYLAN on October 3rd, 2017.

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Drug patent expirations by year for COPAXONE
Drug Prices for COPAXONE

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Drug Sales Revenue Trends for COPAXONE

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Recent Clinical Trials for COPAXONE

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SponsorPhase
University of Kansas Medical CenterPhase 1
Genzyme, a Sanofi CompanyPhase 3
Teva Pharmaceutical Industries, Ltd.Phase 4

See all COPAXONE clinical trials

Paragraph IV (Patent) Challenges for COPAXONE
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 COPAXONE

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 FOR SOLUTION;SUBCUTANEOUS 020622-001 Dec 20, 1996 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
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 INJECTABLE;SUBCUTANEOUS 020622-003 Jan 28, 2014 AP RX Yes Yes ⤷  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 COPAXONE

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 ⤷  Try a Trial ⤷  Try a Trial
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 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 FOR SOLUTION;SUBCUTANEOUS 020622-001 Dec 20, 1996 ⤷  Try a Trial ⤷  Try a Trial
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 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

International Patents for COPAXONE

See the table below for patents covering COPAXONE around the world.

Country Patent Number Title Estimated Expiration
Eurasian Patent Organization 032287 ТЕРАПИЯ ГЛАТИРАМЕРОМ АЦЕТАТОМ С НИЗКОЙ КРАТНОСТЬЮ (LOW FREQUENCY GLATIRAMER ACETATE THERAPY) ⤷  Try a Trial
China 1174753 ⤷  Try a Trial
Slovakia 283699 ⤷  Try a Trial
Slovakia 149396 COPOLYMER-1 IMPROVEMENTS IN COMPOSITIONS OF COPOLYMERS ⤷  Try a Trial
Japan 6169644 ⤷  Try a Trial
Portugal 3199172 ⤷  Try a Trial
Poland 2949335 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for COPAXONE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0762888 C300096 Netherlands ⤷  Try a Trial PRODUCT NAME: GLATIRAMEER, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET ACETAAT; NAT. REGISTRATION NO/DATE: RVG 26748 20010927: FIRST REGISTRATION: GB PL 10921/0019 20000809
0762888 90987 Luxembourg ⤷  Try a Trial
0762888 C300251 Netherlands ⤷  Try a Trial PRODUCT NAME: GLATIRAMEER, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET ACETAAT; NATL. REGISTRATION NO/DATE: RVG 26748 20010927; FIRST REGISTRATION: GB PL 10921/0019 20000809
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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