COPAXONE Drug Patent Profile

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 3^rd, 2017.

Summary for COPAXONE

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	28
Clinical Trials:	52
Drug Prices:	Drug price information for COPAXONE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for COPAXONE
What excipients (inactive ingredients) are in COPAXONE?	COPAXONE excipients list
DailyMed Link:	COPAXONE at DailyMed

See drug prices for COPAXONE

See drug sales revenues for COPAXONE

Recent Clinical Trials for COPAXONE

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

Sponsor	Phase
University of Kansas Medical Center	Phase 1
Genzyme, a Sanofi Company	Phase 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
Teva Pharms Usa	COPAXONE	glatiramer acetate	INJECTABLE;SUBCUTANEOUS	020622-002	Feb 12, 2002	AP	RX	Yes	Yes
Teva Pharms Usa	COPAXONE	glatiramer acetate	INJECTABLE;SUBCUTANEOUS	020622-003	Jan 28, 2014	AP	RX	Yes	Yes

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	020622-002	Feb 12, 2002
Teva Pharms Usa	COPAXONE	glatiramer acetate	INJECTABLE;SUBCUTANEOUS	020622-003	Jan 28, 2014
Teva Pharms Usa	COPAXONE	glatiramer acetate	FOR SOLUTION;SUBCUTANEOUS	020622-001	Dec 20, 1996
Teva Pharms Usa	COPAXONE	glatiramer acetate	INJECTABLE;SUBCUTANEOUS	020622-002	Feb 12, 2002
Teva Pharms Usa	COPAXONE	glatiramer acetate	INJECTABLE;SUBCUTANEOUS	020622-003	Jan 28, 2014

International Patents for COPAXONE

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

Country	Patent Number	Title	Estimated Expiration
Israel	133890
Slovenia	3199172
Ukraine	62908	Translated By PlajФРАКЦИИ КОПОЛИМЕРА-1, СПОСОБЫ ИХ ПОЛУЧЕНИЯ, КОМПОЗИЦИИ И СПОСОБ ДЛЯ ЛЕЧЕНИЯ РАССЕЯННОГО СКЛЕРОЗА;ФРАКЦІЇ КОПОЛІМЕРУ-1, CПОСОБИ ЇХ ОДЕРЖАННЯ, КОМПОЗИЦІЇ ТА СПОСІБ ДЛЯ ЛІКУВАННЯ РОЗСІЯНОГО СКЛЕРОЗУ (FRACTIONS OF COPOLYMER-1, METHODS FOR PREPARATION THEREOF, COMPOSITIONS AND A METHOD FOR TREATMENT OF DISSEMINATED SCLEROSIS)
Hungary	E039335
Argentina	099078	UN MEDICAMENTO QUE COMPRENDE ACETATO DE GLATIRAMER

Supplementary Protection Certificates for COPAXONE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0762888	90987	Luxembourg
0762888	C300251	Netherlands		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
0762888	C300096	Netherlands		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