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Generated: December 10, 2018

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COPAXONE Drug 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. There are five patents protecting this drug and two Paragraph IV challenges.

This drug has sixty-three patent family members in thirty-one countries.

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

Drug patent expirations by year for COPAXONE
Medical Subject Heading (MeSH) Categories for COPAXONE
Synonyms for COPAXONE
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
Copolymer 1
Copolymer-1
DR003397
DTXSID30163637
FHEAIOHRHQGZPC-KIWGSFCNSA-N
FT-0686728
Glatiramer acetate
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
OR222690
Protiramer
UNII-5M691HL4BO
Y0429

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 No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Teva Pharms Usa COPAXONE glatiramer acetate INJECTABLE;SUBCUTANEOUS 020622-003 Jan 28, 2014 AP RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Teva Pharms Usa COPAXONE glatiramer acetate INJECTABLE;SUBCUTANEOUS 020622-003 Jan 28, 2014 AP RX Yes Yes ➤ 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
Teva Pharms Usa COPAXONE glatiramer acetate INJECTABLE;SUBCUTANEOUS 020622-003 Jan 28, 2014 AP RX Yes Yes ➤ 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

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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 ➤ 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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Paragraph IV (Patent) Challenges for COPAXONE
Drugname Dosage Strength RLD Date
➤ Subscribe Injection 40 mg/mL, 1 mL pre-filled syringe ➤ Subscribe ➤ Sign Up
➤ Subscribe Injection 40 mg/mL, 1 mL pre-filled syringe ➤ Subscribe ➤ Sign Up

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