Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Generated: July 22, 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 glatiramer acetate 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-three patent family members in thirty-two countries.

There are five drug master file entries for glatiramer acetate. Three suppliers are listed for this compound.

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

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 091646-001 Oct 3, 2017 AP RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Teva Pharms Usa COPAXONE glatiramer acetate INJECTABLE;SUBCUTANEOUS 020622-003 Jan 28, 2014 AP RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Teva Pharms Usa COPAXONE glatiramer acetate INJECTABLE;SUBCUTANEOUS 020622-002 Feb 12, 2002 AP RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Sandoz Inc GLATOPA glatiramer acetate INJECTABLE;SUBCUTANEOUS 090218-001 Apr 16, 2015 AP RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Teva Pharms Usa COPAXONE glatiramer acetate INJECTABLE;SUBCUTANEOUS 020622-003 Jan 28, 2014 AP RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Sandoz Inc GLATOPA glatiramer acetate INJECTABLE;SUBCUTANEOUS 206921-001 Feb 12, 2018 AP RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Teva Pharms Usa COPAXONE glatiramer acetate INJECTABLE;SUBCUTANEOUS 020622-003 Jan 28, 2014 AP RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
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 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 ➤ Try a Free Trial ➤ Try a Free Trial
Teva Pharms Usa COPAXONE glatiramer acetate INJECTABLE;SUBCUTANEOUS 020622-002 Feb 12, 2002 ➤ Try a Free Trial ➤ Try a Free Trial
Teva Pharms Usa COPAXONE glatiramer acetate INJECTABLE;SUBCUTANEOUS 020622-002 Feb 12, 2002 ➤ Try a Free Trial ➤ Try a Free Trial
Teva Pharms Usa COPAXONE glatiramer acetate INJECTABLE;SUBCUTANEOUS 020622-003 Jan 28, 2014 ➤ Try a Free Trial ➤ Try a Free Trial
Teva Pharms Usa COPAXONE glatiramer acetate FOR SOLUTION;SUBCUTANEOUS 020622-001 Dec 20, 1996 ➤ Try a Free Trial ➤ Try a Free Trial
Teva Pharms Usa COPAXONE glatiramer acetate INJECTABLE;SUBCUTANEOUS 020622-002 Feb 12, 2002 ➤ Try a Free Trial ➤ Try a Free Trial
Teva Pharms Usa COPAXONE glatiramer acetate INJECTABLE;SUBCUTANEOUS 020622-003 Jan 28, 2014 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.