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Last Updated: July 4, 2020

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Details for New Drug Application (NDA): 020622


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NDA 020622 describes COPAXONE, which is a drug marketed by Teva Pharms Usa and is included in one NDA. It is available from one supplier. Additional details are available on the COPAXONE profile page.

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.
Summary for 020622
Tradename:COPAXONE
Applicant:Teva Pharms Usa
Ingredient:glatiramer acetate
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 020622
Suppliers and Packaging for NDA: 020622
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
COPAXONE glatiramer acetate FOR SOLUTION;SUBCUTANEOUS 020622 NDA Teva Neuroscience, Inc. 68546-317 68546-317-30 30 BLISTER PACK in 1 CARTON (68546-317-30) > 1 SYRINGE, GLASS in 1 BLISTER PACK > 1 mL in 1 SYRINGE, GLASS
COPAXONE glatiramer acetate FOR SOLUTION;SUBCUTANEOUS 020622 NDA Teva Neuroscience, Inc. 68546-325 68546-325-06 6 BLISTER PACK in 1 CARTON (68546-325-06) > 1 SYRINGE, GLASS in 1 BLISTER PACK > 1 mL in 1 SYRINGE, GLASS
Paragraph IV (Patent) Challenges for 020622
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

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:FOR SOLUTION;SUBCUTANEOUSStrength20MG/VIAL
Approval Date:Dec 20, 1996TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrength20MG/ML
Approval Date:Feb 12, 2002TE:APRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrength40MG/ML
Approval Date:Jan 28, 2014TE:APRLD:Yes

Expired US Patents for NDA 020622

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   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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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