You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 25, 2024

Details for New Drug Application (NDA): 020622


✉ Email this page to a colleague

« Back to Dashboard


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. Four 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
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

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:FOR SOLUTION;SUBCUTANEOUSStrength20MG/VIAL
Approval Date:Dec 20, 1996TE:RLD:Yes

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 FOR SOLUTION;SUBCUTANEOUS 020622-001 Dec 20, 1996 7,199,098 ⤷  Subscribe
Teva Pharms Usa COPAXONE glatiramer acetate INJECTABLE;SUBCUTANEOUS 020622-003 Jan 28, 2014 6,362,161 ⤷  Subscribe
Teva Pharms Usa COPAXONE glatiramer acetate INJECTABLE;SUBCUTANEOUS 020622-003 Jan 28, 2014 6,054,430 ⤷  Subscribe
Teva Pharms Usa COPAXONE glatiramer acetate FOR SOLUTION;SUBCUTANEOUS 020622-001 Dec 20, 1996 5,981,589 ⤷  Subscribe
Teva Pharms Usa COPAXONE glatiramer acetate INJECTABLE;SUBCUTANEOUS 020622-002 Feb 12, 2002 6,362,161 ⤷  Subscribe
Teva Pharms Usa COPAXONE glatiramer acetate INJECTABLE;SUBCUTANEOUS 020622-002 Feb 12, 2002 6,342,476 ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

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 verification 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.