Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

US Army
Farmers Insurance
Argus Health
UBS
Baxter
Chubb
McKinsey
Moodys
Colorcon

Generated: April 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020622

« 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. There are five patents protecting this drug and two Paragraph IV challenges. Additional details are available on the COPAXONE profile page.

The generic ingredient in COPAXONE is glatiramer acetate. There are four 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:5
Therapeutic Class:Immunological Agents
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 N 68546-317-00
COPAXONE glatiramer acetate INJECTABLE;SUBCUTANEOUS 020622 NDA Teva Neuroscience, Inc. 68546-317 N 68546-317-00

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
Patent:➤ Try a Free TrialPatent Expiration:Aug 19, 2030Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING MS BY ADMINISTERING COPAXONE

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 020622-002 Feb 12, 2002 ➤ 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 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
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Teva
Cerilliant
Moodys
Covington
US Department of Justice
Express Scripts
Harvard Business School
Chinese Patent Office
Cipla

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.