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Serving leading biopharmaceutical companies globally:

Queensland Health
Healthtrust
Federal Trade Commission
Covington
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Deloitte
Dow
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Generated: November 24, 2017

DrugPatentWatch Database Preview

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. 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:
1
Applicant:
1
Ingredient:
1
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 68546-317-00 14 BLISTER PACK in 1 CARTON (68546-317-00) > 1 SYRINGE, GLASS in 1 BLISTER PACK > 1 mL in 1 SYRINGE, GLASS
COPAXONE
glatiramer acetate
INJECTABLE;SUBCUTANEOUS 020622 NDA Teva Neuroscience, Inc. 68546-317 68546-317-00 14 BLISTER PACK in 1 CARTON (68546-317-00) > 1 SYRINGE, GLASS in 1 BLISTER PACK > 1 mL in 1 SYRINGE, GLASS

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrength40MG/ML
Approval Date:Jan 28, 2014TE:APRLD:Yes
Regulatory Exclusivity Expiration:Jan 28, 2017
Regulatory Exclusivity Use:NEW PRODUCT

Expired Orange Book Patents for NDA: 020622

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Teva Pharms Usa
COPAXONE
glatiramer acetate
INJECTABLE;SUBCUTANEOUS020622-003Jan 28, 2014► Subscribe► Subscribe
Teva Pharms Usa
COPAXONE
glatiramer acetate
INJECTABLE;SUBCUTANEOUS020622-002Feb 12, 2002► Subscribe► Subscribe
Teva Pharms Usa
COPAXONE
glatiramer acetate
INJECTABLE;SUBCUTANEOUS020622-002Feb 12, 2002► Subscribe► Subscribe
Teva Pharms Usa
COPAXONE
glatiramer acetate
FOR SOLUTION;SUBCUTANEOUS020622-001Dec 20, 1996► Subscribe► Subscribe
Teva Pharms Usa
COPAXONE
glatiramer acetate
INJECTABLE;SUBCUTANEOUS020622-003Jan 28, 2014► Subscribe► Subscribe
Teva Pharms Usa
COPAXONE
glatiramer acetate
FOR SOLUTION;SUBCUTANEOUS020622-001Dec 20, 1996► Subscribe► Subscribe
Teva Pharms Usa
COPAXONE
glatiramer acetate
FOR SOLUTION;SUBCUTANEOUS020622-001Dec 20, 1996► Subscribe► Subscribe
Teva Pharms Usa
COPAXONE
glatiramer acetate
INJECTABLE;SUBCUTANEOUS020622-003Jan 28, 2014► Subscribe► Subscribe
Teva Pharms Usa
COPAXONE
glatiramer acetate
INJECTABLE;SUBCUTANEOUS020622-002Feb 12, 2002► Subscribe► Subscribe
Teva Pharms Usa
COPAXONE
glatiramer acetate
FOR SOLUTION;SUBCUTANEOUS020622-001Dec 20, 1996► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Merck
McKinsey
Fuji
Deloitte
Cantor Fitzgerald
Chinese Patent Office
US Army
Cipla
Healthtrust
Covington

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.

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