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Serving 500+ biopharmaceutical companies globally:

Colorcon
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US Department of Justice
Argus Health
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Generated: July 25, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020839

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NDA 020839 describes PLAVIX, which is a drug marketed by Sanofi Aventis Us and is included in one NDA. It is available from ten suppliers. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the PLAVIX profile page.

The generic ingredient in PLAVIX is clopidogrel bisulfate. There are fifty-three drug master file entries for this compound. Fifty-one suppliers are listed for this compound. Additional details are available on the clopidogrel bisulfate profile page.

Summary for NDA: 020839

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Blood Products/Modifiers/ Volume Expanders
Formulation / Manufacturing:see details

Pharmacology for NDA: 020839

Suppliers and Packaging for NDA: 020839

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PLAVIX
clopidogrel bisulfate
TABLET;ORAL 020839 NDA STAT RX USA LLC 16590-288 16590-288-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16590-288-30)
PLAVIX
clopidogrel bisulfate
TABLET;ORAL 020839 NDA STAT RX USA LLC 16590-288 16590-288-60 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16590-288-60)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 75MG BASE
Approval Date:Nov 17, 1997TE:ABRLD:Yes
Patent:► SubscribePatent Expiration:Dec 10, 2019Product Flag?Substance Flag?Delist Request?Y
Patent:► SubscribePatent Expiration:Dec 10, 2019Product Flag?Substance Flag?Delist Request?Y

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 300MG BASE
Approval Date:Sep 20, 2007TE:ABRLD:Yes
Patent:► SubscribePatent Expiration:Dec 10, 2019Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 020839

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us
PLAVIX
clopidogrel bisulfate
TABLET;ORAL020839-001Nov 17, 1997► Subscribe► Subscribe
Sanofi Aventis Us
PLAVIX
clopidogrel bisulfate
TABLET;ORAL020839-001Nov 17, 1997► Subscribe► Subscribe
Sanofi Aventis Us
PLAVIX
clopidogrel bisulfate
TABLET;ORAL020839-002Sep 20, 2007► Subscribe► Subscribe
Sanofi Aventis Us
PLAVIX
clopidogrel bisulfate
TABLET;ORAL020839-001Nov 17, 1997► Subscribe► Subscribe
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Serving 500+ biopharmaceutical companies globally:

McKesson
Medtronic
Citi
Fuji
US Department of Justice
Federal Trade Commission
McKinsey
Chinese Patent Office
Covington
AstraZeneca

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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