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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Moodys
Farmers Insurance
Chinese Patent Office
Daiichi Sankyo
Citi
Fish and Richardson
QuintilesIMS
Merck

Generated: April 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021360

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NDA 021360 describes SUSTIVA, which is a drug marketed by Bristol Myers Squibb and is included in two NDAs. It is available from two suppliers. There are four patents protecting this drug and two Paragraph IV challenges. Additional details are available on the SUSTIVA profile page.

The generic ingredient in SUSTIVA is efavirenz. There are twenty-six drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the efavirenz profile page.
Summary for 021360
Tradename:SUSTIVA
Applicant:Bristol Myers Squibb
Ingredient:efavirenz
Patents:2
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 021360
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SUSTIVA efavirenz TABLET;ORAL 021360 NDA Bristol-Myers Squibb Pharma Company 0056-0510 N 0056-0510-30
SUSTIVA efavirenz TABLET;ORAL 021360 NDA REMEDYREPACK INC. 70518-0482 N 70518-0482-0

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength300MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Feb 1, 2002TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Aug 14, 2018Product Flag?Substance Flag?Delist Request?Y
Patent:➤ Try a Free TrialPatent Expiration:Jul 20, 2018Product Flag?Substance Flag?Delist Request?Y

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength600MG
Approval Date:Feb 1, 2002TE:ABRLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Aug 14, 2018Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 021360

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bristol Myers Squibb SUSTIVA efavirenz TABLET;ORAL 021360-002 Feb 1, 2002 ➤ Try a Free Trial ➤ Try a Free Trial
Bristol Myers Squibb SUSTIVA efavirenz TABLET;ORAL 021360-001 Feb 1, 2002 ➤ Try a Free Trial ➤ Try a Free Trial
Bristol Myers Squibb SUSTIVA efavirenz TABLET;ORAL 021360-001 Feb 1, 2002 ➤ Try a Free Trial ➤ Try a Free Trial
Bristol Myers Squibb SUSTIVA efavirenz TABLET;ORAL 021360-001 Feb 1, 2002 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
US Army
McKesson
Covington
Moodys
Accenture
Baxter
Cipla
Federal Trade Commission

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