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Novartis
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McKesson
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McKinsey
US Army
Baxter
AstraZeneca
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Generated: October 20, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020972

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NDA 020972 describes SUSTIVA, which is a drug marketed by Bristol Myers Squibb and is included in two NDAs. It is available from three 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-five drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the efavirenz profile page.

Summary for NDA: 020972

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:4
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 020972

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SUSTIVA
efavirenz
CAPSULE;ORAL 020972 NDA Bristol-Myers Squibb Pharma Company 0056-0470 0056-0470-30 30 CAPSULE, GELATIN COATED in 1 BOTTLE (0056-0470-30)
SUSTIVA
efavirenz
CAPSULE;ORAL 020972 NDA Bristol-Myers Squibb Pharma Company 0056-0474 0056-0474-92 90 CAPSULE, GELATIN COATED in 1 BOTTLE (0056-0474-92)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength50MG
Approval Date:Sep 17, 1998TE:RLD:Yes
Regulatory Exclusivity Expiration:Nov 2, 2016
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY
Patent:► SubscribePatent Expiration:Oct 6, 2019Product Flag?Substance Flag?Delist Request?Y
Patent:► SubscribePatent Expiration:Oct 6, 2019Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 020972

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bristol Myers Squibb
SUSTIVA
efavirenz
CAPSULE;ORAL020972-003Sep 17, 1998► Subscribe► Subscribe
Bristol Myers Squibb
SUSTIVA
efavirenz
CAPSULE;ORAL020972-002Sep 17, 1998► Subscribe► Subscribe
Bristol Myers Squibb
SUSTIVA
efavirenz
CAPSULE;ORAL020972-001Sep 17, 1998► Subscribe► Subscribe
Bristol Myers Squibb
SUSTIVA
efavirenz
CAPSULE;ORAL020972-002Sep 17, 1998► Subscribe► Subscribe
Bristol Myers Squibb
SUSTIVA
efavirenz
CAPSULE;ORAL020972-003Sep 17, 1998► Subscribe► Subscribe
Bristol Myers Squibb
SUSTIVA
efavirenz
CAPSULE;ORAL020972-003Sep 17, 1998► Subscribe► Subscribe
Bristol Myers Squibb
SUSTIVA
efavirenz
CAPSULE;ORAL020972-001Sep 17, 1998► Subscribe► Subscribe
Bristol Myers Squibb
SUSTIVA
efavirenz
CAPSULE;ORAL020972-002Sep 17, 1998► Subscribe► Subscribe
Bristol Myers Squibb
SUSTIVA
efavirenz
CAPSULE;ORAL020972-001Sep 17, 1998► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

QuintilesIMS
AstraZeneca
Express Scripts
Baxter
Fish and Richardson
Fuji
Colorcon
Daiichi Sankyo
Deloitte
Cerilliant

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