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Medtronic
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Cipla
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Deloitte
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Generated: February 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021937

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NDA 021937 describes ATRIPLA, which is a drug marketed by Gilead and is included in one NDA. It is available from six suppliers. There are sixteen patents protecting this drug and one Paragraph IV challenge. Additional details are available on the ATRIPLA profile page.

The generic ingredient in ATRIPLA is efavirenz; emtricitabine; tenofovir disoproxil fumarate. 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; emtricitabine; tenofovir disoproxil fumarate profile page.
Summary for 021937
Tradename:ATRIPLA
Applicant:Gilead
Ingredient:efavirenz; emtricitabine; tenofovir disoproxil fumarate
Patents:16
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 021937
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ATRIPLA efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021937 NDA Gilead Sciences, LLC 15584-0101 N 15584-0101-1
ATRIPLA efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021937 NDA A-S Medication Solutions 50090-0980 N 50090-0980-0

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength600MG;200MG;300MG
Approval Date:Jul 12, 2006TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Jan 2, 2018Product Flag?Substance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Jan 25, 2018Product Flag?Substance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Jan 25, 2018Product Flag?Substance Flag?Delist Request?

Expired US Patents for NDA 021937

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gilead ATRIPLA efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021937-001 Jul 12, 2006 ➤ Sign Up ➤ Sign Up
Gilead ATRIPLA efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021937-001 Jul 12, 2006 ➤ Sign Up ➤ Sign Up
Gilead ATRIPLA efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021937-001 Jul 12, 2006 ➤ Sign Up ➤ Sign Up
Gilead ATRIPLA efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021937-001 Jul 12, 2006 ➤ Sign Up ➤ Sign Up
Gilead ATRIPLA efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021937-001 Jul 12, 2006 ➤ Sign Up ➤ Sign Up
Gilead ATRIPLA efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021937-001 Jul 12, 2006 ➤ Sign Up ➤ Sign Up
Gilead ATRIPLA efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021937-001 Jul 12, 2006 ➤ Sign Up ➤ Sign Up
Gilead ATRIPLA efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021937-001 Jul 12, 2006 ➤ Sign Up ➤ Sign Up
Gilead ATRIPLA efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021937-001 Jul 12, 2006 ➤ Sign Up ➤ Sign Up
Gilead ATRIPLA efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021937-001 Jul 12, 2006 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Mallinckrodt
US Department of Justice
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Johnson and Johnson
Harvard Business School
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Covington

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