Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 7, 2019

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 Sciences and is included in one NDA. It is available from four suppliers. There are nine 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. Four suppliers are listed for this compound. Additional details are available on the efavirenz; emtricitabine; tenofovir disoproxil fumarate profile page.
Summary for 021937
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 15584-0101-1 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (15584-0101-1)
ATRIPLA efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021937 NDA A-S Medication Solutions 50090-0980 50090-0980-0 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-0980-0)
Paragraph IV (Patent) Challenges for 021937
Tradename Dosage Ingredient NDA Submissiondate
ATRIPLA TABLET;ORAL efavirenz; emtricitabine; tenofovir disoproxil fumarate 021937 2008-12-29

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength600MG;200MG;300MG
Approval Date:Jul 12, 2006TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:May 4, 2021Product Flag?Substance Flag?Delist Request?Y
Patent:  Start TrialPatent Expiration:Sep 9, 2021Product Flag?Substance Flag?Delist Request?Y
Patent:  Start TrialPatent Expiration:Jan 13, 2024Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF HIV-1 INFECTION IN ADULTS

Expired US Patents for NDA 021937

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Serving leading biopharmaceutical companies globally:

Medtronic
Harvard Business School
Moodys
Dow
Mallinckrodt
Colorcon

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