➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Medtronic
McKinsey
Moodys
Express Scripts
Colorcon
Mallinckrodt

Last Updated: August 12, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021937

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

NDA 021937 describes ATRIPLA, which is a drug marketed by Gilead Sciences and is included in one NDA. It is available from two 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. Two 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 REMEDYREPACK INC. 70518-0341 70518-0341-0 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-0341-0)
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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Merck
Boehringer Ingelheim
Johnson and Johnson
Baxter
Moodys
Dow

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 verification 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.