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Last Updated: May 16, 2022

ATRIPLA Drug Patent Profile


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When do Atripla patents expire, and when can generic versions of Atripla launch?

Atripla is a drug marketed by Gilead Sciences and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and twenty-five patent family members in thirty-one countries.

The generic ingredient in ATRIPLA is efavirenz; emtricitabine; tenofovir disoproxil fumarate. There are twenty-six drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the efavirenz; emtricitabine; tenofovir disoproxil fumarate profile page.

DrugPatentWatch® Generic Entry Outlook for Atripla

Atripla was eligible for patent challenges on July 2, 2007.

There have been eighteen patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There are two tentative approvals for the generic drug (efavirenz; emtricitabine; tenofovir disoproxil fumarate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Drug patent expirations by year for ATRIPLA
Drug Prices for ATRIPLA

See drug prices for ATRIPLA

Paragraph IV (Patent) Challenges for ATRIPLA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ATRIPLA Tablets efavirenz; emtricitabine; tenofovir disoproxil fumarate 600 mg/200 mg/ 300 mg 021937 1 2008-12-29

US Patents and Regulatory Information for ATRIPLA

ATRIPLA is protected by ten US patents.

Patents protecting ATRIPLA

Compositions and methods for combination antiviral therapy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER

Compositions and methods for combination antiviral therapy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HIV-1 INFECTION IN ADULTS

Unitary pharmaceutical dosage form
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Compositions and methods for combination antiviral therapy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HIV INFECTION

Unitary pharmaceutical dosage form
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HIV-1 INFECTION IN ADULTS

Unitary pharmaceutical dosage form
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER

Compositions and methods for combination antiviral therapy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HIV INFECTION

Unitary pharmaceutical dosage form
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER

Unitary pharmaceutical dosage form
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HIV-1 INFECTION IN ADULTS

Compositions and methods for combination antiviral therapy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HIV INFECTION

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Gilead Sciences ATRIPLA efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021937-001 Jul 12, 2006 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Gilead Sciences ATRIPLA efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021937-001 Jul 12, 2006 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Gilead Sciences ATRIPLA efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021937-001 Jul 12, 2006 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Gilead Sciences ATRIPLA efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021937-001 Jul 12, 2006 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Gilead Sciences ATRIPLA efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021937-001 Jul 12, 2006 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Gilead Sciences ATRIPLA efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021937-001 Jul 12, 2006 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for ATRIPLA

International Patents for ATRIPLA

When does loss-of-exclusivity occur for ATRIPLA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

African Regional IP Organization (ARIPO)

Patent: 89
Estimated Expiration: See Plans and Pricing

Argentina

Patent: 0805
Estimated Expiration: See Plans and Pricing

Patent: 3332
Estimated Expiration: See Plans and Pricing

Patent: 1679
Estimated Expiration: See Plans and Pricing

Australia

Patent: 04206821
Estimated Expiration: See Plans and Pricing

Patent: 04206827
Estimated Expiration: See Plans and Pricing

Patent: 09200414
Estimated Expiration: See Plans and Pricing

Austria

Patent: 8455
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0406760
Estimated Expiration: See Plans and Pricing

Canada

Patent: 12319
Estimated Expiration: See Plans and Pricing

Patent: 12475
Estimated Expiration: See Plans and Pricing

China

Patent: 38628
Estimated Expiration: See Plans and Pricing

Patent: 2670629
Estimated Expiration: See Plans and Pricing

Patent: 5596356
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0050619
Estimated Expiration: See Plans and Pricing

Patent: 0140379
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 08355
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 83542
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 5145
Estimated Expiration: See Plans and Pricing

Patent: 0501134
Estimated Expiration: See Plans and Pricing

Patent: 1100293
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 83542
Estimated Expiration: See Plans and Pricing

Patent: 85527
Estimated Expiration: See Plans and Pricing

Patent: 23063
Estimated Expiration: See Plans and Pricing

Patent: 25718
Estimated Expiration: See Plans and Pricing

Germany

Patent: 2004014470
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 79122
Estimated Expiration: See Plans and Pricing

Iceland

Patent: 77
Estimated Expiration: See Plans and Pricing

Israel

Patent: 9243
Estimated Expiration: See Plans and Pricing

Japan

Patent: 96241
Estimated Expiration: See Plans and Pricing

Patent: 06515624
Estimated Expiration: See Plans and Pricing

Patent: 06516570
Estimated Expiration: See Plans and Pricing

Patent: 10120957
Estimated Expiration: See Plans and Pricing

Patent: 14037430
Estimated Expiration: See Plans and Pricing

Patent: 15098488
Estimated Expiration: See Plans and Pricing

Patent: 17057232
Estimated Expiration: See Plans and Pricing

Patent: 19052174
Estimated Expiration: See Plans and Pricing

Patent: 21004264
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 05007016
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 0728
Estimated Expiration: See Plans and Pricing

Norway

Patent: 7917
Estimated Expiration: See Plans and Pricing

Patent: 0951
Estimated Expiration: See Plans and Pricing

Patent: 053817
Estimated Expiration: See Plans and Pricing

Patent: 150656
Estimated Expiration: See Plans and Pricing

Patent: 160777
Estimated Expiration: See Plans and Pricing

Patent: 171193
Estimated Expiration: See Plans and Pricing

Poland

Patent: 8368
Estimated Expiration: See Plans and Pricing

Patent: 8254
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 83542
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 83542
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 0505852
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 0860136
Estimated Expiration: See Plans and Pricing

Patent: 050092755
Estimated Expiration: See Plans and Pricing

Patent: 080032014
Estimated Expiration: See Plans and Pricing

Patent: 090053867
Estimated Expiration: See Plans and Pricing

Spain

Patent: 08136
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 55270
Estimated Expiration: See Plans and Pricing

Patent: 0423946
Estimated Expiration: See Plans and Pricing

Patent: 0425895
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 797
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ATRIPLA around the world.

Country Patent Number Title Estimated Expiration
Japan 2013213071 NUCLEOTIDE ANALOG COMPOSITION AND SYNTHESIS METHOD See Plans and Pricing
Norway 324979 See Plans and Pricing
Spain 2537164 See Plans and Pricing
Germany 69829010 See Plans and Pricing
Slovenia 1243593 See Plans and Pricing
South Korea 100573192 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ATRIPLA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0582455 2008/016 Ireland See Plans and Pricing PRODUCT NAME: A COMBINATION OF EFAVIRENZ AND EMTRICTABINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/07/430/001 20071213
0582455 SPC/GB08/022 United Kingdom See Plans and Pricing PRODUCT NAME: A COMBINATION OF EFAVIRENZ, EMTRICITABINE OR A PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER THEREOF, AND TENOFOVIR OR A PHARMACEUTICALLY ACCEPTABLE PRODRUG, SALT OR ESTER THEREOF, PARTICULARLY TENOFOVIR DISOPROXIL, ESPECIALLY TENOFOVIR DISOPROXIL FUMARATE; REGISTERED: UK EU/1/07/430/001 20071213
0915894 SPC/GB08/033 United Kingdom See Plans and Pricing PRODUCT NAME: TENOFOVIR DISOPROXIL AND THE SALTS (IN PARTICULAR THE FUMARATE), HYDRATES, TAUTOMERS AND SOLVATES THEREOF, TOGETHER WITH EMTRICITABINE AND EFAVIRENZ; REGISTERED: UK EU/1/07/430/001 20071213; REASON FOR LAPSE: SURRENDERED
0582455 CA 2001 00014 Denmark See Plans and Pricing
0915894 05C0032 France See Plans and Pricing PRODUCT NAME: TENOFOVIR DISOPROXIL FUMARATE; EMTRICITABINE; REGISTRATION NO/DATE: EU/1/04/305/001 20050221
0915894 CA 2005 00032 Denmark See Plans and Pricing
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Medtronic
McKinsey
AstraZeneca
Dow
Express Scripts
Baxter

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.