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Last Updated: March 3, 2024

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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-three 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. Eight 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

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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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF HIV-1 INFECTION IN ADULTS

Unitary pharmaceutical dosage form
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Compositions and methods for combination antiviral therapy
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF HIV INFECTION

Unitary pharmaceutical dosage form
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF HIV-1 INFECTION IN ADULTS

Unitary pharmaceutical dosage form
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF HIV INFECTION

Unitary pharmaceutical dosage form
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER

Unitary pharmaceutical dosage form
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF HIV-1 INFECTION IN ADULTS

Compositions and methods for combination antiviral therapy
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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 ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Gilead Sciences ATRIPLA efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021937-001 Jul 12, 2006 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Gilead Sciences ATRIPLA efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021937-001 Jul 12, 2006 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Gilead Sciences ATRIPLA efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021937-001 Jul 12, 2006 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Gilead Sciences ATRIPLA efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021937-001 Jul 12, 2006 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Gilead Sciences ATRIPLA efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021937-001 Jul 12, 2006 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Gilead Sciences ATRIPLA efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021937-001 Jul 12, 2006 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>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

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

Country Patent Number Title Estimated Expiration
Canada 2611523 FORME POSOLOGIQUE PHARMACEUTIQUE UNITAIRE (STABLE FIXED-DOSE UNITARY FORMULATIONS CONTAINING TENOFOVIR, A SURFACTANT, EFAVIRENZ AND EMTRICITABINE) ⤷  Try a Trial
Luxembourg 91446 ⤷  Try a Trial
Hungary 211300 ⤷  Try a Trial
Japan 3292830 ⤷  Try a Trial
Norway 325824 ⤷  Try a Trial
South Korea 20000029705 ⤷  Try a Trial
Norway 313048 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ATRIPLA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0582455 CA 2001 00014 Denmark ⤷  Try a Trial
0915894 SPC/GB05/041 United Kingdom ⤷  Try a Trial SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB05/041 GRANTED TO GILEAD SCIENCES, INC. IN RESPECT OF THE PRODUCT COMPOSITION CONTAINING BOTH TENOFOVIR DISOPROXIL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE, TAUTOMER OR SOLVATE THEREOF, TOGETHER WITH EMTRICITABINE , THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6233 DATED 05/11/2008 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 23/02/2020.
0582455 SPC/GB08/022 United Kingdom ⤷  Try a Trial 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
0513200 300148 Netherlands ⤷  Try a Trial 300148, 20110131, EXPIRES: 20160130
0915894 SPC018/2008 Ireland ⤷  Try a Trial SPC018/2008: 20090811, EXPIRES: 20220724
0582455 40/2000 Austria ⤷  Try a Trial PRODUCT NAME: EFAVIRENZ, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES; NAT. REGISTRATION NO/DATE: EU/1/99/110/001-004 1/99/111/001-004 19990528; FIRST REGISTRATION: LI 54908 01, 54908 02, 54908 03 19981120
0582455 08C0021 France ⤷  Try a Trial PRODUCT NAME: EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/07/430/001 20071213
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.