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Last Updated: March 19, 2024

Efavirenz; emtricitabine; tenofovir disoproxil fumarate - Generic Drug Details


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What are the generic drug sources for efavirenz; emtricitabine; tenofovir disoproxil fumarate and what is the scope of freedom to operate?

Efavirenz; emtricitabine; tenofovir disoproxil fumarate is the generic ingredient in three branded drugs marketed by Gilead Sciences, Aurobindo Pharma, Cipla, Hetero Labs Ltd V, Laurus, Macleods Pharms Ltd, Teva Pharms Usa, and Strides Pharma, and is included in eight NDAs. There are seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Efavirenz; emtricitabine; tenofovir disoproxil fumarate has one hundred and twenty-three patent family members in thirty-one countries.

Eight suppliers are listed for this compound. There are two tentative approvals for this compound.

Recent Clinical Trials for efavirenz; emtricitabine; tenofovir disoproxil fumarate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Centre de Recherches et d'Etude sur la Pathologie Tropicale et le SidaN/A
Yu-Jay Corp.Phase 3
University of AlbertaPhase 4

See all efavirenz; emtricitabine; tenofovir disoproxil fumarate clinical trials

Generic filers with tentative approvals for EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial600MG; 200MG; 300MGTABLET; ORAL
⤷  Try a Trial⤷  Try a Trial300MGTABLET; ORAL
⤷  Try a Trial⤷  Try a Trial200MGTABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Paragraph IV (Patent) Challenges for EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
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 efavirenz; emtricitabine; tenofovir disoproxil fumarate

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 Y ⤷  Try a Trial
Aurobindo Pharma EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 203041-001 Sep 4, 2018 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  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 efavirenz; emtricitabine; tenofovir disoproxil fumarate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gilead Sciences ATRIPLA efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021937-001 Jul 12, 2006 ⤷  Try a Trial ⤷  Try a Trial
Gilead Sciences ATRIPLA efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021937-001 Jul 12, 2006 ⤷  Try a Trial ⤷  Try a Trial
Gilead Sciences ATRIPLA efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021937-001 Jul 12, 2006 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for efavirenz; emtricitabine; tenofovir disoproxil fumarate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0582455 2001C/001 Belgium ⤷  Try a Trial PRODUCT NAME: EFAVIRENZ; NATL. REGISTRATION NO/DATE: EU/1/99/110/001 19990604; FIRST REGISTRATION: CH 54908 01 19981120
0582455 08C0021 France ⤷  Try a Trial PRODUCT NAME: EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/07/430/001 20071213
0915894 SPC/GB08/033 United Kingdom ⤷  Try a Trial 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
>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.