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Last Updated: November 22, 2024

EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE - Generic Drug Details


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

Emtricitabine; tenofovir disoproxil fumarate is the generic ingredient in three branded drugs marketed by Hetero Labs Ltd Iii, Amneal Pharms Co, Apotex, Aurobindo Pharma, Aurobindo Pharma Ltd, Chartwell Rx, Cipla, Laurus, Macleods Pharms Ltd, Mylan, Strides Pharma, Teva Pharms Usa, Zydus Pharms, and Gilead, and is included in fourteen NDAs. There are four patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Emtricitabine; tenofovir disoproxil fumarate has sixty-two patent family members in twenty-nine countries.

Thirty-one suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Recent Clinical Trials for EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

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

SponsorPhase
Assistance Publique - Hôpitaux de ParisPhase 3
University College, LondonPhase 3
King's College LondonPhase 3

See all EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE clinical trials

Generic filers with tentative approvals for EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up200MG; 300MGTABLET; 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 EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
TRUVADA Tablets emtricitabine; tenofovir disoproxil fumarate 100 mg/150 mg 133 mg/200 mg 167 mg/250 mg 021752 1 2017-05-19
TRUVADA Tablets emtricitabine; tenofovir disoproxil fumarate 200 mg/300 mg 021752 1 2008-09-26

US Patents and Regulatory Information for 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
Chartwell Rx EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 204131-001 Jun 4, 2021 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Gilead TRUVADA emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021752-001 Aug 2, 2004 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Teva Pharms Usa EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 090894-001 Jun 8, 2017 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Zydus Pharms EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 212689-002 Jul 1, 2021 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Amneal Pharms Co EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 209721-003 Aug 22, 2018 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Strides Pharma EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 091055-001 Jan 13, 2021 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Gilead TRUVADA emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021752-001 Aug 2, 2004 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>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 EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

International Patents for EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Country Patent Number Title Estimated Expiration
Japan 2019052174 組み合わせ抗ウイルス治療のための組成物および方法 (COMPOSITION AND METHOD FOR COMBINATION ANTIVIRAL TREATMENT) ⤷  Sign Up
Israel 169243 PHARMACEUTICAL COMPOSITIONS FOR COMBINATION ANTIVIRAL THERAPY ⤷  Sign Up
Taiwan I355270 ⤷  Sign Up
Japan 2021004264 組み合わせ抗ウイルス治療のための組成物および方法 (COMPOSITION AND METHOD FOR COMBINATION ANTIVIRAL TREATMENT) ⤷  Sign Up
European Patent Office 1583542 COMPOSITIONS ET MÉTHODES DESTINÉES UNE THÉRAPIE DE COMBINAISON ANTIVIRALE (COMPOSITIONS AND METHODS FOR COMBINATION ANTIVIRAL THERAPY) ⤷  Sign Up
Poland 408254 Kompozycje i i sposoby wykorzystywane w skojarzonej terapii przeciwwirusowej (Compositions and methods used in combination for antiviral therapy) ⤷  Sign Up
South Africa 200505852 Compositions and methods for combination antiviraltherapy ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0513200 122004000015 Germany ⤷  Sign Up PRODUCT NAME: EMTRIVA-EMTRICITABINE; REGISTRATION NO/DATE: EU/1/03/261/001-003 20031024
3808743 301190 Netherlands ⤷  Sign Up PRODUCT NAME: EEN COMBINATIE VAN RILPIVIRINE OF EEN DOOR HET BASISOCTROOI BESCHERMDE THERAPEUTISCH EQUIVALENTE VORM DAARVAN, ZOALS EEN FARMACEUTISCH AANVAARDBAAR ADDITIEZOUT VAN RILPIVIRINE, MET INBEGRIP VAN HET HYDROCHLORIDE-ZOUT VAN RILPIVIRINE, EN EMTRICITABINE; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
3808743 CA 2022 00035 Denmark ⤷  Sign Up PRODUCT NAME: A COMBINATION OF RILPIVIRINE OR A THERAPEUTICALLY EQUIVALENT FORM THEREOF PROTECTED BY THE BASIC PATENT, SUCH AS A PHARMACEUTICALLY ACCEPTABLE ADDITION SALT OF RILPIVIRINE, INCLUDING THE HYDROCHLORIC ACID SALT OF RILPIVIRINE, AND EMTRICITABINE; REG. NO/DATE: EU/1/11/737/001-002 20111128
0915894 08C0020 France ⤷  Sign Up PRODUCT NAME: EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/07/430/001 20071213
1663240 2016/058 Ireland ⤷  Sign Up PRODUCT NAME: A COMBINATION OF: RILPIVIRINE OR A THERAPEUTICALLY EQUIVALENT FORM THEREOF PROTECTED BY THE BASIC PATENT, SUCH AS A PHARMACEUTICALLY ACCEPTABLE SALT OF RILPIVIRINE, INCLUDING THE HYDROCHLORIDE SALT OF RILPIVIRINE; EMTRICITABINE; AND TENOFOVIR ALAFENAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR TENOFOVIR ALAFENAMIDE FUMARATE.; NAT REGISTRATION NO/DATE: EU/1/16/1112 20160621; FIRST REGISTRATION NO/DATE: JOURNAL OF THE INTELLECTUAL PROPERTY OFFICE OF IRELAND (NO. 2457)
1663240 1590057-4 Sweden ⤷  Sign Up PRODUCT NAME: A COMBINATION OF RILPIVIRINE, OR A PHARMACEUTICAL LY ACCEPTABLE SALT OF RILPIVIRINE, INCLUDING THE HYDROCHLORIDE SALT OF RILPIVIRINE, AND TENOFOVIR DISOPROXIL, IN PARTICULAR TENOFOVIR DISOPROXIL FUMARATE, AND EMTRICITABINE; REG. NO/DATE: EU/1/11/737 20111128
1663240 2015/053 Ireland ⤷  Sign Up PRODUCT NAME: A COMBINATION OF RILPIVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING THE HYDROCHLORIDE SALT, TENOFOVIR, IN PARTICULAR TENOFOVIR DISOPROXIL FUMARATE, AND EMTRICITABINE; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
>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.