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Last Updated: May 12, 2021

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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 two branded drugs marketed by Amneal Pharms Co, Aurobindo Pharma Ltd, Cipla, Laurus Labs Ltd, Macleods Pharms Ltd, Mylan, Strides Pharma, Teva Pharms Usa, Zydus Pharms, and Gilead, and is included in ten NDAs. There are six 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 two hundred and thirty-eight patent family members in forty-two countries.

There are eighteen drug master file entries for emtricitabine; tenofovir disoproxil fumarate. Twenty suppliers are listed for this compound. There are four tentative approvals for this compound.

Recent Clinical Trials for EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

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

SponsorPhase
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)Phase 3
ColsanitasPhase 2/Phase 3
Hospital Universitario Nacional de ColombiaPhase 2/Phase 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
  Get Started for $10  Get Started for $10200MG; 300MGTABLET; ORAL
  Get Started for $10  Get Started for $10200MG; 300MGTABLET; ORAL
  Get Started for $10  Get Started for $10200MG; 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 NDA Submissiondate
TRUVADA TABLET;ORAL emtricitabine; tenofovir disoproxil fumarate 021752 2017-05-19
TRUVADA TABLET;ORAL emtricitabine; tenofovir disoproxil fumarate 021752 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
Mylan EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 206436-001 Apr 9, 2018 AB RX No No   Get Started for $10   Get Started for $10   Get Started for $10
Aurobindo Pharma Ltd EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 090513-001 Jan 26, 2018 AB RX No No   Get Started for $10   Get Started for $10   Get Started for $10
Teva Pharms Usa EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 090894-001 Jun 8, 2017 AB RX No No   Get Started for $10   Get Started for $10   Get Started for $10
Gilead TRUVADA emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021752-003 Mar 10, 2016 AB RX Yes No   Get Started for $10   Get Started for $10   Get Started for $10
Macleods Pharms Ltd EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 203442-001 May 15, 2020 AB RX No No   Get Started for $10   Get Started for $10   Get Started for $10
Cipla EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 090958-001 Apr 2, 2021 AB RX No No   Get Started for $10   Get Started for $10   Get Started for $10
Gilead TRUVADA emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021752-001 Aug 2, 2004 AB RX Yes Yes   Get Started for $10   Get Started for $10 Y   Get Started for $10
>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 Estimated Expiration
Austria 398455   Get Started for $10
Canada 2513440   Get Started for $10
Finland 20060622   Get Started for $10
Australia 2002300661   Get Started for $10
Austria 469147   Get Started for $10
Japan 2014037430   Get Started for $10
Japan 2001352997   Get Started for $10
>Country >Patent Number >Estimated Expiration

Supplementary Protection Certificates for EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1663240 15C0071 France   Get Started for $10 PRODUCT NAME: COMBINAISON DE RILPIVIRINE OU SES FORMES THERAPEUTIQUEMENT EQUIVALENTES PROTEGEES PAR LE BREVET DE BASE TELLES QUE LES SELS PHARMACEUTIQUEMENT ACCEPTABLES DE RILPIVIRINE Y COMPRIS LE SEL D'ACIDE CHLORHYDRIQUE DE RILPIVIRINE AINSI QUE D'EMTRICITABINE; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
0513200 C00513200/01 Switzerland   Get Started for $10 PRODUCT NAME: EMTRICITABINE; REGISTRATION NUMBER/DATE: SWISSMEDIC 56880 25.10.2004
0513200 7/2004 Austria   Get Started for $10 PRODUCT NAME: EMTRICITABIN; NAT. REGISTRATION NO/DATE: EU/1/03/261/001- EU/1/03/261/003 20031024; FIRST REGISTRATION: EU EU/1/03/261/003
1663240 300851 Netherlands   Get Started for $10 PRODUCT NAME: COMBINATIE VAN: - RILPIVIRINE OF EEN THERAPEUTISCH EQUIVALENTE VORM DAARVAN ZOALS BESCHERMD DOOR HET BASISOCTROOI, ZOALS EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN RILPIVIRINE, WAARONDER HET HYDROCHLORIDEZOUT VAN RILPIVIRINE; - EMTRICITABINE; EN - TENOFOVIRALAFENAMIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER TENOFOVIRALAFENAMIDEFUMARAAT; REGISTRATION NO/DATE: EU/1/16/1112 20160623
0915894 08C0020 France   Get Started for $10 PRODUCT NAME: EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/07/430/001 20071213
1663240 SPC/GB15/064 United Kingdom   Get Started for $10 PRODUCT NAME: A COMBINATION OF RILPIVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT OF RILPIVIRINE, INCLUDING THE HYDROCHLORIDE SALT OF RILPIVIRINE, AND EMTRICITABINE; REGISTERED: UK EU/1/11/737/001-002 20111128
0582455 08C0021 France   Get Started for $10 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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