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.

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

Summary for EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

International Patents:	62
US Patents:	4
Tradenames:	3
Applicants:	14
NDAs:	14
Finished Product Suppliers / Packagers:	29
Clinical Trials:	179
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
DailyMed Link:	EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE at DailyMed

Recent Clinical Trials for EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

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

Sponsor	Phase
Ministry of Health, Uganda	Phase 3
Desmond Tutu HIV Foundation	Phase 3
Wits Health Consortium (Pty) Ltd	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
⤷ Sign Up	⤷ Sign Up	200MG; 300MG	TABLET; ORAL

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

Pharmacology for EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Drug Class	Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Mechanism of Action	Nucleoside Reverse Transcriptase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

J05AF	Nucleoside and nucleotide reverse transcriptase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

J05AF	Nucleoside and nucleotide reverse transcriptase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amneal Pharms Co	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	209721-001	Aug 22, 2018	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
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
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
Aurobindo Pharma	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	090513-001	Jan 26, 2018	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Amneal Pharms Co	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	209721-004	Aug 22, 2018	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ 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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gilead	TRUVADA	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021752-003	Mar 10, 2016	⤷ Sign Up	⤷ Sign Up
Gilead	TRUVADA	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021752-001	Aug 2, 2004	⤷ Sign Up	⤷ Sign Up
Gilead	TRUVADA	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021752-004	Mar 10, 2016	⤷ Sign Up	⤷ Sign Up
Gilead	TRUVADA	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021752-001	Aug 2, 2004	⤷ Sign Up	⤷ Sign Up
Gilead	TRUVADA	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021752-001	Aug 2, 2004	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

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Country	Patent Number	Title	Estimated Expiration
South Korea	20090053867	COMPOSITIONS AND METHODS FOR COMBINATION ANTIVIRAL THERAPY	⤷ Sign Up
Argentina	040805	COMPOSICIONES QUE CONTIENEN TENOFOVIR Y EMTRICITABINA Y METODOS PARA TERAPIA ANTIVIRAL	⤷ Sign Up
European Patent Office	3025718	COMPOSITIONS ET PROCÉDÉS POUR UNE THÉRAPIE ANTIVIRALE COMBINÉE (COMPOSITIONS AND METHODS FOR COMBINATION ANTIVIRAL THERAPY)	⤷ Sign Up
Norway	340951		⤷ Sign Up
South Korea	100860136		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0582455	08C0021	France	⤷ Sign Up	PRODUCT NAME: EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/07/430/001 20071213
0513200	122004000015	Germany	⤷ Sign Up	PRODUCT NAME: EMTRIVA-EMTRICITABINE; REGISTRATION NO/DATE: EU/1/03/261/001-003 20031024
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
1632232	300852	Netherlands	⤷ Sign Up	PRODUCT NAME: COMBINATIE VAN: - RILPIVIRINEHYDROCHLORIDE OF EEN THERAPEUTISCH EQUIVALENTE VORM DAARVAN ZOALS BESCHERMD DOOR HET BASISOCTROOI; - EMTRICITABINE; EN - TENOFOVIRALAFENAMIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER TENOFOVIRALAFENAMIDEFUMARAAT; REGISTRATION NO/DATE: EU/1/16/1112 20160623
1663240	15C0071	France	⤷ Sign Up	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
>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.