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

International Patents:	62
US Patents:	4
Tradenames:	3
Applicants:	14
NDAs:	14
Finished Product Suppliers / Packagers:	31
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
Wits Health Consortium (Pty) Ltd	Phase 3
London School of Hygiene and Tropical Medicine	Phase 3
Assistance Publique - Hôpitaux de Paris	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
Macleods Pharms Ltd	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203442-001	May 15, 2020	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	021752-003	Mar 10, 2016	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aurobindo Pharma Ltd	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	211640-002	Mar 9, 2023	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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gilead	TRUVADA	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021752-001	Aug 2, 2004	⤷ Sign Up	⤷ Sign Up
Gilead	TRUVADA	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021752-002	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
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
Canada	2512475	COMPOSITIONS ET METHODES DESTINEES A UNE THERAPIE DE COMBINAISON ANTIVIRALE (COMPOSITIONS AND METHODS FOR COMBINATION ANTIVIRAL THERAPY)	⤷ Sign Up
China	102670629	Compositions and methods for combination antiviral therapy	⤷ Sign Up
European Patent Office	3025718	COMPOSITIONS ET PROCÉDÉS POUR UNE THÉRAPIE ANTIVIRALE COMBINÉE (COMPOSITIONS AND METHODS FOR COMBINATION ANTIVIRAL THERAPY)	⤷ Sign Up
Croatia	P20140379	PRIPRAVCI I METODE ZA KOMBINIRANU ANTIVIRUSNU TERAPIJU (COMPOSITIONS AND METHODS FOR COMBINATION ANTIVIRAL THERAPY)	⤷ Sign Up
Denmark	1583542		⤷ 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
1663240	1690062-3	Sweden	⤷ Sign Up	PRODUCT NAME: A COMBINATION OF: RILPIVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT OF RILPIVIRINE, INCLUDING THE HYDROCHLORIDE SALT OF RILPIVIRINE; EMTRICITABINE; AND TENOFOVIR ALAFENAMIDE, OR A PHARMCEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING TENOFOVIR ALAFENAMIDE FUMARATE.; REG. NO/DATE: EU/1/16/1112 20160623
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	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
0513200	122004000015	Germany	⤷ Sign Up	PRODUCT NAME: EMTRIVA-EMTRICITABINE; REGISTRATION NO/DATE: EU/1/03/261/001-003 20031024
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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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