EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE - Generic Drug Details

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:	176
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
Assistance Publique - Hôpitaux de Paris, FRANCE	Phase 3
Ministry of Health, Thailand	Phase 3
Chiang Mai University, Thailand	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
		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

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
Gilead	TRUVADA	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021752-002	Mar 10, 2016	AB	RX	Yes	No
Zydus Pharms	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	212689-002	Jul 1, 2021	AB	RX	No	No
Laurus	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	212114-001	Jul 26, 2019	AB	RX	No	No
Amneal Pharms Co	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	209721-004	Aug 22, 2018	AB	RX	No	No

Expired US Patents for EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gilead	TRUVADA	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021752-004	Mar 10, 2016
Gilead	TRUVADA	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021752-004	Mar 10, 2016
Gilead	TRUVADA	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021752-003	Mar 10, 2016
Gilead	TRUVADA	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021752-002	Mar 10, 2016

International Patents for EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Country	Patent Number	Title	Estimated Expiration
Japan	2017057232	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)
Germany	602004014470
China	105596356	Compositions and methods for combination antiviral therapy
Canada	2512319	COMPOSITIONS ET METHODES DE POLYTHERAPIE ANTIVIRALE (COMPOSITIONS AND METHODS FOR COMBINATION ANTIVIRAL THERAPY)

Supplementary Protection Certificates for EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3808743	CA 2022 00035	Denmark		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
1663240	1590057-4	Sweden		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	15C0071	France		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
0915894	08C0020	France		PRODUCT NAME: EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/07/430/001 20071213