Efavirenz; emtricitabine; tenofovir disoproxil fumarate - Generic Drug Details

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

Efavirenz; emtricitabine; tenofovir disoproxil fumarate is the generic ingredient in two branded drugs marketed by Gilead Sciences, Aurobindo Pharma, Cipla, Hetero Labs Ltd V, Laurus, Macleods Pharms Ltd, and Teva Pharms Usa, and is included in seven NDAs. There are seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Efavirenz; emtricitabine; tenofovir disoproxil fumarate has one hundred and twenty-three patent family members in thirty-one countries.

Nine suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for efavirenz; emtricitabine; tenofovir disoproxil fumarate

International Patents:	123
US Patents:	7
Tradenames:	2
Applicants:	7
NDAs:	7
Finished Product Suppliers / Packagers:	9
Clinical Trials:	39
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for efavirenz; emtricitabine; tenofovir disoproxil fumarate
DailyMed Link:	efavirenz; emtricitabine; tenofovir disoproxil fumarate at DailyMed

Recent Clinical Trials for efavirenz; emtricitabine; tenofovir disoproxil fumarate

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

Sponsor	Phase
Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida	N/A
Yu-Jay Corp.	Phase 3
University of Alberta	Phase 4

See all efavirenz; emtricitabine; tenofovir disoproxil fumarate clinical trials

Generic filers with tentative approvals for EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Applicant	Application No.	Strength	Dosage Form
⤷ Try a Trial	⤷ Try a Trial	600MG; 200MG; 300MG	TABLET; ORAL
⤷ Try a Trial	⤷ Try a Trial	200MG	TABLET; ORAL
⤷ Try a Trial	⤷ Try a Trial	600MG	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 efavirenz; emtricitabine; tenofovir disoproxil fumarate

Drug Class	Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Mechanism of Action	Cytochrome P450 2B6 Inducers Cytochrome P450 2C19 Inhibitors Cytochrome P450 2C9 Inhibitors Cytochrome P450 3A Inducers Cytochrome P450 3A4 Inhibitors Non-Nucleoside Reverse Transcriptase Inhibitors Nucleoside Reverse Transcriptase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for efavirenz; emtricitabine; tenofovir disoproxil fumarate

Paragraph IV (Patent) Challenges for EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ATRIPLA	Tablets	efavirenz; emtricitabine; tenofovir disoproxil fumarate	600 mg/200 mg/300 mg	021937	1	2008-12-29

US Patents and Regulatory Information for efavirenz; 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
Gilead Sciences	ATRIPLA	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021937-001	Jul 12, 2006	AB	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Gilead Sciences	ATRIPLA	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021937-001	Jul 12, 2006	AB	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Cipla	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	206894-001	Jun 3, 2019	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Macleods Pharms Ltd	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	204287-001	Sep 13, 2021	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Gilead Sciences	ATRIPLA	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021937-001	Jul 12, 2006	AB	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Aurobindo Pharma	EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203041-001	Sep 4, 2018	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>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 efavirenz; emtricitabine; tenofovir disoproxil fumarate

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gilead Sciences	ATRIPLA	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021937-001	Jul 12, 2006	⤷ Try a Trial	⤷ Try a Trial
Gilead Sciences	ATRIPLA	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021937-001	Jul 12, 2006	⤷ Try a Trial	⤷ Try a Trial
Gilead Sciences	ATRIPLA	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021937-001	Jul 12, 2006	⤷ Try a Trial	⤷ Try a Trial
Gilead Sciences	ATRIPLA	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021937-001	Jul 12, 2006	⤷ Try a Trial	⤷ Try a Trial
Gilead Sciences	ATRIPLA	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021937-001	Jul 12, 2006	⤷ Try a Trial	⤷ Try a Trial
Gilead Sciences	ATRIPLA	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021937-001	Jul 12, 2006	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for efavirenz; emtricitabine; tenofovir disoproxil fumarate

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Country	Patent Number	Title	Estimated Expiration
Portugal	2386294		⤷ Try a Trial
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)	⤷ Try a Trial
Australia	2009200414	Compositions and methods for combination antiviral therapy	⤷ Try a Trial
Poland	378368	Kompozycje i sposoby wykorzystywane w skojarzonej terapii przeciwwirusowej (COMPOSITIONS AND METHODS FOR COMBINATION ANTIVIRAL THERAPY)	⤷ Try a Trial
Taiwan	200716206	Unitary pharmaceutical dosage form	⤷ Try a Trial
Japan	2010120957	COMPOSITION AND METHOD FOR COMBINATION ANTIVIRAL THERAPY	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for efavirenz; emtricitabine; tenofovir disoproxil fumarate

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0582455	2001C/001	Belgium	⤷ Try a Trial	PRODUCT NAME: EFAVIRENZ; NATL. REGISTRATION NO/DATE: EU/1/99/110/001 19990604; FIRST REGISTRATION: CH 54908 01 19981120
0915894	SPC/GB08/033	United Kingdom	⤷ Try a Trial	PRODUCT NAME: TENOFOVIR DISOPROXIL AND THE SALTS (IN PARTICULAR THE FUMARATE), HYDRATES, TAUTOMERS AND SOLVATES THEREOF, TOGETHER WITH EMTRICITABINE AND EFAVIRENZ; REGISTERED: UK EU/1/07/430/001 20071213; REASON FOR LAPSE: SURRENDERED
0582455	C300032	Netherlands	⤷ Try a Trial	PRODUCT NAME: EFAVIRENZ; REGISTRATION NO/DATE: EU/1/99/110/001-004, EU/1/99/111/001-004 19990528
0915894	08C0020	France	⤷ Try a Trial	PRODUCT NAME: EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/07/430/001 20071213
0582455	08C0021	France	⤷ Try a Trial	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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