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atripla Drug Patent Profile

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Which patents cover Atripla, and what generic alternatives are available?

Atripla is a drug marketed by Gilead Sciences and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and twenty-three patent family members in thirty-one countries.

The generic ingredient in ATRIPLA is efavirenz; emtricitabine; tenofovir disoproxil fumarate. There are twenty-six drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the efavirenz; emtricitabine; tenofovir disoproxil fumarate profile page.

DrugPatentWatch^® Generic Entry Outlook for Atripla

Atripla was eligible for patent challenges on July 2, 2007.

There have been eighteen patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There are two tentative approvals for the generic drug (efavirenz; emtricitabine; tenofovir disoproxil fumarate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Summary for atripla

International Patents:	123
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	54
Drug Prices:	Drug price information for atripla
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for atripla
What excipients (inactive ingredients) are in atripla?	atripla excipients list
DailyMed Link:	atripla at DailyMed

Drug patent expirations by year for atripla

Recent Clinical Trials for atripla

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

Sponsor	Phase
University of Cape Town	Phase 1
Willem Daniel Francois Venter	Phase 1
Yu-Jay Corp.	Phase 3

See all atripla clinical trials

Pharmacology for atripla

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

Paragraph IV (Patent) Challenges for ATRIPLA

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 atripla

atripla is protected by ten US patents.

Patents protecting atripla

Compositions and methods for combination antiviral therapy
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER

Compositions and methods for combination antiviral therapy
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Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF HIV-1 INFECTION IN ADULTS

Unitary pharmaceutical dosage form
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Patent Expiration: ⤷ Sign Up

Compositions and methods for combination antiviral therapy
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF HIV INFECTION

Unitary pharmaceutical dosage form
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Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF HIV-1 INFECTION IN ADULTS

Unitary pharmaceutical dosage form
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER

Compositions and methods for combination antiviral therapy
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF HIV INFECTION

Unitary pharmaceutical dosage form
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER

Unitary pharmaceutical dosage form
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF HIV-1 INFECTION IN ADULTS

Compositions and methods for combination antiviral therapy
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Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF HIV INFECTION

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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		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Gilead Sciences	ATRIPLA	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021937-001	Jul 12, 2006		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Gilead Sciences	ATRIPLA	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021937-001	Jul 12, 2006		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Gilead Sciences	ATRIPLA	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021937-001	Jul 12, 2006		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Gilead Sciences	ATRIPLA	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021937-001	Jul 12, 2006		DISCN	Yes	No	⤷ 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 atripla

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

International Patents for atripla

See the table below for patents covering atripla around the world.

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Country	Patent Number	Title	Estimated Expiration
Luxembourg	91446		⤷ Sign Up
Hungary	227485	PROCESS FOR PRODUCING BCH-189 AND ITS RELATED COMPOUNDS	⤷ Sign Up
Australia	662130		⤷ Sign Up
Hong Kong	1164123	含有泰諾福韋、恩曲他濱、依法韋倫和表面活性劑的單藥物劑型 (UNITARY PHARMACEUTICAL DOSAGE FORM COMPRISING TENOFOVIR DF, EMTRICITABINE, EFAVIRENZ AND A SURFACTANT DF)	⤷ Sign Up
Portugal	100151	2-HIDROXI-METIL-5-(5-FLUOROCITOSIN-1-IL)-1,3-OXATIOLANO E SEUS DERIVADOS COM ACTIVIDADE ANTI-VIRAL E PROCESSO PARA A SUA PREPARACAO	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for atripla

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0915894	91178	Luxembourg	⤷ Sign Up	91178, EXPIRES: 20200221
0915894	C00915894/01	Switzerland	⤷ Sign Up	PRODUCT NAME: TENOFOVIR DISOPROXILFUMARAT + EMTRICITABIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57316 21.03.2006
0915894	CA 2005 00032	Denmark	⤷ Sign Up
0915894	SPC018/2008	Ireland	⤷ Sign Up	SPC018/2008: 20090811, EXPIRES: 20220724
0915894	266	Finland	⤷ Sign Up
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

Indicators of Generic Entry

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Summary for atripla

Recent Clinical Trials for atripla

Pharmacology for atripla

Paragraph IV (Patent) Challenges for ATRIPLA

Patents protecting atripla

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