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ATRIPLA Drug Patent Profile

When do Atripla patents expire, 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. Eight 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

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
Formulation / Manufacturing:	see details
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

See drug prices for ATRIPLA

Recent Clinical Trials for ATRIPLA

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

Sponsor	Phase
Willem Daniel Francois Venter	Phase 1
University of Cape Town	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

Anatomical Therapeutic Chemical (ATC) Classes for ATRIPLA

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

J05AG	Non-nucleoside reverse transcriptase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

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

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			Y
Gilead Sciences	ATRIPLA	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021937-001	Jul 12, 2006	AB	RX	Yes	Yes
Gilead Sciences	ATRIPLA	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021937-001	Jul 12, 2006	AB	RX	Yes	Yes			Y
Gilead Sciences	ATRIPLA	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021937-001	Jul 12, 2006	AB	RX	Yes	Yes			Y
Gilead Sciences	ATRIPLA	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021937-001	Jul 12, 2006	AB	RX	Yes	Yes			Y
Gilead Sciences	ATRIPLA	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021937-001	Jul 12, 2006	AB	RX	Yes	Yes			Y
Gilead Sciences	ATRIPLA	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021937-001	Jul 12, 2006	AB	RX	Yes	Yes			Y

Expired US Patents for ATRIPLA

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
Gilead Sciences	ATRIPLA	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021937-001	Jul 12, 2006
Gilead Sciences	ATRIPLA	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021937-001	Jul 12, 2006
Gilead Sciences	ATRIPLA	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021937-001	Jul 12, 2006
Gilead Sciences	ATRIPLA	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021937-001	Jul 12, 2006
Gilead Sciences	ATRIPLA	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021937-001	Jul 12, 2006
Gilead Sciences	ATRIPLA	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021937-001	Jul 12, 2006

International Patents for ATRIPLA

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

Country	Patent Number	Title	Estimated Expiration
Japan	2017057233	ヌクレオチドアナログ組成物および合成方法 (NUCLEOTIDE ANALOG COMPOSITION AND SYNTHESIS METHOD)
Portugal	1067936
New Zealand	336510	Process for the crystallization of a reverse transcriptase inhibitor using an anti-solvent
New Zealand	540728	Compositions and methods for combination antiviral therapy
Japan	5557999
China	1920050
Japan	3987335

Supplementary Protection Certificates for ATRIPLA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0513200	7/2004	Austria		PRODUCT NAME: EMTRICITABIN; NAT. REGISTRATION NO/DATE: EU/1/03/261/001- EU/1/03/261/003 20031024; FIRST REGISTRATION: EU EU/1/03/261/003
0915894	CA 2008 00023	Denmark
0915894	08C0020	France		PRODUCT NAME: EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/07/430/001 20071213
0582455	SPC029/2000	Ireland		SPC029/2000: 20050912, EXPIRES: 20131119
0915894	C00915894/01	Switzerland		PRODUCT NAME: TENOFOVIR DISOPROXILFUMARAT + EMTRICITABIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57316 21.03.2006
0582455	2008/016	Ireland		PRODUCT NAME: A COMBINATION OF EFAVIRENZ AND EMTRICTABINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/07/430/001 20071213
0582455	SPC/GB00/035	United Kingdom		PRODUCT NAME: EFAVIRENZ, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: CH IKS-54 908 01 19981120; CH IKS-54 908 02 19981120; CH IKS-54 908 03 19981120; UK EU/1/99/110/001 19990528; UK EU/1/99/110/002 19990528; UK EU/1/99/110/003 19990528; UK EU/1/99/110/004 19990528; UK EU/1/99/111/001 19990528; UK EU/1/99/111/002 19990528; UK EU/1/99/111/003 19990528; UK EU/1/99/111/004 19990528