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Last Updated: December 12, 2019

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Emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate - Generic Drug Details

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

Emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate is the generic ingredient in one branded drug marketed by Gilead Sciences Inc and is included in one NDA. There are twelve patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate has four hundred and fifty-six patent family members in fifty countries.

There are eighteen drug master file entries for emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate. Three suppliers are listed for this compound.

Summary for emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate

International Patents:	456
US Patents:	12
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	18
Suppliers / Packagers:	3
Clinical Trials:	10
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate
DailyMed Link:	emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate at DailyMed

Recent Clinical Trials for emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate

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Sponsor	Phase
Janssen Pharmaceutical K.K.	Phase 4
Azienda Ospedaliera San Gerardo di Monza	Phase 4
Gilead Sciences	Phase 4

See all emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate clinical trials

Recent Litigation for emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate

Identify potential future generic entrants

District Court Litigation

Case Name	Date
GILEAD SCIENCES, INC. v. ZYDUS PHARMACEUTICALS (USA) INC.	2019-01-15
GILEAD SCIENCES, INC. v. STRIDES PHARMA, INC.	2018-06-27
Gilead Sciences, Inc. v. Aurobindo Pharma Ltd.	2018-05-18

See all emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate litigation

PTAB Litigation

Petitioner	Date
Mylan Pharmaceuticals Inc.	2014-06-04

See all emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate litigation

Pharmacology for emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate

Drug Class	Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Mechanism of Action	Nucleoside Reverse Transcriptase Inhibitors Non-Nucleoside Reverse Transcriptase Inhibitors

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

Tradename	Dosage	Ingredient	NDA	Submissiondate
COMPLERA	TABLET;ORAL	emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate	202123	2015-05-20

US Patents and Regulatory Information for emtricitabine; rilpivirine hydrochloride; 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 Inc	COMPLERA	emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate	TABLET;ORAL	202123-001	Aug 10, 2011		RX	Yes	Yes	Start Trial	Start Trial	Y			Start Trial
Gilead Sciences Inc	COMPLERA	emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate	TABLET;ORAL	202123-001	Aug 10, 2011		RX	Yes	Yes	Start Trial	Start Trial	Y	Y		Start Trial
Gilead Sciences Inc	COMPLERA	emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate	TABLET;ORAL	202123-001	Aug 10, 2011		RX	Yes	Yes	Start Trial	Start Trial	Y			Start Trial
Gilead Sciences Inc	COMPLERA	emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate	TABLET;ORAL	202123-001	Aug 10, 2011		RX	Yes	Yes	Start Trial	Start Trial	Y			Start Trial
Gilead Sciences Inc	COMPLERA	emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate	TABLET;ORAL	202123-001	Aug 10, 2011		RX	Yes	Yes	Start Trial	Start Trial			Y	Start 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 emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gilead Sciences Inc	COMPLERA	emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate	TABLET;ORAL	202123-001	Aug 10, 2011	Start Trial	Start Trial
Gilead Sciences Inc	COMPLERA	emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate	TABLET;ORAL	202123-001	Aug 10, 2011	Start Trial	Start Trial
Gilead Sciences Inc	COMPLERA	emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate	TABLET;ORAL	202123-001	Aug 10, 2011	Start Trial	Start Trial
Gilead Sciences Inc	COMPLERA	emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate	TABLET;ORAL	202123-001	Aug 10, 2011	Start Trial	Start Trial
Gilead Sciences Inc	COMPLERA	emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate	TABLET;ORAL	202123-001	Aug 10, 2011	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate

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Country	Patent Number	Estimated Expiration
Croatia	P20120265	Start Trial
Lithuania	PA2016045	Start Trial
Japan	2015044839	Start Trial
Eurasian Patent Organization	200501134	Start Trial
European Patent Office	1419152	Start Trial
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1663240	300767	Netherlands	Start Trial	PRODUCT NAME: COMBINATIE VAN RILPIVIRINE OF EEN THERAPEUTISCH EQUIVALENTE VORM DAARVAN DIE BESCHERMD WORDT DOOR HET BASISOCTROOI, ZOALS EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN RILPIVIRINE, WAARONDER HET HYDROCHLORIDEZOUT VAN RILPIVIRINE, EN TENOFOVIR, IN HET BIJZONDER TENOFOVIRDISOPROXILFUMARAAT; REGISTRATION NO/DATE: EU/1/11/737/001 20111128
1419152	CA 2012 00019	Denmark	Start Trial
0513200	SZ 7/2004	Austria	Start Trial
1663240	C20150040 00167	Estonia	Start Trial	PRODUCT NAME: RILPIVIRIINI (VESINIKKLORIIDSOOLANA), TENOFOVIIR-;REG NO/DATE: EU/1/11/737/001-002 28.11.2011
1663240	2015/054	Ireland	Start Trial	PRODUCT NAME: A COMBINATION OF RILPIVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING THE HYDROCHLORIDE SALT, AND TENOFOVIR, IN PARTICULAR TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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