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

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What are the generic drug 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 seven 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 three hundred and thirty-four patent family members in fifty-two countries.

One supplier is listed for this compound.

Summary for emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate

International Patents:	334
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	11
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

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate

Generic Entry Date for emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up Dosage: TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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

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

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

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

Pharmacology for emtricitabine; rilpivirine hydrochloride; 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	Non-Nucleoside Reverse Transcriptase Inhibitors Nucleoside Reverse Transcriptase Inhibitors

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

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

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
COMPLERA	Tablets	emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate	200 mg/25 mg/ 300 mg	202123	1	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	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Gilead Sciences Inc	COMPLERA	emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate	TABLET;ORAL	202123-001	Aug 10, 2011		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Gilead Sciences Inc	COMPLERA	emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate	TABLET;ORAL	202123-001	Aug 10, 2011		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Gilead Sciences Inc	COMPLERA	emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate	TABLET;ORAL	202123-001	Aug 10, 2011		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	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 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	⤷ Sign Up	⤷ Sign Up
Gilead Sciences Inc	COMPLERA	emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate	TABLET;ORAL	202123-001	Aug 10, 2011	⤷ Sign Up	⤷ Sign Up
Gilead Sciences Inc	COMPLERA	emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate	TABLET;ORAL	202123-001	Aug 10, 2011	⤷ Sign Up	⤷ Sign Up
Gilead Sciences Inc	COMPLERA	emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate	TABLET;ORAL	202123-001	Aug 10, 2011	⤷ Sign Up	⤷ Sign Up
>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	Title	Estimated Expiration
Costa Rica	9031	CLORHIDRATO DE 4-((4-((4-2-CIANOETENIL)-2,6-DIMETILFENIL)AMINO)-2-PIRIMIDINIL)AMINO)BENZONITRILO	⤷ Sign Up
Poland	1632232		⤷ Sign Up
Argentina	084500	TABLETA MULTICAPA PARA TRATAR LA INFECCION POR HIV EN UN HUMANO	⤷ Sign Up
Spain	2368996		⤷ Sign Up
>Country	>Patent Number	>Title	>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
1632232	SPC/GB17/007	United Kingdom	⤷ Sign Up	PRODUCT NAME: A COMBINATION OF RILPIVIRINE HYDROCHLORIDE AND TENOFOVIR ALAFENAMIDE, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR TENOFOVIR ALAFENAMIDE FUMARATE; REGISTERED: UK EU/1/16/1112 (NI) 20160623; UK PLGB 11972/0019 20160623
1632232	PA2016042	Lithuania	⤷ Sign Up	PRODUCT NAME: RILPIVIRINO HIDROCHLORIDAS + EMTRICITABINAS + TENOFOVIRO ALAFENAMIDAS; REGISTRATION NO/DATE: EU/1/16/1112 20160621
1419152	C300532	Netherlands	⤷ Sign Up	PRODUCT NAME: EEN COMBINATIE VAN RILPIVIRINE EN ELKE DOOR HET BASISOCTROOI BESCHERMDE THERAPEUTISCH EQUIVALENTE VORM DAARVAN,; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
1663240	92854	Luxembourg	⤷ Sign Up	PRODUCT NAME: COMBINAISON DE RILPIVIRINE OU UNE FORME THERAPEUTIQUE EQUIVALENTE QUI EN DERIVE TELLE QUE PROTEGEE PAR LE BREVET DE BASE, TEL QU'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE RILPIVIRINE, INCLUANT LE SEL CHLORHYDRATE DE RILPIVIRINE, ET TENOFOVIR, EN PARTICULIER LE FUMARATE DE TENOFOVIR DISOPROXIL
>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 verification 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.