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Last Updated: September 21, 2021

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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 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 five hundred and fifteen patent family members in fifty-nine countries.

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

Summary for emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate
International Patents:515
US Patents:12
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 18
Finished Product Suppliers / Packagers: 2
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

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

SponsorPhase
Janssen Pharmaceutical K.K.Phase 4
Gilead SciencesPhase 4
Azienda Ospedaliera San Gerardo di MonzaPhase 4

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

Pharmacology for emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate
Drug ClassHuman 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 ActionNucleoside Reverse Transcriptase Inhibitors
Non-Nucleoside Reverse Transcriptase Inhibitors
Anatomical Therapeutic Chemical (ATC) Classes for emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate
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 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

Glossary
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 ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Gilead Sciences Inc COMPLERA emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate TABLET;ORAL 202123-001 Aug 10, 2011 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Gilead Sciences Inc COMPLERA emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate TABLET;ORAL 202123-001 Aug 10, 2011 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y Y ⤷  Try it Free
Gilead Sciences Inc COMPLERA emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate TABLET;ORAL 202123-001 Aug 10, 2011 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Gilead Sciences Inc COMPLERA emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate TABLET;ORAL 202123-001 Aug 10, 2011 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Expired US Patents for emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate

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

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

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1663240 132016000024751 Italy ⤷  Try it Free PRODUCT NAME: ASSOCIAZIONE DI RILPIVIRINA E OGNI SUA FORMA TERAPEUTICAMENTE EQUIVALENTE PROTETTA DAL BREVETTO DI BASE, COME SALI DI ADDIZIONE FARMACEUTICAMENTE ACCETTABILI DI RILPIVIRINA, COMPRESO IL SUO SALE CLORIDRATO E EMTRICITABINA(EVIPLERA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/11/737/001-002, 20111128
1632232 122016000111 Germany ⤷  Try it Free PRODUCT NAME: KOMBINATION VON RILPIVIRINHYDROCHLORID ODER EINER THERAPEUTISCH AEQUIVALENTEN, DURCH DAS GRUNDPATENT GESCHUETZTEN FORM DAVON, EMTRICITABIN UND TENOFOVIRALAFENAMID ODER EINEM PHARMAZEUTISCH AKZEPTABLEN SALZ DAVON, INSBESONDERE TENOFOVIRALAFENAMIDFUMARAT; REGISTRATION NO/DATE: EU/1/16/1112 20160621
1419152 C 2012 016 Romania ⤷  Try it Free PRODUCT NAME: COMBINATIE DE RILPIVIRINA SI TOATE FORMELE ECHIVALENTETERAPEUTIC ALE ACESTEIA CUM AR FI SARURILE DE ADITIE ALE RILPIVIRINEI ACCEPTABILE FARMACEUTIC, INCLUSIV SAREARILPIVIRINEI CU ACIDUL CLORHIDRIC, SI TENOFOVIR, IN PARTICULAR FUMARAT DE TENOFOVIRDISOPROXIL; NATIONAL AUTHORISATION NUMBER: EU/1/11/737/001, EU/1/11/737/002; DATE OF NATIONAL AUTHORISATION: 20111128; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/11/737/001, EU/1/11/737/002; DATE OF FIRST AUTHORISATION IN EEA: 20111128
1663240 122016000109 Germany ⤷  Try it Free PRODUCT NAME: KOMBINATION VON RILPIVIRIN ODER EINER THERAPEUTISCH AEQUIVALENTEN, DURCH DAS GRUNDPATENT GESCHUETZTEN FORM DAVON, Z.B. EINEM PHARMAZEUTISCH AKZEPTABLEN SALZ VON RILPIVIRIN, EINSCHLIESSLICH DES HYDROCHLORIDSALZES VON RILPIVIRIN. EMTRICITABIN UND TENOFOVIRALAFENAMID ODER EINEM PHARMAZEUTISCH AKZEPTABLEN SALZ DAVON, INSBESONDERE TENOFOVIRALAFENAMIDFUMARAT; REGISTRATION NO/DATE: EU/1/16/1112 20160621
1419152 2012/017 Ireland ⤷  Try it Free PRODUCT NAME: RILPIVIRINE OR A PHARMACEUTICALLY ACCEPTABLE ADDITION SALT THEREOF, INCLUDING THE HYDROCHLORIC ACID SALT OF RILPIVIRINE; REGISTRATION NO/DATE: EU/1/11/736/001 20111128
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKinsey
McKesson
AstraZeneca
Dow
Colorcon
Harvard Business School

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.

 
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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2021, www.DrugPatentWatch.com.

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