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Last Updated: May 24, 2024

COMPLERA Drug Patent Profile


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When do Complera patents expire, and when can generic versions of Complera launch?

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

This drug has three hundred and thirty-four patent family members in fifty-two countries.

The generic ingredient in COMPLERA is emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate. There are eighteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate profile page.

DrugPatentWatch® Generic Entry Outlook for Complera

Complera was eligible for patent challenges on May 20, 2015.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 14, 2033. This may change due to patent challenges or generic licensing.

There have been seventeen 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.

Indicators of Generic Entry

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Summary for COMPLERA
International Patents:334
US Patents:7
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 2
Clinical Trials: 6
Patent Applications: 119
Formulation / Manufacturing:see details
Drug Prices: Drug price information for COMPLERA
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for COMPLERA
What excipients (inactive ingredients) are in COMPLERA?COMPLERA excipients list
DailyMed Link:COMPLERA at DailyMed
Drug patent expirations by year for COMPLERA
Drug Prices for COMPLERA

See drug prices for COMPLERA

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for COMPLERA
Generic Entry Date for COMPLERA*:
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Constraining patent/regulatory exclusivity:
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NDA:
202123
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 COMPLERA

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

SponsorPhase
CIHR Canadian HIV Trials NetworkPhase 3
Ottawa Hospital Research InstitutePhase 3
Gilead SciencesPhase 3

See all COMPLERA clinical trials

Pharmacology for COMPLERA
Drug ClassHepatitis 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 ActionNon-Nucleoside Reverse Transcriptase Inhibitors
Nucleoside Reverse Transcriptase Inhibitors
Anatomical Therapeutic Chemical (ATC) Classes for COMPLERA
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 COMPLERA
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 COMPLERA

COMPLERA is protected by seven US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of COMPLERA is ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting COMPLERA

Therapeutic compositions comprising rilpivirine HCL and tenofovir disoproxil fumarate
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

HIV inhibiting pyrimidines derivatives
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF HIV INFECTION

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

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

Combinations of a pyrimidine containing NNRTI with RT inhibitors
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF HIV INFECTION

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

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

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 ⤷  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 ⤷  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
>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 COMPLERA

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
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

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International Patents for COMPLERA

When does loss-of-exclusivity occur for COMPLERA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

African Regional IP Organization (ARIPO)

Patent: 16
Estimated Expiration: ⤷  Sign Up

Argentina

Patent: 4500
Estimated Expiration: ⤷  Sign Up

Patent: 3409
Estimated Expiration: ⤷  Sign Up

Australia

Patent: 11329642
Estimated Expiration: ⤷  Sign Up

Patent: 16208417
Estimated Expiration: ⤷  Sign Up

Patent: 18202635
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 2013012245
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 18097
Estimated Expiration: ⤷  Sign Up

Chile

Patent: 13001402
Estimated Expiration: ⤷  Sign Up

China

Patent: 3491948
Estimated Expiration: ⤷  Sign Up

Patent: 6511357
Estimated Expiration: ⤷  Sign Up

Colombia

Patent: 61300
Estimated Expiration: ⤷  Sign Up

Costa Rica

Patent: 130293
Estimated Expiration: ⤷  Sign Up

Croatia

Patent: 0140946
Estimated Expiration: ⤷  Sign Up

Cyprus

Patent: 16115
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 40362
Estimated Expiration: ⤷  Sign Up

Ecuador

Patent: 13012700
Estimated Expiration: ⤷  Sign Up

Patent: 19078196
Estimated Expiration: ⤷  Sign Up

Eurasian Patent Organization

Patent: 5852
Estimated Expiration: ⤷  Sign Up

Patent: 1390651
Estimated Expiration: ⤷  Sign Up

Patent: 1691695
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 40362
Estimated Expiration: ⤷  Sign Up

Patent: 26466
Estimated Expiration: ⤷  Sign Up

Hong Kong

Patent: 90064
Estimated Expiration: ⤷  Sign Up

Patent: 06592
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 6300
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 38851
Estimated Expiration: ⤷  Sign Up

Patent: 14500261
Estimated Expiration: ⤷  Sign Up

Patent: 15131853
Estimated Expiration: ⤷  Sign Up

Malaysia

Patent: 5604
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 7512
Estimated Expiration: ⤷  Sign Up

Patent: 13005669
Estimated Expiration: ⤷  Sign Up

Montenegro

Patent: 980
Estimated Expiration: ⤷  Sign Up

Morocco

Patent: 735
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 0729
Estimated Expiration: ⤷  Sign Up

Peru

Patent: 140163
Estimated Expiration: ⤷  Sign Up

Patent: 170521
Estimated Expiration: ⤷  Sign Up

Patent: 211657
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 40362
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 40362
Estimated Expiration: ⤷  Sign Up

San Marino

Patent: 01400150
Estimated Expiration: ⤷  Sign Up

Serbia

Patent: 691
Estimated Expiration: ⤷  Sign Up

Singapore

Patent: 0333
Estimated Expiration: ⤷  Sign Up

Patent: 201509521W
Estimated Expiration: ⤷  Sign Up

Patent: 201912527X
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 40362
Estimated Expiration: ⤷  Sign Up

South Africa

Patent: 1304481
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 1923103
Estimated Expiration: ⤷  Sign Up

Patent: 140037799
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 24408
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 56840
Estimated Expiration: ⤷  Sign Up

Patent: 1238612
Estimated Expiration: ⤷  Sign Up

Ukraine

Patent: 4075
Estimated Expiration: ⤷  Sign Up

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering COMPLERA around the world.

Country Patent Number Title Estimated Expiration
African Regional IP Organization (ARIPO) 2487 Fumarate of 4-[[4-[[4-(2-cyanoethenyl)-2,6-dimethylphenyl]-amino]-2-pyrimidinyl]amino]benzonitrile ⤷  Sign Up
Chile 2013001402 Un comprimido que comprende a) una primera capa comprendiendo rilpivirina hcl, sustancialmente exenta de fumarato de diisopropilo de tenofovir, b) una segunda capa comprendiendo fumarato de diisopropilo de tenofovir, sustancialmente exenta de rilpivirina hcl, y c) adicionalmente emtricitabina; y su uso para tratar una infeccion por vih. ⤷  Sign Up
Spain 2236389 ⤷  Sign Up
Hungary T64844 ⤷  Sign Up
South Korea 20060038452 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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Supplementary Protection Certificates for COMPLERA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1419152 PA2012008,C1419152 Lithuania ⤷  Sign Up PRODUCT NAME: RILPIVIRINUM; REGISTRATION NO/DATE: EU/1/11/736/001 20111128
1419152 CA 2012 00021 Denmark ⤷  Sign Up
1663240 122016000109 Germany ⤷  Sign Up 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
0915894 CA 2008 00023 Denmark ⤷  Sign Up
1632232 93385 Luxembourg ⤷  Sign Up PRODUCT NAME: COMBINAISON DE CHLORHYDRATE DE RILPIVIRINE OU UNE FORME THERAPEUTIQUE EQUIVALENTE QUI EN DERIVE TELLE QUE PROTEGEE PAR LE BREVET DE BASE, EMTRICITABINE, ET TENOFOVIR ALAFENAMIDE, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, EN PARTICULIER LE FUMARATE DE TENOFOVIR ALAFENAMIDE; AUTHORISATION NUMBER AND DATE: EU/1/16/1112 ODEFSEY - EMTRICITABINE
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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