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Last Updated: October 12, 2024

COMPLERA Drug Patent Profile


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When do Complera patents expire, and what generic alternatives are available?

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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Drug patent expirations by year for COMPLERA
Drug Prices for COMPLERA

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DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for COMPLERA
Generic Entry Date for COMPLERA*:
Constraining patent/regulatory exclusivity:
NDA:
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
Gilead SciencesPhase 3
CIHR Canadian HIV Trials NetworkPhase 3
Ottawa Hospital Research InstitutePhase 3

See all COMPLERA clinical trials

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

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
>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 COMPLERA

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
Patent: THERAPEUTIC COMPOSITIONS COMPRISING RILPIVIRINE HCL AND TENOFOVIR DISOPROXIL FUMARATE
Estimated Expiration: ⤷  Sign Up

Argentina

Patent: 4500
Patent: TABLETA MULTICAPA PARA TRATAR LA INFECCION POR HIV EN UN HUMANO
Estimated Expiration: ⤷  Sign Up

Patent: 3409
Patent: COMPOSICIONES TERAPÉUTICAS
Estimated Expiration: ⤷  Sign Up

Australia

Patent: 11329642
Patent: Therapeutic compositions comprising rilpivirine HCl and tenofovir disoproxil fumarate
Estimated Expiration: ⤷  Sign Up

Patent: 16208417
Patent: Therapeutic compositions comprising rilpivirine HCl and tenofovir disoproxil fumarate
Estimated Expiration: ⤷  Sign Up

Patent: 18202635
Patent: Therapeutic compositions comprising rilpivirine HCl and tenofovir disoproxil fumarate
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 2013012245
Patent: composições terapêuticas compreendendo hcl de rilpivirina e fumarato de tenofovir disoproxila
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 18097
Patent: COMPOSITIONS THERAPEUTIQUES COMPRENANT UN HYDROCHLORURE DE RILPIVIRINE ET UN FUMARATE DE TENOFOVIR DISOPROXIL (THERAPEUTIC COMPOSITIONS COMPRISING RILPIVIRINE HCL AND TENOFOVIR DISOPROXIL FUMARATE)
Estimated Expiration: ⤷  Sign Up

Chile

Patent: 13001402
Patent: 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.
Estimated Expiration: ⤷  Sign Up

China

Patent: 3491948
Patent: Therapeutic compositions comprising rilpivirine hcl and tenofovir disoproxil fumarate
Estimated Expiration: ⤷  Sign Up

Patent: 6511357
Patent: 包含利匹韦林HCl和富马酸替诺福韦酯的治疗组合物 (Therapeutic compositions comprising rilpivirine HCL and tenofovir disoproxil fumarate)
Estimated Expiration: ⤷  Sign Up

Colombia

Patent: 61300
Patent: Composiciones terapéuticas que comprenden rilvipirina hcl y tenofovir disoproxil fumarato
Estimated Expiration: ⤷  Sign Up

Costa Rica

Patent: 130293
Patent: COMPOSICIONES TERAPÉUTICAS QUE COMPRENDEN RILPIVIRINA HCL Y TENOFOVIR DISOPROXIL FUMARATO
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
Patent: COMPOSICIONES TERAPÉUTICAS QUE COMPRENDEN RILPIVIRINA HCL Y TENOFOVIR DISOPROXIL FUMARATO
Estimated Expiration: ⤷  Sign Up

Patent: 19078196
Patent: COMPOSICIONES TERAPÉUTICAS QUE COMPRENDEN RILPIVIRINA HCL Y TENOFOVIR DISOPROXIL FUMARATO
Estimated Expiration: ⤷  Sign Up

Eurasian Patent Organization

Patent: 5852
Patent: ТЕРАПЕВТИЧЕСКИЕ КОМПОЗИЦИИ, СОДЕРЖАЩИЕ РИЛПИВИРИН HCl И ТЕНОФОВИРА ДИЗОПРОКСИЛФУМАРАТ (THERAPEUTIC COMPOSITIONS COMPRISING RILPIVIRINE HCl AND TENOFOVIR DISOPROXIL FUMARATE)
Estimated Expiration: ⤷  Sign Up

Patent: 1390651
Patent: ТЕРАПЕВТИЧЕСКИЕ КОМПОЗИЦИИ, СОДЕРЖАЩИЕ РИЛПИВИРИН HCL И ТЕНОФОВИРА ДИЗОПРОКСИЛФУМАРАТ
Estimated Expiration: ⤷  Sign Up

Patent: 1691695
Patent: ТЕРАПЕВТИЧЕСКИЕ КОМПОЗИЦИИ, СОДЕРЖАЩИЕ РИЛПИВИРИН HCL И ТЕНОФОВИРА ДИЗОПРОКСИЛФУМАРАТ
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 40362
Patent: COMPOSITIONS THÉRAPEUTIQUES COMPRENANT UN HYDROCHLORURE DE LA RILPIVIRINE ET UN FUMARATE DE TÉNOFOVIR DISOPROXIL (THERAPEUTIC COMPOSITIONS COMPRISING RILPIVIRIN HCL AND TENOVOFIR DISOPROXIL FUMARATE)
Estimated Expiration: ⤷  Sign Up

Patent: 26466
Patent: Compositions thérapeutiques comprenant du rilpivirin hcl et du ténofovir disoproxil fumarate (Therapeutic compositions comprising rilpivirin hcl and tenofovir disoproxil fumarate)
Estimated Expiration: ⤷  Sign Up

Hong Kong

Patent: 90064
Patent: 含有鹽酸利匹韋林和富馬酸替諾福韋酯的治療組合物 (THERAPEUTIC COMPOSITIONS COMPRISING RILPIVIRIN HCL AND TENOVOFIR DISOPROXIL FUMARATE)
Estimated Expiration: ⤷  Sign Up

Patent: 06592
Patent: 含有鹽酸利匹韋林和富馬酸替諾福韋酯的治療組合物 (THERAPEUTIC COMPOSITIONS COMPRISING RILPIVIRIN HCL AND TENOFOVIR DISOPROXIL FUMARATE)
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 6300
Patent: תכשירים טיפוליים המכילים רילפיבירין הידרוכלוריד ודנופוביר דיסאופרוקסיל פומאראט (Therapeutic compositions comprising rilpivirine hcl and tenofovir disoproxil fumarate)
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 38851
Estimated Expiration: ⤷  Sign Up

Patent: 14500261
Estimated Expiration: ⤷  Sign Up

Patent: 15131853
Patent: リルピビリンHClおよびフマル酸テノホビルジソプロキシルを含有する治療用組成物 (THERAPEUTIC COMPOSITIONS COMPRISING RILPIVIRINE HCl AND TENOFOVIR DISOPROXIL FUMARATE)
Estimated Expiration: ⤷  Sign Up

Malaysia

Patent: 5604
Patent: THERAPEUTIC COMPOSITIONS COMPRISING RILPIVIRINE HCL AND TENOFOVIR DISOPROXIL FUMARATE
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 7512
Patent: COMPOSICIONES TERAPEUTICAS QUE COMPRENDEN HCL DE RILPIVIRINA Y FUMARATO DE DISOPROXILO DE TENOFOVIR. (THERAPEUTIC COMPOSITIONS COMPRISING RILPIVIRINE HCL AND TENOFOVIR DISOPROXIL FUMARATE.)
Estimated Expiration: ⤷  Sign Up

Patent: 13005669
Patent: COMPOSICIONES TERAPEUTICAS QUE COMPRENDEN HCL DE RILPIVIRINA Y FUMARATO DE DISOPROXILO DE TENOFOVIR. (THERAPEUTIC COMPOSITIONS COMPRISING RILPIVIRINE HCL AND TENOFOVIR DISOPROXIL FUMARATE.)
Estimated Expiration: ⤷  Sign Up

Montenegro

Patent: 980
Patent: TERAPEUTSKE KOMPOZICIJE KOJE SADRŽE RILPIVIRIN HCL I TENOFOVIR DIZOPROKSIL FUMARAT (THERAPEUTIC COMPOSITIONS COMPRISING RILPIVIRINE HCL AND TENOFOVIR DISOPROXIL FUMARATE)
Estimated Expiration: ⤷  Sign Up

Morocco

Patent: 735
Patent: COMPOSITIONS THÉRAPEUTIQUES COMPRENANT UN HYDROCHLORURE DE RILPIVIRINE ET UN FUMARATE DE TÉNOFOVIR DISOPROXIL
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 0729
Patent: Therapeutic compositions comprising rilpivirine hcl and tenofovir disoproxil fumarate
Estimated Expiration: ⤷  Sign Up

Peru

Patent: 140163
Patent: COMPOSICIONES TERAPEUTICAS QUE COMPRENDEN RILPIVIRINA HCL Y TENOFOVIR DISOPROXIL FUMARATO
Estimated Expiration: ⤷  Sign Up

Patent: 170521
Patent: COMBINACION FARMACEUTICA QUE COMPRENDE RILPIVIRINA HCL, TENOFOVIR DISOPROXIL FUMARATO Y EMTRICITABINA
Estimated Expiration: ⤷  Sign Up

Patent: 211657
Patent: COMPOSICIONES TERAPEUTICAS QUE COMPRENDEN RILPIVIRINA HCL Y TENOFOVIR DISOPROXIL FUMARATO
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 40362
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 40362
Estimated Expiration: ⤷  Sign Up

San Marino

Patent: 01400150
Patent: Composizioni terapeutiche comprendenti rilpivirinacloridrato e tenofovir disoproxil fumarato
Estimated Expiration: ⤷  Sign Up

Serbia

Patent: 691
Patent: TERAPEUTSKE KOMPOZICIJE KOJE SADRŽE RILPIVIRIN HCL I TENOVOFIR DIZOPROKSIL FUMARAT (THERAPEUTIC COMPOSITIONS COMPRISING RILPIVIRIN HCL AND TENOVOFIR DISOPROXIL FUMARATE)
Estimated Expiration: ⤷  Sign Up

Singapore

Patent: 0333
Patent: THERAPEUTIC COMPOSITIONS COMPRISING RILPIVIRINE HCL AND TENOFOVIR DISOPROXIL FUMARATE
Estimated Expiration: ⤷  Sign Up

Patent: 201509521W
Patent: THERAPEUTIC COMPOSITIONS COMPRISING RILPIVIRINE HCL AND TENOFOVIR DISOPROXIL FUMARATE
Estimated Expiration: ⤷  Sign Up

Patent: 201912527X
Patent: THERAPEUTIC COMPOSITIONS COMPRISING RILPIVIRINE HCL AND TENOFOVIR DISOPROXIL FUMARATE
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 40362
Estimated Expiration: ⤷  Sign Up

South Africa

Patent: 1304481
Patent: THERAPEUTIC COMPOSITIONS COMPRISING RILPIVIRINE HCL AND TENOFOVIR DISOPROXIL FUMARATE
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 1923103
Estimated Expiration: ⤷  Sign Up

Patent: 140037799
Patent: THERAPEUTIC COMPOSITIONS COMPRISING RILPIVIRINE HCL AND TENOFOVIR DISOPROXIL FUMARATE
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 24408
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 56840
Estimated Expiration: ⤷  Sign Up

Patent: 1238612
Patent: Therapeutic compositions
Estimated Expiration: ⤷  Sign Up

Ukraine

Patent: 4075
Patent: БАГАТОШАРОВА ТАБЛЕТКА, ЩО МІСТИТЬ РИЛПІВІРИН HCl, ЕМТРИЦИТАБІН І ТЕНОФОВІРУ ДИЗОПРОКСИЛФУМАРАТ
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
Cyprus 1116115 ⤷  Sign Up
Cyprus 1112249 ⤷  Sign Up
Croatia P20150798 ⤷  Sign Up
Poland 171150 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for COMPLERA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1419152 C01419152/01 Switzerland ⤷  Sign Up PRODUCT NAME: RILPIVIRIN; REGISTRATION NO/DATE: SWISSMEDIC 61548 26.02.2013
1663240 300767 Netherlands ⤷  Sign Up DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGE OF OWNER(S) NAME
0915894 08C0020 France ⤷  Sign Up PRODUCT NAME: EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/07/430/001 20071213
1419152 PA2012008 Lithuania ⤷  Sign Up PRODUCT NAME: RILPIVIRINUM; REGISTRATION NO/DATE: EU/1/11/736/001 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 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.