You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 19, 2024

COMPLERA Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


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

< Available with Subscription >

  Try a Trial

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*:
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
CIHR Canadian HIV Trials NetworkPhase 3
Ottawa Hospital Research InstitutePhase 3
Gilead SciencesPhase 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 ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

HIV inhibiting pyrimidines derivatives
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF HIV INFECTION

Compositions and methods for combination antiviral therapy
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF HIV INFECTION

Compositions and methods for combination antiviral therapy
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF HIV INFECTION

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

Compositions and methods for combination antiviral therapy
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF HIV INFECTION

Compositions and methods for combination antiviral therapy
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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 ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Gilead Sciences Inc COMPLERA emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate TABLET;ORAL 202123-001 Aug 10, 2011 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Gilead Sciences Inc COMPLERA emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate TABLET;ORAL 202123-001 Aug 10, 2011 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a 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 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
Estimated Expiration: ⤷  Try a Trial

Argentina

Patent: 4500
Estimated Expiration: ⤷  Try a Trial

Patent: 3409
Estimated Expiration: ⤷  Try a Trial

Australia

Patent: 11329642
Estimated Expiration: ⤷  Try a Trial

Patent: 16208417
Estimated Expiration: ⤷  Try a Trial

Patent: 18202635
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 2013012245
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 18097
Estimated Expiration: ⤷  Try a Trial

Chile

Patent: 13001402
Estimated Expiration: ⤷  Try a Trial

China

Patent: 3491948
Estimated Expiration: ⤷  Try a Trial

Patent: 6511357
Estimated Expiration: ⤷  Try a Trial

Colombia

Patent: 61300
Estimated Expiration: ⤷  Try a Trial

Costa Rica

Patent: 130293
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0140946
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 16115
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 40362
Estimated Expiration: ⤷  Try a Trial

Ecuador

Patent: 13012700
Estimated Expiration: ⤷  Try a Trial

Patent: 19078196
Estimated Expiration: ⤷  Try a Trial

Eurasian Patent Organization

Patent: 5852
Estimated Expiration: ⤷  Try a Trial

Patent: 1390651
Estimated Expiration: ⤷  Try a Trial

Patent: 1691695
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 40362
Estimated Expiration: ⤷  Try a Trial

Patent: 26466
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 90064
Estimated Expiration: ⤷  Try a Trial

Patent: 06592
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 6300
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 38851
Estimated Expiration: ⤷  Try a Trial

Patent: 14500261
Estimated Expiration: ⤷  Try a Trial

Patent: 15131853
Estimated Expiration: ⤷  Try a Trial

Malaysia

Patent: 5604
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 7512
Estimated Expiration: ⤷  Try a Trial

Patent: 13005669
Estimated Expiration: ⤷  Try a Trial

Montenegro

Patent: 980
Estimated Expiration: ⤷  Try a Trial

Morocco

Patent: 735
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 0729
Estimated Expiration: ⤷  Try a Trial

Peru

Patent: 140163
Estimated Expiration: ⤷  Try a Trial

Patent: 170521
Estimated Expiration: ⤷  Try a Trial

Patent: 211657
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 40362
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 40362
Estimated Expiration: ⤷  Try a Trial

San Marino

Patent: 01400150
Estimated Expiration: ⤷  Try a Trial

Serbia

Patent: 691
Estimated Expiration: ⤷  Try a Trial

Singapore

Patent: 0333
Estimated Expiration: ⤷  Try a Trial

Patent: 201509521W
Estimated Expiration: ⤷  Try a Trial

Patent: 201912527X
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 40362
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 1304481
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1923103
Estimated Expiration: ⤷  Try a Trial

Patent: 140037799
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 24408
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 56840
Estimated Expiration: ⤷  Try a Trial

Patent: 1238612
Estimated Expiration: ⤷  Try a Trial

Ukraine

Patent: 4075
Estimated Expiration: ⤷  Try a Trial

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
Argentina 102104 COMBINACIONES DE UNA PIRIMIDINA QUE CONTIENEN NNRTI CON INHIBIDORES DE LA RT ⤷  Try a Trial
Spain 2384715 ⤷  Try a Trial
China 1554350 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for COMPLERA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1663240 300767 Netherlands ⤷  Try a Trial DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGE OF OWNER(S) NAME
1632232 93384 Luxembourg ⤷  Try a Trial PRODUCT NAME: COMBINAISON DE CHLORHYDRATE DE RILPIVIRINE OU UNE FORME THERAPEUTIQUE EQUIVALENTE QUI EN DERIVE TELLE QUE PROTEGEE PAR LE BREVET DE BASE, 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
1663240 C 2015 038 Romania ⤷  Try a Trial PRODUCT NAME: COMBINATIE DE RILPIVIRINA SAU O FORMA TERAPEUTIC ECHIVALENTA A ACESTEIA, CUM AR FI O SARE DE RILPIVIRINA ACCEPTABILA FARMACEUTIC, INCLUSIV CLORHIDRATUL DE RILPIVIRINA SI EMTRICITABINA; NATIONAL AUTHORISATION NUMBER: EU/1/11/737/001-002; DATE OF NATIONAL AUTHORISATION: 20111128; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/11/737/001-002; DATE OF FIRST AUTHORISATION IN EEA: 20111128
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

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.