Remove trial restrictions ▶ Start for $1

Serving leading biopharmaceutical companies globally:

Express Scripts
Mallinckrodt
McKinsey
Moodys
Colorcon
AstraZeneca

Last Updated: August 10, 2022

complera Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions


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 nine patents protecting this drug and one Paragraph IV challenge.

This drug has three hundred and fifteen patent family members in forty-nine 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 sixteen 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 >

  Sign up for a Free Trial

Drug patent expirations by year for complera
Drug Prices for complera

See drug prices for complera

DrugPatentWatch® Estimated Generic Entry Opportunity 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 nine US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of complera is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

HIV inhibiting pyrimidines derivatives
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HIV INFECTION

HIV inhibiting pyrimidines derivatives
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Salt of 4-[[4-[[4-(2-cyanoethenyl)-2,6-dimethylphenyl]amino]-2-pyrimidinyl- ]amino]benzonitrile
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Compositions and methods for combination antiviral therapy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HIV INFECTION

Compositions and methods for combination antiviral therapy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HIV INFECTION

Combinations of a pyrimidine containing NNRTI with RT inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HIV INFECTION

Compositions and methods for combination antiviral therapy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HIV INFECTION

Compositions and methods for combination antiviral therapy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Gilead Sciences Inc COMPLERA emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate TABLET;ORAL 202123-001 Aug 10, 2011 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Gilead Sciences Inc COMPLERA emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate TABLET;ORAL 202123-001 Aug 10, 2011 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
>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: See Plans and Pricing

Argentina

Patent: 4500
Estimated Expiration: See Plans and Pricing

Australia

Patent: 11329642
Estimated Expiration: See Plans and Pricing

Patent: 16208417
Estimated Expiration: See Plans and Pricing

Patent: 18202635
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2013012245
Estimated Expiration: See Plans and Pricing

Canada

Patent: 18097
Estimated Expiration: See Plans and Pricing

Chile

Patent: 13001402
Estimated Expiration: See Plans and Pricing

China

Patent: 3491948
Estimated Expiration: See Plans and Pricing

Patent: 6511357
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 61300
Estimated Expiration: See Plans and Pricing

Costa Rica

Patent: 130293
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0140946
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 16115
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 40362
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 13012700
Estimated Expiration: See Plans and Pricing

Patent: 19078196
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 5852
Estimated Expiration: See Plans and Pricing

Patent: 1390651
Estimated Expiration: See Plans and Pricing

Patent: 1691695
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 40362
Estimated Expiration: See Plans and Pricing

Patent: 26466
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 90064
Estimated Expiration: See Plans and Pricing

Patent: 06592
Estimated Expiration: See Plans and Pricing

Israel

Patent: 6300
Estimated Expiration: See Plans and Pricing

Japan

Patent: 38851
Estimated Expiration: See Plans and Pricing

Patent: 14500261
Estimated Expiration: See Plans and Pricing

Patent: 15131853
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 7512
Estimated Expiration: See Plans and Pricing

Patent: 13005669
Estimated Expiration: See Plans and Pricing

Montenegro

Patent: 980
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 735
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 0729
Estimated Expiration: See Plans and Pricing

Peru

Patent: 140163
Estimated Expiration: See Plans and Pricing

Patent: 170521
Estimated Expiration: See Plans and Pricing

Patent: 211657
Estimated Expiration: See Plans and Pricing

Poland

Patent: 40362
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 40362
Estimated Expiration: See Plans and Pricing

San Marino

Patent: 01400150
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 691
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 0333
Estimated Expiration: See Plans and Pricing

Patent: 201509521W
Estimated Expiration: See Plans and Pricing

Patent: 201912527X
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 40362
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1304481
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1923103
Estimated Expiration: See Plans and Pricing

Patent: 140037799
Estimated Expiration: See Plans and Pricing

Spain

Patent: 24408
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 56840
Estimated Expiration: See Plans and Pricing

Patent: 1238612
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 4075
Estimated Expiration: See Plans and Pricing

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
Brazil PI0514871 cloridrato de 4-[[4-[[4-(2-cianoetenil)-2,6-dimetilfenil]amino]-2-pirimidi nil]amino] benzonitrila See Plans and Pricing
Cyprus 1116565 See Plans and Pricing
European Patent Office 0574487 UTILISATION DE 5-FLUORO-2'-DESOXY-3'-THIACYTIDINE POUR LE TRAITEMENT DE L'HEPATITE B (USE OF 5-FLUORO-2'-DEOXY-3'-THIACYTIDINE FOR THE TREATMENT OF HEPATITIS B) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for complera

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0915894 C00915894/01 Switzerland See Plans and Pricing PRODUCT NAME: TENOFOVIR DISOPROXILFUMARAT + EMTRICITABIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57316 21.03.2006
1419152 C300532 Netherlands See Plans and Pricing 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
1419152 PA2012009 Lithuania See Plans and Pricing PRODUCT NAME: EMTRICITABINUM + RILPIVIRINUM + TENOFOVIRUM DISOPROXILUM; REGISTRATION NO/DATE: EU/1/11/737/001, 2011 11 28 EU/1/11/737/002 20111128
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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

Serving leading biopharmaceutical companies globally:

Harvard Business School
McKesson
Merck
Colorcon
Johnson and Johnson
McKinsey

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.