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Last Updated: November 28, 2021

DrugPatentWatch Database Preview

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 twelve patents protecting this drug and one Paragraph IV challenge.

This drug has five hundred and sixteen patent family members in fifty-nine countries.

The generic ingredient in COMPLERA is emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate. There are eighteen drug master file entries for this compound. Two suppliers are 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 fifteen 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 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
Ottawa Hospital Research InstitutePhase 3
Gilead SciencesPhase 3
CIHR Canadian HIV Trials NetworkPhase 3

See all COMPLERA clinical trials

Paragraph IV (Patent) Challenges for COMPLERA
Tradename Dosage Ingredient NDA Submissiondate
COMPLERA TABLET;ORAL emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate 202123 2015-05-20

US Patents and Regulatory Information for COMPLERA

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 ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Gilead Sciences Inc COMPLERA emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate TABLET;ORAL 202123-001 Aug 10, 2011 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y Y ⤷  Free Forever Trial
Gilead Sciences Inc COMPLERA emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate TABLET;ORAL 202123-001 Aug 10, 2011 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Gilead Sciences Inc COMPLERA emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate TABLET;ORAL 202123-001 Aug 10, 2011 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Gilead Sciences Inc COMPLERA emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate TABLET;ORAL 202123-001 Aug 10, 2011 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Gilead Sciences Inc COMPLERA emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate TABLET;ORAL 202123-001 Aug 10, 2011 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Gilead Sciences Inc COMPLERA emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate TABLET;ORAL 202123-001 Aug 10, 2011 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever 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

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

Supplementary Protection Certificates for COMPLERA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0915894 SPC/GB05/041 United Kingdom ⤷  Free Forever Trial SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB05/041 GRANTED TO GILEAD SCIENCES, INC. IN RESPECT OF THE PRODUCT COMPOSITION CONTAINING BOTH TENOFOVIR DISOPROXIL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE, TAUTOMER OR SOLVATE THEREOF, TOGETHER WITH EMTRICITABINE , THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6233 DATED 05/11/2008 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 23/02/2020.
1419152 PA2012009 Lithuania ⤷  Free Forever Trial PRODUCT NAME: EMTRICITABINUM + RILPIVIRINUM + TENOFOVIRUM DISOPROXILUM; REGISTRATION NO/DATE: EU/1/11/737/001, 2011 11 28 EU/1/11/737/002 20111128
1663240 C 2015 038 Romania ⤷  Free Forever 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
0513200 91073 Luxembourg ⤷  Free Forever Trial 91073, EXPIRES: 20160131
1663240 1590056-6 Sweden ⤷  Free Forever Trial PRODUCT NAME: A COMBINATION OF RILPIVIRINE, OR A PHARMACEUTICALLY ACCEPTABLE SALT OF RILPIVIRINE, INCLUDING THE HYDROCHLORIDE SALT OF RILPIVIRINE, AND TENOFOVIR DISOPROXIL, IN PARTICULAR TENOFOVIR DISOPROXIL FUMARATE; REG. NO/DATE: EU/1/11/737 20111128
1663240 375 5032-2016 Slovakia ⤷  Free Forever Trial PRODUCT NAME: RILPIVIRIN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM/EMTRICITABIN/TENOFOVIR-ALAFENAMID VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/16/1112 20160623
1419152 92008 Luxembourg ⤷  Free Forever Trial 92008, EXPIRES: 20261128
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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