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Last Updated: July 6, 2020

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COMPLERA Drug 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 eleven patents protecting this drug and one Paragraph IV challenge.

This drug has four hundred and fifty-nine patent family members in fifty-one 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.

US ANDA Litigation and 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 December 9, 2025. 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

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Drug patent expirations by year for COMPLERA
Drug Prices for COMPLERA

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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
CIHR Canadian HIV Trials NetworkPhase 3
Gilead SciencesPhase 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   Start Trial   Start Trial Y   Start Trial
Gilead Sciences Inc COMPLERA emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate TABLET;ORAL 202123-001 Aug 10, 2011 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Gilead Sciences Inc COMPLERA emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate TABLET;ORAL 202123-001 Aug 10, 2011 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Gilead Sciences Inc COMPLERA emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate TABLET;ORAL 202123-001 Aug 10, 2011 RX Yes Yes   Start Trial   Start Trial Y   Start 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

Supplementary Protection Certificates for COMPLERA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1663240 300850 Netherlands   Start Trial PRODUCT NAME: COMBINATIE VAN: -RILPIVIRINE OF EEN THERAPEUTISCH EQUIVALENTE VORM DAARVAN ZOALS BESCHERMD DOOR HET BASISOCTROOI, ZOALS EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN RILPIVIRINE, WAARONDER HET HYDROCHLORIDEZOUT VAN RILPIVIRINE; EN -TENOFOVIRALAFENAMIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER TENOFOVIRALAFENAMIDEFUMARAAT; REGISTRATION NO/DATE: EU/1/16/1112 20160623
1419152 132012902054377 Italy   Start Trial PRODUCT NAME: EMTRICITABINA/RILPIVIRINA CLORIDRATO/TENOFOVIR DISOPROXIL FUMARATO(EVIPLERA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/11/737/001-002, 20111128
1419152 C01419152/02 Switzerland   Start Trial PRODUCT NAME: RILPIVIRIN UND TENOFOVIR; REGISTRATION NO/DATE: SWISSMEDIC 62155 12.03.2013
1419152 12C0036 France   Start Trial PRODUCT NAME: COMBINAISON DE RILPIVIRINE ET TOUTES SES FORMES THERAPEUTIQUEMENT EQUIVALENTES PROTEGEES PAR LE BREVET DE BASE, TELLES QUE LES SELS D'ADDITION PHARMACEUTIQUEMENT ACCEPTABLES DE RILPIVIRINE, Y COMPRIS LE SEL D'ACIDE CHLORHYDRIQUE DE RILPIVIRINE ET DE TENOFOVIR, EN PARTICULIER LE TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/11/737/001 20111128
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
AstraZeneca
Mallinckrodt
Merck
Dow
Johnson and Johnson

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