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Last Updated: October 1, 2022

EDURANT Drug Patent Profile


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Which patents cover Edurant, and what generic alternatives are available?

Edurant is a drug marketed by Janssen Prods and is included in one NDA. There are four patents protecting this drug.

This drug has one hundred and ninety-nine patent family members in forty-two countries.

The generic ingredient in EDURANT is rilpivirine hydrochloride. There are seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the rilpivirine hydrochloride profile page.

DrugPatentWatch® Generic Entry Outlook for Edurant

Edurant 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 April 21, 2025. This may change due to patent challenges or generic licensing.

There have been three 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 EDURANT
Drug Prices for EDURANT

See drug prices for EDURANT

DrugPatentWatch® Estimated Generic Entry Opportunity Date for EDURANT
Generic Entry Date for EDURANT*:
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 EDURANT

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Aptorum International LimitedPhase 1
National Institute of Allergy and Infectious Diseases (NIAID)Phase 1/Phase 2
ViiV HealthcarePhase 1/Phase 2

See all EDURANT clinical trials

US Patents and Regulatory Information for EDURANT

EDURANT is protected by seven US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of EDURANT 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 EDURANT

HIV inhibiting pyrimidines derivatives
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS FOR THE TREATMENT OF HIV-1 INFECTION IN TREATMENT-NAIVE PATIENTS WITH HIV-1 RNA LESS THAN OR EQUAL TO 100,000 AT THE START OF THEARPY

HIV inhibiting pyrimidines derivatives
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS, IS INDICATED FOR THE TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 (HIV-1) INFECTION IN ANTIRETROVIRAL TREATMENT-NAIVE ADULT PATIENTS, AS SET FORTH IN THE LABELING, INCLUDING I&U SECTION

HIV inhibiting pyrimidines derivatives
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT IN COMBINATION WITH CABOTEGRAVIR OF HIV-1 INFECTION IN ADULTS AND ADOLESCENTS 12 AND OLDER TO REPLACE CURRENT REGIMEN IN THOSE WHO ARE VIROLOGICALLY SUPPRESSED ON A STABLE ANTIRETROVIRAL REGIMEN WITH NO HISTORY OF TREATMENT FAILURE

HIV inhibiting pyrimidines derivatives
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS FOR THE TREATMENT OF HIV-1 INFECTION IN TREATMENT-NAIVE ADULT PATIENTS WITH HIV-1 RNA LESS THAN OR EQUAL TO 100,000 AT THE START OF THERAPY

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

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

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Prods EDURANT rilpivirine hydrochloride TABLET;ORAL 202022-001 May 20, 2011 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Janssen Prods EDURANT rilpivirine hydrochloride TABLET;ORAL 202022-001 May 20, 2011 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Janssen Prods EDURANT rilpivirine hydrochloride TABLET;ORAL 202022-001 May 20, 2011 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Janssen Prods EDURANT rilpivirine hydrochloride TABLET;ORAL 202022-001 May 20, 2011 RX Yes Yes See Plans and Pricing See Plans and Pricing 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 EDURANT

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Prods EDURANT rilpivirine hydrochloride TABLET;ORAL 202022-001 May 20, 2011 See Plans and Pricing See Plans and Pricing
Janssen Prods EDURANT rilpivirine hydrochloride TABLET;ORAL 202022-001 May 20, 2011 See Plans and Pricing See Plans and Pricing
Janssen Prods EDURANT rilpivirine hydrochloride TABLET;ORAL 202022-001 May 20, 2011 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for EDURANT

See the table below for patents covering EDURANT around the world.

Country Patent Number Title Estimated Expiration
South Korea 20070101409 HIV INHIBITING PYRIMIDINES DERIVATIVES See Plans and Pricing
Norway 2016025 See Plans and Pricing
China 101060844 Combinations of a pyrimidine containing nnrti with rt inhibitors See Plans and Pricing
Brazil PI0514861 furamato de 4-((4-((4-(2-cianoetenil)-2,6-dimetilfenil)amino)-2-pirimidi nil)amino)benzonitrila See Plans and Pricing
Norway 20071745 See Plans and Pricing
Norway 20040633 See Plans and Pricing
Lithuania PA2016044 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for EDURANT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3808743 301190 Netherlands See Plans and Pricing PRODUCT NAME: EEN COMBINATIE VAN RILPIVIRINE OF EEN DOOR HET BASISOCTROOI BESCHERMDE THERAPEUTISCH EQUIVALENTE VORM DAARVAN, ZOALS EEN FARMACEUTISCH AANVAARDBAAR ADDITIEZOUT VAN RILPIVIRINE, MET INBEGRIP VAN HET HYDROCHLORIDE-ZOUT VAN RILPIVIRINE, EN EMTRICITABINE; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
2932970 2018C/041 Belgium See Plans and Pricing PRODUCT NAME: EEN COMBINATIE OMVATTENDE DOLUTEGRAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN (BIJVOORBEELD DOLUTEGRAVIRNATRIUM) EN RILPIVIRINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN (BIJVOORBEELD RILPIVIRINEHYDROCHLORIDE); AUTHORISATION NUMBER AND DATE: EU/1/18/1282 20180518
1663240 C 2015 038 Romania See Plans and Pricing 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
2932970 LUC00090 Luxembourg See Plans and Pricing PRODUCT NAME: COMBINAISON COMPRENANT DU DOLUTEGRAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (PAR EXEMPLE LE DOLUTEGRAVIR SODIQUE) ET LA RILPIVIRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (PAR EXEMPLE LE CHLORHYDRATE DE RILPIVIRINE); AUTHORISATION NUMBER AND DATE: EU/1/18/1282 20180518
1419152 132012902054377 Italy See Plans and Pricing PRODUCT NAME: EMTRICITABINA/RILPIVIRINA CLORIDRATO/TENOFOVIR DISOPROXIL FUMARATO(EVIPLERA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/11/737/001-002, 20111128
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 19/2012 Austria See Plans and Pricing PRODUCT NAME: RILPIVIRIN UND PHARMAZEUTISCH ANNEHMBARE ADDITIONSSALZE VON RILPIVIRIN, ENSCHLIESSLICH DEM HYDROCHLORID VON RILPIVIRIN; REGISTRATION NO/DATE: EU/1/11/736/001 (MITTEILUNG) 20111130
>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.