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Last Updated: June 20, 2024

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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 two NDAs. There are three 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 October 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 Loss of Exclusivity (LOE) 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
ViiV HealthcarePhase 1/Phase 2
National Institute of Allergy and Infectious Diseases (NIAID)Phase 1/Phase 2

See all EDURANT clinical trials

US Patents and Regulatory Information for EDURANT

EDURANT is protected by one US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of EDURANT is ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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 ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Janssen Prods EDURANT PED rilpivirine hydrochloride TABLET, FOR SUSPENSION;ORAL 219016-001 Mar 15, 2024 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Janssen Prods EDURANT PED rilpivirine hydrochloride TABLET, FOR SUSPENSION;ORAL 219016-001 Mar 15, 2024 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>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 ⤷  Sign Up ⤷  Sign Up
Janssen Prods EDURANT rilpivirine hydrochloride TABLET;ORAL 202022-001 May 20, 2011 ⤷  Sign Up ⤷  Sign Up
Janssen Prods EDURANT rilpivirine hydrochloride TABLET;ORAL 202022-001 May 20, 2011 ⤷  Sign Up ⤷  Sign Up
Janssen Prods EDURANT rilpivirine hydrochloride TABLET;ORAL 202022-001 May 20, 2011 ⤷  Sign Up ⤷  Sign Up
>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
Canada 2398887 2,4,DI-(HETERO-) ARYLAMINO (-OXY)-5 PYRIMIDINES SUBSTITUTEESUTILISEES COMME AGENTS ANTINEOPLASIQUES (2,4,DI(HETERO-)ARYLAMINO(-OXY)-5-SUBSTITUTED PYRIMIDINES AS ANTINEOPLASTIC AGENTS) ⤷  Sign Up
New Zealand 553322 Furamate of 4-( (4-( (4- (2-cyanoethenyl) -2,6-dimethylphenyl)amino)-2-pyrimidinyl)amino)benzonitrile, also named TMC278 ⤷  Sign Up
Spain 2799408 ⤷  Sign Up
South Korea 101638999 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for EDURANT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1663240 C01663240/01 Switzerland ⤷  Sign Up FORMER OWNER: JANSSEN SCIENCES IRELAND UC, IE
1419152 CA 2012 00019 Denmark ⤷  Sign Up
1663240 222 6-2015 Slovakia ⤷  Sign Up PRODUCT NAME: EMTRICITABIN/RILPIVIRINHYDROCHLORID; REGISTRATION NO/DATE: EU/1/11/737/001 - EU/1/11/737/002 20111128
3808743 PA2022515 Lithuania ⤷  Sign Up PRODUCT NAME: RILPIVIRINO ARBA TERAPINIU POZIURIU EKVIVALENTISKOS JO FORMOS APSAUGOTOS PAGRINDINIU PATENTU, TOKIOS KAIP FARMACINIU POZIURIU PRIIMTINOS PRIDETINES RILPIVIRINO DRUSKOS, ISKAITANT RILPIVIRINO HIDROCHLORIDO RUGSTIES DRUSKA, IR EMTRICITABINO DERINYS; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
>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.