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Last Updated: June 25, 2021

DrugPatentWatch Database Preview

EDURANT Drug 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 five patents protecting this drug.

This drug has two hundred and twenty-three patent family members in forty-one 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 two 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

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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
National Institute of Allergy and Infectious Diseases (NIAID)Phase 1/Phase 2
Johnson & Johnson Pte LtdPhase 3
University of LiverpoolPhase 2

See all EDURANT clinical trials

US Patents and Regulatory Information for EDURANT

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   Get Started Free   Get Started Free Y Y   Get Started Free
Janssen Prods EDURANT rilpivirine hydrochloride TABLET;ORAL 202022-001 May 20, 2011 RX Yes Yes   Get Started Free   Get Started Free Y   Get Started Free
Janssen Prods EDURANT rilpivirine hydrochloride TABLET;ORAL 202022-001 May 20, 2011 RX Yes Yes   Get Started Free   Get Started Free Y   Get Started Free
Janssen Prods EDURANT rilpivirine hydrochloride TABLET;ORAL 202022-001 May 20, 2011 RX Yes Yes   Get Started Free   Get Started Free Y Y   Get Started Free
>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   Get Started Free   Get Started Free
Janssen Prods EDURANT rilpivirine hydrochloride TABLET;ORAL 202022-001 May 20, 2011   Get Started Free   Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for EDURANT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2932970 1890039-9 Sweden   Get Started Free PRODUCT NAME: DOLUTEGRAVIR SODIUM + RILPIVIRINE HYDROCHLORIDE; REG. NO/DATE: EU/1/18/1282 20180518
1632232 122016000110 Germany   Get Started Free PRODUCT NAME: KOMBINATION VON RILPIVIRINHYDROCHLORID ODER EINER THERAPEUTISCH AEQUIVALENTEN, DURCH DAS GRUNDPATENT GESCHUETZTEN FORM DAVON UND TENOFOVIRALAFENAMID ODER EINEM PHARMAZEUTISCH AKZEPTABLEN SALZ DAVON, INSBESONDERE TENOFOVIRALAFENAMIDFUMARAT; REGISTRATION NO/DATE: EU/1/16/1112 20160621
1632232 PA2016043 Lithuania   Get Started Free PRODUCT NAME: RILPIVIRINO HIDROCHLORIDAS + TENOFOVIRO ALAFENAMIDAS; REGISTRATION NO/DATE: EU/1/16/1112 20160621
1419152 2012/017 Ireland   Get Started Free PRODUCT NAME: RILPIVIRINE OR A PHARMACEUTICALLY ACCEPTABLE ADDITION SALT THEREOF, INCLUDING THE HYDROCHLORIC ACID SALT OF RILPIVIRINE; REGISTRATION NO/DATE: EU/1/11/736/001 20111128
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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