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Last Updated: June 17, 2024

EDURANT PED Drug Patent Profile


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When do Edurant Ped patents expire, and what generic alternatives are available?

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

This drug has two hundred and twenty-one patent family members in forty-five countries.

The generic ingredient in EDURANT PED 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 Ped

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 PED
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for EDURANT PED
Generic Entry Date for EDURANT PED*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET, FOR SUSPENSION;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 PED

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 PED clinical trials

US Patents and Regulatory Information for EDURANT PED

EDURANT PED is protected by two US patents.

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

Dispersible compositions
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

HIV inhibiting pyrimidines derivatives
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS FOR THE TREATMENT OF HIV-1 INFECTION IN ANTIRETROVIRAL TREATMENT-NAIVE PATIENTS 2 YEARS OF AGE AND OLDER, WEIGHING AT LEAST 14KG, WITH HIV-1 RNA LESS THAN OR EQUAL TO 100,000 AT THE START OF THERAPY

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 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

International Patents for EDURANT PED

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

Country Patent Number Title Estimated Expiration
Canada 2452217 DERIVES DE PYRIMIDINES INHIBITEURS DE VIH (HIV INHIBITING PYRIMIDINES DERIVATIVES) ⤷  Sign Up
Taiwan I338578 ⤷  Sign Up
Lithuania PA2016043 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for EDURANT PED

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1632232 122016000111 Germany ⤷  Sign Up PRODUCT NAME: KOMBINATION VON RILPIVIRINHYDROCHLORID ODER EINER THERAPEUTISCH AEQUIVALENTEN, DURCH DAS GRUNDPATENT GESCHUETZTEN FORM DAVON, EMTRICITABIN UND TENOFOVIRALAFENAMID ODER EINEM PHARMAZEUTISCH AKZEPTABLEN SALZ DAVON, INSBESONDERE TENOFOVIRALAFENAMIDFUMARAT; REGISTRATION NO/DATE: EU/1/16/1112 20160621
1663240 15C0073 France ⤷  Sign Up PRODUCT NAME: COMBINAISON DE RILPIVIRINE OU SES FORMES THERAPEUTIQUEMENT EQUIVALENTES PROTEGEES PAR LE BREVET DE BASE TELLES QUE LES SELS PHARMACEUTIQUEMENT ACCEPTABLES DE RILPIVIRINE Y COMPRIS LE SEL D'ACIDE CHLORHYDRIQUE DE RILPIVIRINE DE TENOFOVIR EN PARTICULIER LE TENOFOVIR DISOPROXIL FUMARATE AINSI QUE D'EMTRICITABINE; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
1663240 122015000085 Germany ⤷  Sign Up PRODUCT NAME: KOMBINATION VON RILPIVIRIN ODER EINER THERAPEUTISCH AEQUIVALENTEN FORM DAVON, DIE DURCH DAS GRUNDPATENT GESCHUETZT IST, WIE Z.B EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ VON RILPIVIRIN, EINSCHLIESSLICH DES HYDROCHLORIDSALZES VON RILPIVIRIN, UND EMTRICITABIN; 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.