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EDURANT Drug Patent Profile

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

Summary for EDURANT

International Patents:	199
US Patents:	1
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	122
Clinical Trials:	14
Patent Applications:	1,146
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for EDURANT
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EDURANT
What excipients (inactive ingredients) are in EDURANT?	EDURANT excipients list
DailyMed Link:	EDURANT at DailyMed

See drug prices for EDURANT

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for EDURANT

NDA:

202022

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

Sponsor	Phase
Aptorum International Limited	Phase 1
National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1/Phase 2
ViiV Healthcare	Phase 1/Phase 2

See all EDURANT clinical trials

Pharmacology for EDURANT

Drug Class	Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor
Mechanism of Action	Non-Nucleoside Reverse Transcriptase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for EDURANT

J05AG	Non-nucleoside reverse transcriptase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for EDURANT

EDURANT is protected by one US patents.

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

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					Y
Janssen Prods	EDURANT PED	rilpivirine hydrochloride	TABLET, FOR SUSPENSION;ORAL	219016-001	Mar 15, 2024		RX	Yes	Yes			Y	Y
Janssen Prods	EDURANT PED	rilpivirine hydrochloride	TABLET, FOR SUSPENSION;ORAL	219016-001	Mar 15, 2024		RX	Yes	Yes			Y

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
Janssen Prods	EDURANT	rilpivirine hydrochloride	TABLET;ORAL	202022-001	May 20, 2011
Janssen Prods	EDURANT	rilpivirine hydrochloride	TABLET;ORAL	202022-001	May 20, 2011
Janssen Prods	EDURANT	rilpivirine hydrochloride	TABLET;ORAL	202022-001	May 20, 2011
Janssen Prods	EDURANT	rilpivirine hydrochloride	TABLET;ORAL	202022-001	May 20, 2011

International Patents for EDURANT

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

Country	Patent Number	Title	Estimated Expiration
Norway	2014032
South Africa	200701826	Furamate of 4-[[4-[[4-(2-cyanoethenyl)-2,6-dimethylphenyl] amino]-2-pyrimidinyl]amino]benzonitrile
Israel	173438	COMBINATIONS OF A PYRIMIDINYL-AMINO-BENZONITRILE DERIVATIVE, TENOFOVIR AND OPTIONALLY EMTRICITABINE IN THE MANUFACTURE OF A MEDICAMENT GIVEN ONCE DAILY TO TREAT HIV
Japan	4838396
Croatia	P20040096	HIV INHIBITING PYRIMIDINES DERIVATIVES
South Africa	200401159	HIV INHIBITING PYRIMIDINES DERIVATIVES

Supplementary Protection Certificates for EDURANT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1632232	122016000111	Germany		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		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		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
1663240	132016000129162	Italy		PRODUCT NAME: ASSOCIAZIONE DI RILPIVIRINA O UNA SUA FORMA TERAPEUTICAMENTE EQUIVALENTE PROTETTA DAL BREVETTO DI BASE, COME UN SALE FARMACEUTICAMENTE ACCETTABILE DI RILPIVIRINA, COMPRESO IL SUO SALE CLORIDRATO, EMTRICITABINA, E TENOFOVIR ALAFENAMIDE O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE, IN PARTICOLARE IL TENOFOVIR ALAFENAMIDE EMIFUMARATO(ODEFSEY); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1112, 20160623
1663240	300850	Netherlands		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
1663240	PA2015038	Lithuania		PRODUCT NAME: RILPIVIRINUM + TENOFOVIRUM DISOPROXILUM; REGISTRATION NO/DATE: EU/1/11/737/001, 2011 11 28, EU/1/11/737/002 20111128