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EDURANT Drug Patent Profile

Which patents cover Edurant, and when can generic versions of Edurant launch?

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
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

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		DISCN	Yes	No			Y	Y
Janssen Prods	EDURANT PED	rilpivirine hydrochloride	TABLET, FOR SUSPENSION;ORAL	219016-001	Mar 15, 2024		DISCN	Yes	No			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
Slovenia	1419152
Singapore	155885	FURAMATE OF 4-((4-((4-(2-CYANOETHENYL)-2,6-DIMETHYLPHENYL)AMINO)-2- PYRIMIDINYL)AMINO)BENZONITRILE
European Patent Office	1632232	Sel de 4-[[4-[[4-(2-Cyanoethenyl)-2,6-dimethylphenyl]amino]-2-Pyrimidinyl]amino]benzonitrile (Salt of 4[[4-[[4-(2-Cyanoethenyl)-2,6-dimethylphenyl]amino]-2-Pyrimidinyl]amino]benzonitrile)
Croatia	P20040096	HIV INHIBITING PYRIMIDINES DERIVATIVES
Luxembourg	92008
Poland	1663240
Norway	340654

Supplementary Protection Certificates for EDURANT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1663240	375 5032-2016	Slovakia		PRODUCT NAME: RILPIVIRIN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM/EMTRICITABIN/TENOFOVIR-ALAFENAMID VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/16/1112 20160623
1663240	CA 2016 00063	Denmark		PRODUCT NAME: RILPIVIRIN ELLER TERAPEUTISK AEKVIVALENT FORM DERAF BESKYTTET AF GRUNDPATENTET SASOM ET FARMACEUTISK ACCEPTABELT SALT FX HYDROCHLORIDSALTET AF RILPIVIRIN OG TENOFOVIRALAFENAMID ELLER FARMACEUTISK ACCEPTABELT SALT DERAF FX TENOFOVIRALAFENAMIDFUMARAT; REG. NO/DATE: EU/1/16/1112/001 20160623
1419152	C 2012 015	Romania		PRODUCT NAME: RILPIVIRINA SI TOATE FORMELE ECHIVALENTE TERAPEUTIC ALEACESTEIA CUM AR FI SARURILE DE ADITIE ALE RILPIVIRINEI ACCEPTABILE FARMACEUTIC, INCLUSIV SAREA RILPIVIRINEI CU ACIDULCLORHIDRIC; NATIONAL AUTHORISATION NUMBER: RO EU/1/11/736/001; DATE OF NATIONAL AUTHORISATION: 20111128; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/11/736/001; DATE OF FIRST AUTHORISATION IN EEA: 20111128
1663240	CA 2016 00064	Denmark		PRODUCT NAME: KOMBINATION AF: RILPIVIRINHYDROCHLORID ELLER EN TERAPEUTISK AEKVIVALENT FORM DERAF SOM ER BESKYTTET AF GRUNDPATENTET, EMTRICITABIN OG TENOFOVIRALAFENAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF SAERLIGT TENOFOVIRALAFENAMIDFUMARAT; REG. NO/DATE: EU/1/16/1112/001 20160623
1419152	CR 2012 00019	Denmark		PRODUCT NAME: RILPIVIRIN OG FARMACEUTISK ACCEPTABLE ADDITIONSSALTE DERAF, HERUNDER HYDROGENCHLORIDSALTET AF RILPIVIRIN; REG. NO/DATE: EU/1/11/736/001 20111128
1663240	122015000087	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 TENOFOVIR, INSBESONDERE TENOFOVIRDISOPROXILFUMARAT; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
3808743	C20220027 00378	Estonia		PRODUCT NAME: EMTRITSITABIIN/ RILPIVIRIIN;REG NO/DATE: EU/1/11/737 28.11.2011