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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 is one patent 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

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
Serbia	51923	SO 4[[4-[[4-(2-CIJANOETENIL)-2,6-DIMETILFENIL]AMINO]-2- PIRIMIDINIL]AMINO]BENZONITRILA (Salt of [[4-[[4-(2-Cyanoethenyl)-2,6-dimethylphenyI]amino]-2-, Pyrimidinyl]amino]benzonitrile)
Montenegro	01246	SO 4[[4-[[4-(2-CIJANOETENIL)-2,6-DIMETILFENIL]AMINO]-2-PIRIMIDINIL]AMINO]BENZONITRILA (SALT OF 4[[4-[[4-(2-CYANOETHENYL)-2,6-DIMETHYLPHENYL]AMINO]-2-PYRIMIDINYL]AMINO]BENZONITRILE)
Taiwan	I272945
China	1541215	抑制HIV的嘧啶衍生物 (HIV inhibiting pyrimidines derivatives)
Poland	216398
Eurasian Patent Organization	200700536	ГИДРОХЛОРИД 4-[[4-[[4-(2-ЦИАНОЭТЕНИЛ)-2,6-ДИМЕТИЛФЕНИЛ]АМИНО]-2-ПИРИМИДИНИЛ]АМИНО]БЕНЗОНИТРИЛА
Hong Kong	1210029	-氰基乙烯基 -二甲基苯基 氨基 -嘧啶基 氨基 苄腈的鹽酸鹽 (HYDROCHLORIDE OF 4-[[4-[[4-(2-CYANOETHENYL)-2,6- DIMETHYLPHENYL]AMINO]-2- PYRIMIDINYL]AMINO]BENZONITRILE 4-[[4-[[4-(2-)-26-]]-2-]])

Supplementary Protection Certificates for EDURANT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3808743	2022C/531	Belgium		PRODUCT NAME: EEN COMBINATIE VAN RILPIVIRINE OF EEN FARMACEUTISCH AANVAARDBAAR ADDITIEZOUT VAN RILPIVIRINE, EN EMTRICITABINE; AUTHORISATION NUMBER AND DATE: EU/1/11/737/001-002 20111128
1663240	C20150039 00166	Estonia		PRODUCT NAME: RILPIVIRIINI (VESINIKKLORIIDSOOLANA) JA EMTRITSITABIINI;REG NO/DATE: EU/1/11/737/001-002 28.11.2011
1663240	300851	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; - EMTRICITABINE; EN - TENOFOVIRALAFENAMIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER TENOFOVIRALAFENAMIDEFUMARAAT; REGISTRATION NO/DATE: EU/1/16/1112 20160623
1663240	224 5022-2015	Slovakia		PRODUCT NAME: RILPIVIRINHYDROCHLORID/TENOFOVIRDIZOPROXILFUMARAT; REGISTRATION NO/DATE: EU/1/11/737/001 - EU/1/11/737/002 20111128
1663240	1690062-3	Sweden		PRODUCT NAME: A COMBINATION OF: RILPIVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT OF RILPIVIRINE, INCLUDING THE HYDROCHLORIDE SALT OF RILPIVIRINE; EMTRICITABINE; AND TENOFOVIR ALAFENAMIDE, OR A PHARMCEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING TENOFOVIR ALAFENAMIDE FUMARATE.; REG. NO/DATE: EU/1/16/1112 20160623
1663240	92854	Luxembourg		PRODUCT NAME: COMBINAISON DE RILPIVIRINE OU UNE FORME THERAPEUTIQUE EQUIVALENTE QUI EN DERIVE TELLE QUE PROTEGEE PAR LE BREVET DE BASE, TEL QU'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE RILPIVIRINE, INCLUANT LE SEL CHLORHYDRATE DE RILPIVIRINE, ET TENOFOVIR, EN PARTICULIER LE FUMARATE DE TENOFOVIR DISOPROXIL
1663240	15C0072	France		PRODUCT NAME: VOIR LA RUBRIQUE 5 DE LA REQUETE EN DELIVRANCE DU CCP 15C0072 DATANT DU 09/05/2018 DANS L'ONGLET "DOCUMENTS"; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128