RILPIVIRINE HYDROCHLORIDE - Generic Drug Details

What are the generic sources for rilpivirine hydrochloride and what is the scope of patent protection?

Rilpivirine hydrochloride is the generic ingredient in two branded drugs marketed by Janssen Prods and is included in two NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Rilpivirine hydrochloride has two hundred and twenty-one patent family members in forty-five countries.

There are seven drug master file entries for rilpivirine hydrochloride. One supplier is listed for this compound.

Summary for RILPIVIRINE HYDROCHLORIDE

International Patents:	221
US Patents:	3
Tradenames:	2
Applicants:	1
NDAs:	2
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	26
Clinical Trials:	89
Patent Applications:	286
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for RILPIVIRINE HYDROCHLORIDE
What excipients (inactive ingredients) are in RILPIVIRINE HYDROCHLORIDE?	RILPIVIRINE HYDROCHLORIDE excipients list
DailyMed Link:	RILPIVIRINE HYDROCHLORIDE at DailyMed

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

Dosage:

TABLET;ORAL

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 RILPIVIRINE HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia	Phase 4
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 1/Phase 2
Janssen Research & Development, LLC	Phase 1/Phase 2

See all RILPIVIRINE HYDROCHLORIDE clinical trials

Pharmacology for RILPIVIRINE HYDROCHLORIDE

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

Medical Subject Heading (MeSH) Categories for RILPIVIRINE HYDROCHLORIDE

Anti-HIV Agents

Reverse Transcriptase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for RILPIVIRINE HYDROCHLORIDE

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 RILPIVIRINE HYDROCHLORIDE

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		DISCN	Yes	No			Y
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

Expired US Patents for RILPIVIRINE HYDROCHLORIDE

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 RILPIVIRINE HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Cyprus	1112331
Singapore	155885	FURAMATE OF 4-((4-((4-(2-CYANOETHENYL)-2,6-DIMETHYLPHENYL)AMINO)-2- PYRIMIDINYL)AMINO)BENZONITRILE
South Africa	200401159	HIV INHIBITING PYRIMIDINES DERIVATIVES
Denmark	1632232
Norway	20040633
Japan	2008511592
Norway	2014031

Supplementary Protection Certificates for RILPIVIRINE HYDROCHLORIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
2932970	LUC00090	Luxembourg		PRODUCT NAME: COMBINAISON COMPRENANT DU DOLUTEGRAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (PAR EXEMPLE LE DOLUTEGRAVIR SODIQUE) ET LA RILPIVIRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (PAR EXEMPLE LE CHLORHYDRATE DE RILPIVIRINE); AUTHORISATION NUMBER AND DATE: EU/1/18/1282 20180518
1663240	1590055-8	Sweden		PRODUCT NAME: A COMBINATION OF RILPIVIRINE OR A PHARMACEUTICALLYACCEPTABLE SALT OF RILPIVIRINE, INICLUDING THE HYDROCHLORIDE SALT OF RILPIVIRINE, AND EMTRICITABINE; REG. NO/DATE: EU/1/11/737 20111128
2932970	SPC/GB18/041	United Kingdom		PRODUCT NAME: A COMBINATION COMPRISING DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF (E.G. DOLUTEGRAVIR SODIUM) AND RILPIVIRINE OR A PHARAMACEUTICALLY ACCEPTABLE SALT THEREOF (E.G. RILPIVIRINE HYDROCHLORIDE); REGISTERED: UK EU/1/18/1282 20180518; UK PLGB 35728/0055 20180518; UK PLGB 35728/0056 20180518; UK PLGB 35728/0057 20180518
1419152	125 5007-2012	Slovakia		PRODUCT NAME: RILPIVIRIN; REGISTRATION NO/DATE: EU/1/11/736/001 20111128
3808743	2290034-4	Sweden		PRODUCT NAME: A COMBINATION OF RILPIVRINE OR A THERAPEUTICALLY EQIVALENT FORM THEREOF PROTECTED BY THE BASIC PATENT, SUCH AS A PHARMACEUTICALLY ACCEPTABLE ADDITION SALT OF RILPIVIRINE, INCLUDING THE HYDROCHLORIC ACID SALT OF RILPIVIRINE, AND EMTRICITABINE; REG. NO/DATE: EU/1/11/737/001-002 20111128
1632232	300853	Netherlands		PRODUCT NAME: COMBINATIE VAN: - RILPIVIRINEHYDROCHLORIDE OF EEN THERAPEUTISCH EQUIVALENTE VORM DAARVAN ZOALS BESCHERMD DOOR HET BASISOCTROOI; EN - TENOFOVIRALAFENAMIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER TENOFOVIRALAFENAMIDEFUMARAAT; REGISTRATION NO/DATE: EU/1/16/1112 20160623