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Last Updated: April 25, 2024

Rilpivirine hydrochloride - Generic Drug Details

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What are the generic drug sources for rilpivirine hydrochloride and what is the scope of freedom to operate?

Rilpivirine hydrochloride is the generic ingredient in one branded drug marketed by Janssen Prods and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Rilpivirine hydrochloride has one hundred and ninety-nine patent family members in forty-two countries.

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

Summary for rilpivirine hydrochloride

International Patents:	199
US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	26
Clinical Trials:	87
Patent Applications:	286
Formulation / Manufacturing:	see details
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

Generic Entry Date for rilpivirine hydrochloride^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial 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 rilpivirine hydrochloride

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

Sponsor	Phase
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 1/Phase 2
Janssen Research & Development, LLC	Phase 1/Phase 2
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)	Phase 3

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

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Glossary

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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	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for rilpivirine hydrochloride

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Prods	EDURANT	rilpivirine hydrochloride	TABLET;ORAL	202022-001	May 20, 2011	⤷ Try a Trial	⤷ Try a Trial
Janssen Prods	EDURANT	rilpivirine hydrochloride	TABLET;ORAL	202022-001	May 20, 2011	⤷ Try a Trial	⤷ Try a Trial
Janssen Prods	EDURANT	rilpivirine hydrochloride	TABLET;ORAL	202022-001	May 20, 2011	⤷ Try a Trial	⤷ Try a Trial
Janssen Prods	EDURANT	rilpivirine hydrochloride	TABLET;ORAL	202022-001	May 20, 2011	⤷ Try a Trial	⤷ Try a Trial
Janssen Prods	EDURANT	rilpivirine hydrochloride	TABLET;ORAL	202022-001	May 20, 2011	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for rilpivirine hydrochloride

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Country	Patent Number	Title	Estimated Expiration
China	101056673	Hydrochloride of 4-((4-(4-(2-cyanoethenyl)-2,6-dimethylphenyl)amino)-2-pyrimidinyl)amino)benzonitrile	⤷ Try a Trial
Norway	2017065		⤷ Try a Trial
New Zealand	553323	Hydrochloride of 4-[[4-[[4-(2-cyanoethenyl)-2,6-dimethylphenyl]amino]-2-pyrimidinyl]amino]benzonitrile, also named TMC278	⤷ Try a Trial
Australia	2014203484	Combinations of a pyrimidine containing NNRTI with RT inhibitors	⤷ Try a Trial
Norway	340654		⤷ Try a Trial
Netherlands	300781		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for rilpivirine hydrochloride

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1419152	CR 2012 00021	Denmark	⤷ Try a Trial	PRODUCT NAME: KOMBINATION AF RILPIVIRIN ELLER ET FARMACEUTISK ACCEPTABELT ADDITIONSSALT AF RILPIVIRIN, HERUNDER HYDROCHLORID ADDITIONSSALTET AF RILPIVIRIN, OG TENOFOVIR, NAVNLIG TENOFOVIRDISOPROXILFUMARAT; REG. NO/DATE: EU/1/11/737/001-002 20111128
1663240	PA2015035	Lithuania	⤷ Try a Trial	PRODUCT NAME: RIPALVIRINUM + EMTRICITABINUM; REGISTRATION NO/DATE: EU/1/11/737/001, 2011 11 28 EU/1/11/737/002 20111128
1419152	162 5010-2012	Slovakia	⤷ Try a Trial	PRODUCT NAME: RILPIVIRINHYDROCHLORID/TENOFOVIRDIZOPROXILFUMARAT; REGISTRATION NO/DATE: EU/1/11/737/001 - EU/1/11/737/002 20111128
2932970	LUC00090	Luxembourg	⤷ Try a Trial	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
1419152	PA2012008,C1419152	Lithuania	⤷ Try a Trial	PRODUCT NAME: RILPIVIRINUM; REGISTRATION NO/DATE: EU/1/11/736/001 20111128
2932970	SPC/GB18/041	United Kingdom	⤷ Try a Trial	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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