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Rilpivirine hydrochloride - Generic Drug Details

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

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

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

Summary for rilpivirine hydrochloride

US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	7
Suppliers / Packagers:	1
Bulk Api Vendors:	9
Clinical Trials:	56
Patent Applications:	14
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for rilpivirine hydrochloride
DailyMed Link:	rilpivirine hydrochloride at DailyMed

Pharmacology for rilpivirine hydrochloride

Ingredient-type	Non-Nucleoside Analog
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

Synonyms for rilpivirine hydrochloride

212WAX8KDD

4-((4-((4-((1E)-2-Cyanoethenyl)-2,6-dimethylphenyl)amino)pyrimidin-2- yl)amino)benzonitrile

4-[[4-[4-[(E)-2-cyanoethenyl]-2,6-dimethylanilino]pyrimidin-2-yl]amino]benzonitrile;hydrochloride

4-{[4-({4-[(E)-2-cyanoethenyl]-2,6-dimethylphenyl}amino)pyrimidin-2-yl]amino}benzonitrile hydrochloride

4-{[4-({4-[(E)-2-cyanovinyl]-2,6-dimethylphenyl}amino)pyrimidin-2-yl]amino}benzonitrile hydrochloride

700361-47-3

AKOS025149454

BC677097

Benzonitrile, 4-((4-((4-((1E)-2-cyanoethenyl)-2,6-dimethylphenyl)amino)-2- pyrimidinyl)amino)-, hydrochloride (1:1)

Benzonitrile, 4-((4-((4-((1e)-2-cyanoethenyl)-2,6-dimethylphenyl)amino)-2-pyrimidinyl)amino)-, hydrochloride (1:1)

CHEBI:68602

CHEMBL1628504

D09958

DTXSID80220320

Edurant

Edurant (TN)

Endurant

KZVVGZKAVZUACK-BJILWQEISA-N

R-278474

Rilpivirine HCl

Rilpivirine hydrochloride (JAN/USAN)

Rilpivirine hydrochloride [USAN]

rilpivirine monohydrochloride

RILPIVIRINEHCL

SCHEMBL1831067

TMC-278-LA

TMC278 hydrochloride

TMC278-HYDROCHLORIDE

UNII-212WAX8KDD

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

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International Patents for rilpivirine hydrochloride

Country	Document Number	Estimated Expiration
Norway	2014031
South Africa	200601820
Hungary	E025576
Portugal	1632232

Supplementary Protection Certificates for rilpivirine hydrochloride

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
12/017	Ireland		PRODUCT NAME: RILPIVIRINE OR A PHARMACEUTICALLY ACCEPTABLE ADDITION SALT THEREOF, INCLUDING THE HYDROCHLORIC ACID SALT OF RILPIVIRINE; REGISTRATION NO/DATE: EU/1/11/736/001 20111128
90017-1	Sweden		PRODUCT NAME: RILPIVIRIN OCH FARMACEUTISKT GODTAGBARA ADDITIONSSALTER DAERAV, INBEGRIPET VAETEKLORSYRASALTET AV RILPIVIRIN; REG. NO/DATE: EU/1/11/736/001 20111128
0120010 00057	Estonia		PRODUCT NAME: EDURANT - RILPIVIRIIN;REG NO/DATE: C(2011)8955 FINAL 28.11.2011
2016 00065	Denmark		PRODUCT NAME: EN KOMBINATION AF: RILPIVIRINHYDROCHLORID ELLER EN TERAPEUTISK AEKVIVALENT FORM DERAF SOM ER BESKYTTET AF GRUNDPATENTET, OG TENOFOVIRALAFENAMID, ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, SAERLIGT TENOFOVIRALAFENAMIDFUMARAT; REG. NO/DATE: EU/1/16/1112/001 20160623