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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 freedom to operate?

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.

Rilpivirine hydrochloride has two hundred and thirteen patent family members in thirty-nine countries.

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

Summary for rilpivirine hydrochloride

International Patents:	213
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	7
Suppliers / Packagers:	1
Bulk Api Vendors:	9
Clinical Trials:	62
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

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			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	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
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

International Patents for rilpivirine hydrochloride

Country	Document Number	Estimated Expiration
Slovenia	1663240
Hungary	0401346
Japan	4922937
South Africa	200701826
Eurasian Patent Organization	200700534
Portugal	1419152
South Korea	20070074555

Supplementary Protection Certificates for rilpivirine hydrochloride

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0853	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
2015000087	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
2016000108	Germany		PRODUCT NAME: KOMBINATION VON RILPIVIRIN ODER EINER THERAPEUTISCH AEQUIVALENTEN, DURCH DAS GRUNDPATENT GESCHUETZTEN FORM DAVON, Z.B. EINEM PHARMAZEUTISCH AKZEPTABLEN SALZ VON RILPIVIRIN, EINSCHLIESSLICH DES HYDROCHLORIDSALZES VON RILPIVIRIN, UND TENOFOVIRALAFENAMID ODER EINEM PHARMAZEUTISCH AKZEPTABLEN SALZ DAVON, INSBESONDERE TENOFOVIRALAFENAMIDFUMARAT; REGISTRATION NO/DATE: EU/1/16/1112 20160621
855	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 , TENOFOVIR, EN PARTICULIER LE FUMARATE DE TENOFOVIR DISOPROXIL, ET L'EMTRICITABINE.
2012 00019	Denmark		PRODUCT NAME: RILPIVIRIN OG FARMACEUTISK ACCEPTABLE ADDITIONSSALTE DERAF, HERUNDER HYDROGENCHLORIDSALTET AF RILPIVIRIN; REG. NO/DATE: EU/1/11/736/001 20111128
2015038	Lithuania		PRODUCT NAME: RILPIVIRINUM + TENOFOVIRUM DISOPROXILUM; REGISTRATION NO/DATE: EU/1/11/737/001, 2011 11 28, EU/1/11/737/002 20111128
2015035	Lithuania		PRODUCT NAME: RIPALVIRINUM + EMTRICITABINUM; REGISTRATION NO/DATE: EU/1/11/737/001, 2011 11 28 EU/1/11/737/002 20111128