Rilpivirine hydrochloride - Generic Drug Details

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

Rilpivirine hydrochloride is the generic ingredient in one branded drug marketed by Janssen Prods and is included in one NDA. There are four patents 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:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	25
Clinical Trials:	85
Patent Applications:	318
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

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

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	See Plans and Pricing	See Plans and Pricing	Y	Y		See Plans and Pricing
Janssen Prods	EDURANT	rilpivirine hydrochloride	TABLET;ORAL	202022-001	May 20, 2011		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing	Y			See Plans and Pricing
Janssen Prods	EDURANT	rilpivirine hydrochloride	TABLET;ORAL	202022-001	May 20, 2011		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing	Y	Y		See Plans and Pricing
Janssen Prods	EDURANT	rilpivirine hydrochloride	TABLET;ORAL	202022-001	May 20, 2011		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing	Y			See Plans and Pricing
>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	See Plans and Pricing	See Plans and Pricing
Janssen Prods	EDURANT	rilpivirine hydrochloride	TABLET;ORAL	202022-001	May 20, 2011	See Plans and Pricing	See Plans and Pricing
Janssen Prods	EDURANT	rilpivirine hydrochloride	TABLET;ORAL	202022-001	May 20, 2011	See Plans and Pricing	See Plans and Pricing
>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
Eurasian Patent Organization	014840	КОМБИНАЦИИ ПИРИМИДИНСОДЕРЖАЩЕГО NNRTI С ИНГИБИТОРАМИ ОБРАТНОЙ ТРАНСКРИПТАЗЫ (COMBINATIONS OF A PYRIMIDINE CONTAINING NNRTI WITH RT INHIBITORS)	See Plans and Pricing
Hungary	S1500053		See Plans and Pricing
Poland	402388	Pochodna pirymidyny, jej zastosowanie i kompozycja farmaceutyczna ja zawierajaca (Pyrimidine derivative, its use and a pharmaceutical composition containing it)	See Plans and Pricing
Japan	2015044839	ピリミジンを含有するＮＮＲＴＩとＲＴインヒビターとの組み合わせ物 (COMBINATION OF NNRTI CONTAINING PYRIMIDINE WITH RT INHIBITOR)	See Plans and Pricing
Japan	2007520443		See Plans and Pricing
>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	628	Finland	See Plans and Pricing
1663240	2015/054	Ireland	See Plans and Pricing	PRODUCT NAME: A COMBINATION OF RILPIVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING THE HYDROCHLORIDE SALT, AND TENOFOVIR, IN PARTICULAR TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
1663240	PA2015035,C1663240	Lithuania	See Plans and Pricing	PRODUCT NAME: RILPIVIRINO ARBA TERAPINIU POZIURIU PRIIMTINOS JO FORMOS, TOKIOS KAIP RILPIVIRINO DRUSKOS,ISKAITANT RILPIVIRINO HIDROCHLORIDA, IR EMTRICITABINO DERINYS; REGISTRATION NO/DATE: EU/1/11/737/001, 2011 11 28 EU/1/11/737/002 20111128
1419152	SPC/GB12/022	United Kingdom	See Plans and Pricing	PRODUCT NAME: RILPIVIRINE, A N-OXIDE, A PHARMACEUTICALLY ACCEPTABLE ADDITION SALT INCLUDING THE HYDROCHLORIC ACID SALT, OR A QUATERNARY AMINE THEREOF.; REGISTERED: UK EU/1/11/736/001 20111128
1419152	125 5007-2012	Slovakia	See Plans and Pricing	PRODUCT NAME: RILPIVIRIN; REGISTRATION NO/DATE: EU/1/11/736/001 20111128
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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