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Rilpivirine hydrochloride - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for rilpivirine hydrochloride?

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

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

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

Summary for Generic Name: rilpivirine hydrochloride

Tradenames:1
Patents:7
Applicants:1
NDAs:1
Drug Master File Entries: see list6
Suppliers / Packagers: see list1
Bulk Api Vendors: see list4
Clinical Trials: see list1,010
Patent Applications: see list12
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:rilpivirine hydrochloride at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Prods
EDURANT
rilpivirine hydrochloride
TABLET;ORAL202022-001May 20, 2011RXYesYes8,080,551► SubscribeYY ► Subscribe
Janssen Prods
EDURANT
rilpivirine hydrochloride
TABLET;ORAL202022-001May 20, 2011RXYesYes7,067,522► SubscribeYY ► Subscribe
Janssen Prods
EDURANT
rilpivirine hydrochloride
TABLET;ORAL202022-001May 20, 2011RXYesYes7,125,879► SubscribeYY ► Subscribe
Janssen Prods
EDURANT
rilpivirine hydrochloride
TABLET;ORAL202022-001May 20, 2011RXYesYes► Subscribe► Subscribe
Janssen Prods
EDURANT
rilpivirine hydrochloride
TABLET;ORAL202022-001May 20, 2011RXYesYes7,638,522► SubscribeY ► Subscribe
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Non-Orange Book Patents for Generic Ingredient: rilpivirine hydrochloride

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,956,063Salt of 4-[[4-[[4-(2-cyanoethenyl)-2,6-dimethylphenyl]amino]-2-pyrimidinyl- ]amino]benzonitrile► Subscribe
8,841,310Combinations of a pyrimidine containing NNRTI with RT inhibitors► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: rilpivirine hydrochloride

Country Document Number Estimated Expiration
Norway2014030► Subscribe
European Patent Office1663240► Subscribe
Hungary0401346► Subscribe
European Patent Office1419152► Subscribe
Costa Rica9031► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: RILPIVIRINE HYDROCHLORIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2015037Lithuania► SubscribePRODUCT NAME: RILPIVIRINUM + TENOFOVIRUM DISOPROXILUM + EMTRICITABINUM; REGISTRATION NO/DATE: EU/1/11/737/001 2011 11 28, EU/1/11/737/002 20111128
2012008,C1419152Lithuania► SubscribePRODUCT NAME: RILPIVIRINUM; REGISTRATION NO/DATE: EU/1/11/736/001 20111128
0853Netherlands► SubscribePRODUCT 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
4 5022-2015Slovakia► SubscribePRODUCT NAME: RILPIVIRINHYDROCHLORID/TENOFOVIRDIZOPROXILFUMARAT; REGISTRATION NO/DATE: EU/1/11/737/001 - EU/1/11/737/002 20111128
2016 00065Denmark► SubscribePRODUCT 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
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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