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Last Updated: February 4, 2023

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.

Recent Clinical Trials for rilpivirine hydrochloride

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

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

See all rilpivirine hydrochloride clinical trials

Medical Subject Heading (MeSH) Categories for rilpivirine hydrochloride

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 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

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

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

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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Serving leading biopharmaceutical companies globally:

McKesson
Boehringer Ingelheim
AstraZeneca
Moodys
Merck
McKinsey

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