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Serving leading biopharmaceutical companies globally:

Queensland Health
Cantor Fitzgerald
Citi
Covington
Julphar
Dow
McKesson
Johnson and Johnson
Fish and Richardson
Cerilliant

Generated: January 23, 2018

DrugPatentWatch Database Preview

EDURANT Drug Profile

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When do Edurant patents expire, and what generic alternatives are available?

Edurant is a drug marketed by Janssen Prods and is included in one NDA. There are six patents protecting this drug.

This drug has two hundred and thirteen patent family members in thirty-nine countries.

The generic ingredient in EDURANT is rilpivirine hydrochloride. There are seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the rilpivirine hydrochloride profile page.

US Patents and Regulatory Information for EDURANT

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 ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Janssen Prods EDURANT rilpivirine hydrochloride TABLET;ORAL 202022-001 May 20, 2011 RX Yes Yes ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Janssen Prods EDURANT rilpivirine hydrochloride TABLET;ORAL 202022-001 May 20, 2011 RX Yes Yes ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Janssen Prods EDURANT rilpivirine hydrochloride TABLET;ORAL 202022-001 May 20, 2011 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Janssen Prods EDURANT rilpivirine hydrochloride TABLET;ORAL 202022-001 May 20, 2011 RX Yes Yes ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Janssen Prods EDURANT rilpivirine hydrochloride TABLET;ORAL 202022-001 May 20, 2011 RX Yes Yes ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Janssen Prods EDURANT rilpivirine hydrochloride TABLET;ORAL 202022-001 May 20, 2011 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Non-Orange Book US Patents for EDURANT

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
7,956,063 Salt of 4-[[4-[[4-(2-cyanoethenyl)-2,6-dimethylphenyl]amino]-2-pyrimidinyl- ]amino]benzonitrile ➤ Subscribe
8,841,310 Combinations of a pyrimidine containing NNRTI with RT inhibitors ➤ Subscribe
9,580,392 HIV replication inhibiting pyrimidines ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for EDURANT

Supplementary Protection Certificates for EDURANT

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0071 France ➤ Subscribe PRODUCT NAME: COMBINAISON DE RILPIVIRINE OU SES FORMES THERAPEUTIQUEMENT EQUIVALENTES PROTEGEES PAR LE BREVET DE BASE TELLES QUE LES SELS PHARMACEUTIQUEMENT ACCEPTABLES DE RILPIVIRINE Y COMPRIS LE SEL D'ACIDE CHLORHYDRIQUE DE RILPIVIRINE AINSI QUE D'EMTRICITABINE; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
2012 00021 Denmark ➤ Subscribe PRODUCT NAME: KOMBINATION AF RILPIVIRIN ELLER ET FARMACEUTISK ACCEPTABELT ADDITIONSSALT AF RILPIVIRIN, HERUNDER HYDROCHLORID ADDITIONSSALTET AF RILPIVIRIN, OG TENOFOVIR, NAVNLIG TENOFOVIRDISOPROXILFUMARAT; REG. NO/DATE: EU/1/11/737/001-002 20111128
0850 Netherlands ➤ Subscribe PRODUCT NAME: COMBINATIE VAN: -RILPIVIRINE OF EEN THERAPEUTISCH EQUIVALENTE VORM DAARVAN ZOALS BESCHERMD DOOR HET BASISOCTROOI, ZOALS EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN RILPIVIRINE, WAARONDER HET HYDROCHLORIDEZOUT VAN RILPIVIRINE; EN -TENOFOVIRALAFENAMIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER TENOFOVIRALAFENAMIDEFUMARAAT; REGISTRATION NO/DATE: EU/1/16/1112 20160623
0852 Netherlands ➤ Subscribe PRODUCT NAME: COMBINATIE VAN: - RILPIVIRINEHYDROCHLORIDE OF EEN THERAPEUTISCH EQUIVALENTE VORM DAARVAN ZOALS BESCHERMD DOOR HET BASISOCTROOI; - EMTRICITABINE; EN - TENOFOVIRALAFENAMIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER TENOFOVIRALAFENAMIDEFUMARAAT; REGISTRATION NO/DATE: EU/1/16/1112 20160623
/2015 Austria ➤ Subscribe PRODUCT NAME: KOMBINATION VON RILPIVIRIN ODER EINEM PHARMAZEUTISCH ANNEHMBAREN SALZ VON RILPIVIRIN, EINSCHLIESSLICH DES HYDROCHLORIDSALZES VON RILPIVIRIN, UND TENOFOVIR, INSBESONDERE TENOFOVIRDISOPROXILFUMARAT; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
2015035 Lithuania ➤ Subscribe PRODUCT NAME: RIPALVIRINUM + EMTRICITABINUM; REGISTRATION NO/DATE: EU/1/11/737/001, 2011 11 28 EU/1/11/737/002 20111128
2012009 Lithuania ➤ Subscribe PRODUCT NAME: EMTRICITABINUM + RILPIVIRINUM + TENOFOVIRUM DISOPROXILUM; REGISTRATION NO/DATE: EU/1/11/737/001, 2011 11 28 EU/1/11/737/002 20111128
C0073 France ➤ Subscribe PRODUCT NAME: COMBINAISON DE RILPIVIRINE OU SES FORMES THERAPEUTIQUEMENT EQUIVALENTES PROTEGEES PAR LE BREVET DE BASE TELLES QUE LES SELS PHARMACEUTIQUEMENT ACCEPTABLES DE RILPIVIRINE Y COMPRIS LE SEL D'ACIDE CHLORHYDRIQUE DE RILPIVIRINE DE TENOFOVIR EN PARTICULIER LE TENOFOVIR DISOPROXIL FUMARATE AINSI QUE D'EMTRICITABINE; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
2015 00056 Denmark ➤ Subscribe PRODUCT NAME: CERTIFIKAT; REG. NO/DATE: EU/1/11/737/001-002 20111128
00532 Netherlands ➤ Subscribe PRODUCT NAME: EEN COMBINATIE VAN RILPIVIRINE EN ELKE DOOR HET BASISOCTROOI BESCHERMDE THERAPEUTISCH EQUIVALENTE VORM DAARVAN,; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Farmers Insurance
AstraZeneca
Express Scripts
US Army
Fish and Richardson
Cipla
Mallinckrodt
Queensland Health
Argus Health

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