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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
Chubb
Federal Trade Commission
US Army
Johnson and Johnson
Moodys
Daiichi Sankyo
Express Scripts
Julphar

Generated: June 23, 2018

DrugPatentWatch Database Preview

JULUCA Drug Profile

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Which patents cover Juluca, and what generic alternatives are available?

Juluca is a drug marketed by Viiv Hlthcare and is included in one NDA. There are seven patents protecting this drug.

This drug has three hundred and twenty patent family members in forty-three countries.

The generic ingredient in JULUCA is dolutegravir sodium; rilpivirine hydrochloride. There are fifteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the dolutegravir sodium; rilpivirine hydrochloride profile page.
Drug patent expirations by year for JULUCA
Synonyms for JULUCA
Dolutegravir / rilpivirine
Dolutegravir and rilpivirine
Dolutegravir mixture with rilpivirine
S900007770

US Patents and Regulatory Information for JULUCA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Viiv Hlthcare JULUCA dolutegravir sodium; rilpivirine hydrochloride TABLET;ORAL 210192-001 Nov 21, 2017 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Viiv Hlthcare JULUCA dolutegravir sodium; rilpivirine hydrochloride TABLET;ORAL 210192-001 Nov 21, 2017 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Viiv Hlthcare JULUCA dolutegravir sodium; rilpivirine hydrochloride TABLET;ORAL 210192-001 Nov 21, 2017 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Viiv Hlthcare JULUCA dolutegravir sodium; rilpivirine hydrochloride TABLET;ORAL 210192-001 Nov 21, 2017 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
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 JULUCA

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
9,580,392 HIV replication inhibiting pyrimidines ➤ Sign Up
9,365,587 Synthesis of carbamoylpyridone HIV integrase inhibitors and intermediates ➤ Sign Up
8,410,103 (3S,11aR)-N-[2,4-difluorophenyl)methyl]-6-hydroxy-3-methyl-5,7-dioxo-2,3,5- ,7,11,11a-hexahydro[1,3]oxazolo[3,2-a]pyrido[1,2-d]pyrazine-8-carboxamide useful as anti-HIV agent ➤ Sign Up
7,638,522 Salt of 4-[[4-[[4-(2-cyanoethenyl)-2,6-dimethylphenyl]amino]-2-pyrimidinyl- ]amino] benzonitrile ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for JULUCA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0768 Netherlands ➤ Sign Up PRODUCT NAME: COMBINATIE VAN RILPIVIRINE OF EEN THERAPEUTISCH EQUIVALENTE VORM DAARVAN DIE BESCHERMD WORDT DOOR HET BASISOCTROOI, ZOALS EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN RILPIVIRINE, WAARONDER HET HYDROCHLORIDEZOUT VAN RILPIVIRINE. TENOFOVIR, IN HET BIJZONDER TENOFOVIRDISOPROXILFUMARAAT. EN EMTRICITABINE; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
15/052 Ireland ➤ Sign Up PRODUCT NAME: A COMBINATION OF RILPIVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT OF RILPIVIRINE, INCLUDING THE HYDROCHLORIDE SALT OF RILPIVIRINE, AND EMTRICITABINE; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
0781 Netherlands ➤ Sign Up PRODUCT NAME: COMBINATIE VAN RILPIVIRINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN RILPIVIRINE, WAARONDER HET HYDROCHLORIDEZOUT VAN RILPIVIRINE, EN EMTRICITABINE; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
2015 00055 Denmark ➤ Sign Up PRODUCT NAME: KOMBINATION AF RILPIVIRIN ELLER EN TERAPEUTISK AEKVIVALENT FORM DERAF, SOM ER BESKYTTET AF GRUNDPATENTET, SASOM ET FARMECEUTISK ACCEPTABELT SALT AF RILPIVIRIN, HERUNDER HYDROCHLORIDSALTET AF RILPIVIRIN, TENOFOVIR, NAVNLIG TENOFOVIRDISOPROXILFUMARAT; REG. NO/DATE: EU/1/11/737/001-002 20111128
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Julphar
Express Scripts
Citi
Mallinckrodt
Fuji
Chinese Patent Office
Cantor Fitzgerald
Federal Trade Commission
Daiichi Sankyo

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.