Claim Your New User Special: Get your second month free ▶ Second Month Free

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Merck
McKinsey
Boehringer Ingelheim
Express Scripts
McKesson

Last Updated: May 26, 2022

JULUCA Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard

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 six patents protecting this drug and one Paragraph IV challenge.

This drug has four hundred and fifty-nine patent family members in fifty-four countries.

The generic ingredient in JULUCA is dolutegravir sodium; rilpivirine hydrochloride. There are seventeen 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.

DrugPatentWatch® Generic Entry Outlook for Juluca

Juluca was eligible for patent challenges on August 12, 2017.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 24, 2031. This may change due to patent challenges or generic licensing.

There have been twenty-two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

< Available with Subscription >

  Sign up for a Free Trial

Drug patent expirations by year for JULUCA
Drug Prices for JULUCA

See drug prices for JULUCA

DrugPatentWatch® Estimated Generic Entry Opportunity Date for JULUCA
Generic Entry Date for JULUCA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for JULUCA

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

SponsorPhase
Indiana UniversityPhase 4
ViiV HealthcarePhase 1
Janssen, LPPhase 1

See all JULUCA clinical trials

Paragraph IV (Patent) Challenges for JULUCA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
JULUCA Tablets dolutegravir sodium; rilpivirine hydrochloride 50 mg/25 mg 210192 1 2019-11-19

US Patents and Regulatory Information for JULUCA

JULUCA is protected by six US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of JULUCA is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting JULUCA

Antiviral therapy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HIV INFECTION

HIV inhibiting pyrimidines derivatives
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HIV INFECTION

HIV inhibiting pyrimidines derivatives
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Salt of 4-[[4-[[4-(2-cyanoethenyl)-2,6-dimethylphenyl]amino]-2-pyrimidinyl- ]amino]benzonitrile
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Substituted 5-hydroxy-3,4,6,9,9a, 10-hexanhydro-2h-1-oxa04a,8a-diaza-anthracene-6,10-dioness
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Synthesis of carbamoylpyridone HIV integrase inhibitors and intermediates
Patent Number: See Plans and Pricing
Patent Expiration: 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
Viiv Hlthcare JULUCA dolutegravir sodium; rilpivirine hydrochloride TABLET;ORAL 210192-001 Nov 21, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Viiv Hlthcare JULUCA dolutegravir sodium; rilpivirine hydrochloride TABLET;ORAL 210192-001 Nov 21, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Viiv Hlthcare JULUCA dolutegravir sodium; rilpivirine hydrochloride TABLET;ORAL 210192-001 Nov 21, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Viiv Hlthcare JULUCA dolutegravir sodium; rilpivirine hydrochloride TABLET;ORAL 210192-001 Nov 21, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Viiv Hlthcare JULUCA dolutegravir sodium; rilpivirine hydrochloride TABLET;ORAL 210192-001 Nov 21, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Viiv Hlthcare JULUCA dolutegravir sodium; rilpivirine hydrochloride TABLET;ORAL 210192-001 Nov 21, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y 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 JULUCA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Viiv Hlthcare JULUCA dolutegravir sodium; rilpivirine hydrochloride TABLET;ORAL 210192-001 Nov 21, 2017 See Plans and Pricing See Plans and Pricing
Viiv Hlthcare JULUCA dolutegravir sodium; rilpivirine hydrochloride TABLET;ORAL 210192-001 Nov 21, 2017 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for JULUCA

When does loss-of-exclusivity occur for JULUCA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

African Regional IP Organization (ARIPO)

Patent: 51
Estimated Expiration: See Plans and Pricing

Australia

Patent: 11209788
Estimated Expiration: See Plans and Pricing

Patent: 14202404
Estimated Expiration: See Plans and Pricing

Patent: 14202405
Estimated Expiration: See Plans and Pricing

Patent: 14202406
Estimated Expiration: See Plans and Pricing

Patent: 16204987
Estimated Expiration: See Plans and Pricing

Patent: 17268621
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2012018670
Estimated Expiration: See Plans and Pricing

Canada

Patent: 87691
Estimated Expiration: See Plans and Pricing

Patent: 67453
Estimated Expiration: See Plans and Pricing

Patent: 03988
Estimated Expiration: See Plans and Pricing

Patent: 60290
Estimated Expiration: See Plans and Pricing

Chile

Patent: 12002080
Estimated Expiration: See Plans and Pricing

China

Patent: 2791129
Estimated Expiration: See Plans and Pricing

Patent: 5311033
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 02152
Estimated Expiration: See Plans and Pricing

Costa Rica

Patent: 120423
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0150770
Estimated Expiration: See Plans and Pricing

Patent: 0180855
Estimated Expiration: See Plans and Pricing

Patent: 0181531
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 16509
Estimated Expiration: See Plans and Pricing

Patent: 20457
Estimated Expiration: See Plans and Pricing

Patent: 21040
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 31027
Estimated Expiration: See Plans and Pricing

Patent: 32970
Estimated Expiration: See Plans and Pricing

Patent: 27542
Estimated Expiration: See Plans and Pricing

Dominican Republic

Patent: 012000205
Estimated Expiration: See Plans and Pricing

Patent: 021000147
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 12012106
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 5176
Estimated Expiration: See Plans and Pricing

Patent: 2868
Estimated Expiration: See Plans and Pricing

Patent: 7601
Estimated Expiration: See Plans and Pricing

Patent: 1290583
Estimated Expiration: See Plans and Pricing

Patent: 1690872
Estimated Expiration: See Plans and Pricing

Patent: 1892277
Estimated Expiration: See Plans and Pricing

Patent: 2190473
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 31027
Estimated Expiration: See Plans and Pricing

Patent: 32970
Estimated Expiration: See Plans and Pricing

Patent: 27542
Estimated Expiration: See Plans and Pricing

Patent: 51249
Estimated Expiration: See Plans and Pricing

Patent: 94972
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 79522
Estimated Expiration: See Plans and Pricing

Patent: 09629
Estimated Expiration: See Plans and Pricing

Patent: 50335
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 26849
Estimated Expiration: See Plans and Pricing

Patent: 37812
Estimated Expiration: See Plans and Pricing

Patent: 40554
Estimated Expiration: See Plans and Pricing

Patent: 800042
Estimated Expiration: See Plans and Pricing

Israel

Patent: 1007
Estimated Expiration: See Plans and Pricing

Patent: 5182
Estimated Expiration: See Plans and Pricing

Patent: 7267
Estimated Expiration: See Plans and Pricing

Patent: 7658
Estimated Expiration: See Plans and Pricing

Patent: 1959
Estimated Expiration: See Plans and Pricing

Japan

Patent: 68386
Estimated Expiration: See Plans and Pricing

Patent: 13518107
Estimated Expiration: See Plans and Pricing

Patent: 16145204
Estimated Expiration: See Plans and Pricing

Patent: 17008087
Estimated Expiration: See Plans and Pricing

Patent: 18127473
Estimated Expiration: See Plans and Pricing

Patent: 19167371
Estimated Expiration: See Plans and Pricing

Patent: 21091705
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 2018013
Estimated Expiration: See Plans and Pricing

Patent: 32970
Estimated Expiration: See Plans and Pricing

Patent: 27542
Estimated Expiration: See Plans and Pricing

Luxembourg

Patent: 0090
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 6891
Estimated Expiration: See Plans and Pricing

Patent: 7937
Estimated Expiration: See Plans and Pricing

Patent: 7938
Estimated Expiration: See Plans and Pricing

Patent: 12008774
Estimated Expiration: See Plans and Pricing

Montenegro

Patent: 182
Estimated Expiration: See Plans and Pricing

Patent: 058
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 002
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 1319
Estimated Expiration: See Plans and Pricing

Patent: 7824
Estimated Expiration: See Plans and Pricing

Patent: 7826
Estimated Expiration: See Plans and Pricing

Patent: 7827
Estimated Expiration: See Plans and Pricing

Norway

Patent: 18036
Estimated Expiration: See Plans and Pricing

Patent: 32970
Estimated Expiration: See Plans and Pricing

Peru

Patent: 121524
Estimated Expiration: See Plans and Pricing

Patent: 160180
Estimated Expiration: See Plans and Pricing

Philippines

Patent: 016500195
Estimated Expiration: See Plans and Pricing

Patent: 018502489
Estimated Expiration: See Plans and Pricing

Poland

Patent: 31027
Estimated Expiration: See Plans and Pricing

Patent: 32970
Estimated Expiration: See Plans and Pricing

Patent: 27542
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 31027
Estimated Expiration: See Plans and Pricing

Patent: 32970
Estimated Expiration: See Plans and Pricing

Patent: 27542
Estimated Expiration: See Plans and Pricing

San Marino

Patent: 01500177
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 123
Estimated Expiration: See Plans and Pricing

Patent: 323
Estimated Expiration: See Plans and Pricing

Patent: 728
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 2614
Estimated Expiration: See Plans and Pricing

Patent: 201509476R
Estimated Expiration: See Plans and Pricing

Patent: 201707183T
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 31027
Estimated Expiration: See Plans and Pricing

Patent: 32970
Estimated Expiration: See Plans and Pricing

Patent: 27542
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1205586
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1830715
Estimated Expiration: See Plans and Pricing

Patent: 1883750
Estimated Expiration: See Plans and Pricing

Patent: 1964923
Estimated Expiration: See Plans and Pricing

Patent: 120128640
Estimated Expiration: See Plans and Pricing

Patent: 160111536
Estimated Expiration: See Plans and Pricing

Patent: 170078868
Estimated Expiration: See Plans and Pricing

Patent: 180078358
Estimated Expiration: See Plans and Pricing

Spain

Patent: 43066
Estimated Expiration: See Plans and Pricing

Patent: 70811
Estimated Expiration: See Plans and Pricing

Patent: 88925
Estimated Expiration: See Plans and Pricing

Tunisia

Patent: 12000376
Estimated Expiration: See Plans and Pricing

Turkey

Patent: 1807704
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 5556
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering JULUCA around the world.

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
Norway 2017062 See Plans and Pricing
Brazil PI0211909 compostos derivados de pirimidina que inibem o hiv, processos para as suas preparações e respectiva composição farmacêutica See Plans and Pricing
China 105311033 Antiviral therapy See Plans and Pricing
Portugal 1419152 See Plans and Pricing
China 101060844 Combinations of a pyrimidine containing nnrti with rt inhibitors See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for JULUCA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1663240 PA2015035 Lithuania See Plans and Pricing PRODUCT NAME: RIPALVIRINUM + EMTRICITABINUM; REGISTRATION NO/DATE: EU/1/11/737/001, 2011 11 28 EU/1/11/737/002 20111128
1419152 162 5010-2012 Slovakia See Plans and Pricing PRODUCT NAME: RILPIVIRINHYDROCHLORID/TENOFOVIRDIZOPROXILFUMARAT; REGISTRATION NO/DATE: EU/1/11/737/001 - EU/1/11/737/002 20111128
1419152 122012000038 Germany See Plans and Pricing PRODUCT NAME: KOMBINATION AUS RILPIVIRIN ODER EINER STEREOCHEMISCH ISOMEREN FORM ODER EINEM PHARMAZEUTISCH UNBEDENKLICHEN ADDITIONSSALZ DESSELBEN, EINSCHLIESSLICH DES CHLORWASSERSTOFFSAEURESALZES VON RILPIVIRIN, UND TENOFOVIR, INSBESONDERE TENOFOVIRDISOPROXILFUMARAT.; REGISTRATION NO/DATE: EU/1/11/737/001 20111128
1419152 PA2012009 Lithuania See Plans and Pricing PRODUCT NAME: EMTRICITABINUM + RILPIVIRINUM + TENOFOVIRUM DISOPROXILUM; REGISTRATION NO/DATE: EU/1/11/737/001, 2011 11 28 EU/1/11/737/002 20111128
1874117 PA2014021 Lithuania See Plans and Pricing PRODUCT NAME: DOLUTEGRAVIRUM NATRICUM; REGISTRATION NO/DATE: EU/1/13/892/001, 2014 01 16 EU/1/13/892/002 20140116
1663240 122015000085 Germany See Plans and Pricing PRODUCT NAME: KOMBINATION VON RILPIVIRIN ODER EINER THERAPEUTISCH AEQUIVALENTEN FORM DAVON, DIE DURCH DAS GRUNDPATENT GESCHUETZT IST, WIE Z.B EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ VON RILPIVIRIN, EINSCHLIESSLICH DES HYDROCHLORIDSALZES VON RILPIVIRIN, UND EMTRICITABIN; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Baxter
McKesson
McKinsey
AstraZeneca
Dow
Colorcon

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 verification 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.