JULUCA Drug Patent 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 six patents protecting this drug and one Paragraph IV challenge.
This drug has four hundred and sixty-three patent family members in fifty-five 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-three 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
Summary for JULUCA
International Patents: | 463 |
US Patents: | 6 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 1 |
Clinical Trials: | 3 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for JULUCA |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for JULUCA |
What excipients (inactive ingredients) are in JULUCA? | JULUCA excipients list |
DailyMed Link: | JULUCA at DailyMed |


DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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
Sponsor | Phase |
---|---|
ViiV Healthcare | Phase 1/Phase 2 |
Janssen Research & Development, LLC | Phase 1/Phase 2 |
Indiana University | Phase 4 |
Pharmacology for JULUCA
Anatomical Therapeutic Chemical (ATC) Classes for JULUCA
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 ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF HIV INFECTION
HIV inhibiting pyrimidines derivatives
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF HIV INFECTION
HIV inhibiting pyrimidines derivatives
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Salt of 4-[[4-[[4-(2-cyanoethenyl)-2,6-dimethylphenyl]amino]-2-pyrimidinyl- ]amino]benzonitrile
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Substituted 5-hydroxy-3,4,6,9,9a, 10-hexanhydro-2h-1-oxa04a,8a-diaza-anthracene-6,10-dioness
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Synthesis of carbamoylpyridone HIV integrase inhibitors and intermediates
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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 | ⤷ Try a Trial | ⤷ Try a Trial |
Viiv Hlthcare | JULUCA | dolutegravir sodium; rilpivirine hydrochloride | TABLET;ORAL | 210192-001 | Nov 21, 2017 | ⤷ Try a Trial | ⤷ Try a Trial |
Viiv Hlthcare | JULUCA | dolutegravir sodium; rilpivirine hydrochloride | TABLET;ORAL | 210192-001 | Nov 21, 2017 | ⤷ Try a Trial | ⤷ Try a Trial |
Viiv Hlthcare | JULUCA | dolutegravir sodium; rilpivirine hydrochloride | TABLET;ORAL | 210192-001 | Nov 21, 2017 | ⤷ Try a Trial | ⤷ Try a Trial |
>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: ⤷ Try a Trial
Australia
Patent: 11209788
Estimated Expiration: ⤷ Try a Trial
Patent: 14202404
Estimated Expiration: ⤷ Try a Trial
Patent: 14202405
Estimated Expiration: ⤷ Try a Trial
Patent: 14202406
Estimated Expiration: ⤷ Try a Trial
Patent: 16204987
Estimated Expiration: ⤷ Try a Trial
Patent: 17268621
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 2012018670
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 87691
Estimated Expiration: ⤷ Try a Trial
Patent: 67453
Estimated Expiration: ⤷ Try a Trial
Patent: 03988
Estimated Expiration: ⤷ Try a Trial
Patent: 60290
Estimated Expiration: ⤷ Try a Trial
Chile
Patent: 12002080
Estimated Expiration: ⤷ Try a Trial
China
Patent: 2791129
Estimated Expiration: ⤷ Try a Trial
Patent: 5311033
Estimated Expiration: ⤷ Try a Trial
Colombia
Patent: 02152
Estimated Expiration: ⤷ Try a Trial
Costa Rica
Patent: 120423
Estimated Expiration: ⤷ Try a Trial
Croatia
Patent: 0150770
Estimated Expiration: ⤷ Try a Trial
Patent: 0180855
Estimated Expiration: ⤷ Try a Trial
Patent: 0181531
Estimated Expiration: ⤷ Try a Trial
Cyprus
Patent: 16509
Estimated Expiration: ⤷ Try a Trial
Patent: 20457
Estimated Expiration: ⤷ Try a Trial
Patent: 21040
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 31027
Estimated Expiration: ⤷ Try a Trial
Patent: 32970
Estimated Expiration: ⤷ Try a Trial
Patent: 27542
Estimated Expiration: ⤷ Try a Trial
Dominican Republic
Patent: 012000205
Estimated Expiration: ⤷ Try a Trial
Patent: 021000147
Estimated Expiration: ⤷ Try a Trial
Ecuador
Patent: 12012106
Estimated Expiration: ⤷ Try a Trial
Eurasian Patent Organization
Patent: 5176
Estimated Expiration: ⤷ Try a Trial
Patent: 2868
Estimated Expiration: ⤷ Try a Trial
Patent: 7601
Estimated Expiration: ⤷ Try a Trial
Patent: 1290583
Estimated Expiration: ⤷ Try a Trial
Patent: 1690872
Estimated Expiration: ⤷ Try a Trial
Patent: 1892277
Estimated Expiration: ⤷ Try a Trial
Patent: 2190473
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 31027
Estimated Expiration: ⤷ Try a Trial
Patent: 32970
Estimated Expiration: ⤷ Try a Trial
Patent: 27542
Estimated Expiration: ⤷ Try a Trial
Patent: 51249
Estimated Expiration: ⤷ Try a Trial
Patent: 94972
Estimated Expiration: ⤷ Try a Trial
Hong Kong
Patent: 79522
Estimated Expiration: ⤷ Try a Trial
Patent: 09629
Estimated Expiration: ⤷ Try a Trial
Patent: 50335
Estimated Expiration: ⤷ Try a Trial
Hungary
Patent: 26849
Estimated Expiration: ⤷ Try a Trial
Patent: 37812
Estimated Expiration: ⤷ Try a Trial
Patent: 40554
Estimated Expiration: ⤷ Try a Trial
Patent: 800042
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 1007
Estimated Expiration: ⤷ Try a Trial
Patent: 5182
Estimated Expiration: ⤷ Try a Trial
Patent: 7267
Estimated Expiration: ⤷ Try a Trial
Patent: 7658
Estimated Expiration: ⤷ Try a Trial
Patent: 1959
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 68386
Estimated Expiration: ⤷ Try a Trial
Patent: 13518107
Estimated Expiration: ⤷ Try a Trial
Patent: 16145204
Estimated Expiration: ⤷ Try a Trial
Patent: 17008087
Estimated Expiration: ⤷ Try a Trial
Patent: 18127473
Estimated Expiration: ⤷ Try a Trial
Patent: 19167371
Estimated Expiration: ⤷ Try a Trial
Patent: 21091705
Estimated Expiration: ⤷ Try a Trial
Patent: 22071126
Estimated Expiration: ⤷ Try a Trial
Lithuania
Patent: 932970
Estimated Expiration: ⤷ Try a Trial
Patent: 2018013
Estimated Expiration: ⤷ Try a Trial
Patent: 32970
Estimated Expiration: ⤷ Try a Trial
Patent: 27542
Estimated Expiration: ⤷ Try a Trial
Luxembourg
Patent: 0090
Estimated Expiration: ⤷ Try a Trial
Malaysia
Patent: 8334
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 6891
Estimated Expiration: ⤷ Try a Trial
Patent: 7937
Estimated Expiration: ⤷ Try a Trial
Patent: 7938
Estimated Expiration: ⤷ Try a Trial
Patent: 12008774
Estimated Expiration: ⤷ Try a Trial
Montenegro
Patent: 182
Estimated Expiration: ⤷ Try a Trial
Patent: 058
Estimated Expiration: ⤷ Try a Trial
Morocco
Patent: 002
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 1319
Estimated Expiration: ⤷ Try a Trial
Patent: 7824
Estimated Expiration: ⤷ Try a Trial
Patent: 7826
Estimated Expiration: ⤷ Try a Trial
Patent: 7827
Estimated Expiration: ⤷ Try a Trial
Norway
Patent: 18036
Estimated Expiration: ⤷ Try a Trial
Patent: 32970
Estimated Expiration: ⤷ Try a Trial
Peru
Patent: 121524
Estimated Expiration: ⤷ Try a Trial
Patent: 160180
Estimated Expiration: ⤷ Try a Trial
Philippines
Patent: 016500195
Estimated Expiration: ⤷ Try a Trial
Patent: 018502489
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 31027
Estimated Expiration: ⤷ Try a Trial
Patent: 32970
Estimated Expiration: ⤷ Try a Trial
Patent: 27542
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 31027
Estimated Expiration: ⤷ Try a Trial
Patent: 32970
Estimated Expiration: ⤷ Try a Trial
Patent: 27542
Estimated Expiration: ⤷ Try a Trial
San Marino
Patent: 01500177
Estimated Expiration: ⤷ Try a Trial
Serbia
Patent: 123
Estimated Expiration: ⤷ Try a Trial
Patent: 323
Estimated Expiration: ⤷ Try a Trial
Patent: 728
Estimated Expiration: ⤷ Try a Trial
Singapore
Patent: 2614
Estimated Expiration: ⤷ Try a Trial
Patent: 201509476R
Estimated Expiration: ⤷ Try a Trial
Patent: 201707183T
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 31027
Estimated Expiration: ⤷ Try a Trial
Patent: 32970
Estimated Expiration: ⤷ Try a Trial
Patent: 27542
Estimated Expiration: ⤷ Try a Trial
South Africa
Patent: 1205586
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 1830715
Estimated Expiration: ⤷ Try a Trial
Patent: 1883750
Estimated Expiration: ⤷ Try a Trial
Patent: 1964923
Estimated Expiration: ⤷ Try a Trial
Patent: 120128640
Estimated Expiration: ⤷ Try a Trial
Patent: 160111536
Estimated Expiration: ⤷ Try a Trial
Patent: 170078868
Estimated Expiration: ⤷ Try a Trial
Patent: 180078358
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 43066
Estimated Expiration: ⤷ Try a Trial
Patent: 70811
Estimated Expiration: ⤷ Try a Trial
Patent: 88925
Estimated Expiration: ⤷ Try a Trial
Tunisia
Patent: 12000376
Estimated Expiration: ⤷ Try a Trial
Turkey
Patent: 1807704
Estimated Expiration: ⤷ Try a Trial
Ukraine
Patent: 5556
Estimated Expiration: ⤷ Try a Trial
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 |
---|---|---|---|
New Zealand | 562339 | Polycyclic carbamoylpyridone derivative having HIV integrase inhibitory activity | ⤷ Try a Trial |
Japan | 2017008087 | 抗ウイルス療法 (ANTIVIRAL THERAPY) | ⤷ Try a Trial |
New Zealand | 553323 | Hydrochloride of 4-[[4-[[4-(2-cyanoethenyl)-2,6-dimethylphenyl]amino]-2-pyrimidinyl]amino]benzonitrile, also named TMC278 | ⤷ Try a Trial |
Malaysia | 188334 | ANTIVIRAL THERAPY | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for JULUCA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1663240 | 2015/054 | Ireland | ⤷ Try a Trial | 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 |
2932970 | LUC00090 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: COMBINAISON COMPRENANT DU DOLUTEGRAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (PAR EXEMPLE LE DOLUTEGRAVIR SODIQUE) ET LA RILPIVIRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (PAR EXEMPLE LE CHLORHYDRATE DE RILPIVIRINE); AUTHORISATION NUMBER AND DATE: EU/1/18/1282 20180518 |
1419152 | C20120010 00057 | Estonia | ⤷ Try a Trial | PRODUCT NAME: EDURANT - RILPIVIRIIN;REG NO/DATE: C(2011)8955 FINAL 28.11.2011 |
1632232 | CA 2016 00066 | Denmark | ⤷ Try a Trial | PRODUCT NAME: EN KOMBINATION AF: RILPIVIRINHYDROCHLORID ELLER EN TERAPEUTISK AEKVIVALENT FORM DERAF SOM ER BESKYTTET AF GRUNDPATENTET, EMTRICITABIN OG TENOFOVIRALAFENAMID, ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, SAERLIGT TENOFOVIRALAFENAMIDFUMARAT; REG. NO/DATE: EU/1/16/1112/001 20160623 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |