JULUCA Drug Patent Profile

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

See drug prices for JULUCA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for JULUCA

NDA:

210192

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

See all JULUCA clinical trials

Pharmacology for JULUCA

Drug Class	Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor
Mechanism of Action	HIV Integrase Inhibitors Multidrug and Toxin Extrusion Transporter 1 Inhibitors Non-Nucleoside Reverse Transcriptase Inhibitors Organic Cation Transporter 2 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for JULUCA

J05AG	Non-nucleoside reverse transcriptase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

J05AJ	Integrase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

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.

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

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			Y	Y
Viiv Hlthcare	JULUCA	dolutegravir sodium; rilpivirine hydrochloride	TABLET;ORAL	210192-001	Nov 21, 2017		RX	Yes	Yes			Y	Y
Viiv Hlthcare	JULUCA	dolutegravir sodium; rilpivirine hydrochloride	TABLET;ORAL	210192-001	Nov 21, 2017		RX	Yes	Yes			Y	Y
Viiv Hlthcare	JULUCA	dolutegravir sodium; rilpivirine hydrochloride	TABLET;ORAL	210192-001	Nov 21, 2017		RX	Yes	Yes			Y	Y

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
Viiv Hlthcare	JULUCA	dolutegravir sodium; rilpivirine hydrochloride	TABLET;ORAL	210192-001	Nov 21, 2017
Viiv Hlthcare	JULUCA	dolutegravir sodium; rilpivirine hydrochloride	TABLET;ORAL	210192-001	Nov 21, 2017
Viiv Hlthcare	JULUCA	dolutegravir sodium; rilpivirine hydrochloride	TABLET;ORAL	210192-001	Nov 21, 2017

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)

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Cyprus

Denmark

Dominican Republic

Ecuador

Eurasian Patent Organization

European Patent Office

Hong Kong

Hungary

Israel

Japan

Lithuania

Luxembourg

Malaysia

Mexico

Montenegro

Morocco

New Zealand

Norway

Peru

Philippines

Poland

Portugal

San Marino

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Tunisia

Turkey

Ukraine

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
Japan	2017008087	抗ウイルス療法 (ANTIVIRAL THERAPY)
New Zealand	553323	Hydrochloride of 4-[[4-[[4-(2-cyanoethenyl)-2,6-dimethylphenyl]amino]-2-pyrimidinyl]amino]benzonitrile, also named TMC278
Malaysia	188334	ANTIVIRAL THERAPY

Supplementary Protection Certificates for JULUCA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1663240	2015/054	Ireland		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		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		PRODUCT NAME: EDURANT - RILPIVIRIIN;REG NO/DATE: C(2011)8955 FINAL 28.11.2011
1632232	CA 2016 00066	Denmark		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