Dolutegravir sodium; rilpivirine hydrochloride - Generic Drug Details

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What are the generic drug sources for dolutegravir sodium; rilpivirine hydrochloride and what is the scope of patent protection?

Dolutegravir sodium; rilpivirine hydrochloride is the generic ingredient in one branded drug marketed by Viiv Hlthcare and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Dolutegravir sodium; rilpivirine hydrochloride has five hundred and five patent family members in fifty-eight countries.

One supplier is listed for this compound.

Summary for dolutegravir sodium; rilpivirine hydrochloride

International Patents:	505
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for dolutegravir sodium; rilpivirine hydrochloride
DailyMed Link:	dolutegravir sodium; rilpivirine hydrochloride at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for dolutegravir sodium; rilpivirine hydrochloride

Generic Entry Date for dolutegravir sodium; rilpivirine hydrochloride^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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.

Pharmacology for dolutegravir sodium; rilpivirine hydrochloride

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 dolutegravir sodium; rilpivirine hydrochloride

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 DOLUTEGRAVIR SODIUM; RILPIVIRINE HYDROCHLORIDE

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 dolutegravir sodium; rilpivirine hydrochloride

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Glossary

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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			⤷ Sign Up
Viiv Hlthcare	JULUCA	dolutegravir sodium; rilpivirine hydrochloride	TABLET;ORAL	210192-001	Nov 21, 2017		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			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	⤷ Sign Up
>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 dolutegravir sodium; rilpivirine hydrochloride

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

International Patents for dolutegravir sodium; rilpivirine hydrochloride

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Country	Patent Number	Title	Estimated Expiration
Japan	2008511591		⤷ Sign Up
New Zealand	601319	Antiviral combinations involving (4r,12as)-n-[(2,4-difluorophenyl)methyl]-3,4,6,8,12,12a-hexahydro-7-hydroxy-4-methyl-6,8-dioxo-2h-pyrido[1’,2’:4,5]pyrazino[2,1-b][1,3]oxazine-9-carboxamide	⤷ Sign Up
Slovenia	3127542		⤷ Sign Up
Costa Rica	9032	FUMARATO DE 4-((4-((4-(2-CIANOETENIL)-2,6-DIMETILFENIL)AMINO-2- PIRIMIDINIL)AMINO)BENZONITRILO	⤷ Sign Up
Hong Kong	1092698	包含嘧啶的抑制劑的組合 (COMBINATIONS OF A PYRIMIDINE CONTAINING NNRTI WITH RT INHIBITORS NNRTI RT)	⤷ Sign Up
Russian Federation	2755710	Комбинация, ее применение и способы лечения с использованием указанной комбинации (COMBINATION, ITS APPLICATION AND METHODS FOR TREATMENT USING SPECIFIED COMBINATION)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for dolutegravir sodium; rilpivirine hydrochloride

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2465580	PA2021512	Lithuania	⤷ Sign Up	PRODUCT NAME: KABOTEGRAVIRAS; REGISTRATION NO/DATE: EU/1/20/1481 20201217
2465580	2190020-4	Sweden	⤷ Sign Up	PRODUCT NAME: CABOTEGRAVIR OR A PHAMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/20/1481 20201221
3494972	122024000031	Germany	⤷ Sign Up	PRODUCT NAME: DOLUTEGRAVIR, ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, EINSCHLIESSLICH DOLUTEGRAVIR-NATRIUM, MIT LAMIVUDIN; REGISTRATION NO/DATE: EU/1/19/1370 20190701
1419152	C20120012 00058	Estonia	⤷ Sign Up	PRODUCT NAME: EVIPLERA - EMTRITSITABIIN/RILPIVIRIIN (HUEDRO-;REG NO/DATE: C(2011)8956 FINAL 28.11.2011
1632232	122016000111	Germany	⤷ Sign Up	PRODUCT NAME: KOMBINATION VON RILPIVIRINHYDROCHLORID ODER EINER THERAPEUTISCH AEQUIVALENTEN, DURCH DAS GRUNDPATENT GESCHUETZTEN FORM DAVON, EMTRICITABIN UND TENOFOVIRALAFENAMID ODER EINEM PHARMAZEUTISCH AKZEPTABLEN SALZ DAVON, INSBESONDERE TENOFOVIRALAFENAMIDFUMARAT; REGISTRATION NO/DATE: EU/1/16/1112 20160621
3494972	LUC00346	Luxembourg	⤷ Sign Up	PRODUCT NAME: DOLUTEGRAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, Y COMPRIS LE DOLUTEGRAVIR SODIQUE, ET LAMIVUDINE; AUTHORISATION NUMBER AND DATE: EU/1/19/1370 20190703
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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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.