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Dolutegravir sodium - Generic Drug Details

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

Dolutegravir sodium is the generic ingredient in three branded drugs marketed by Viiv Hlthcare and is included in three NDAs. There are seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Dolutegravir sodium has one hundred and twenty patent family members in thirty-three countries.

There are seventeen drug master file entries for dolutegravir sodium. Four suppliers are listed for this compound.

Summary for dolutegravir sodium

International Patents:	120
US Patents:	7
Tradenames:	3
Applicants:	1
NDAs:	3
Drug Master File Entries:	17
Suppliers / Packagers:	4
Bulk Api Vendors:	31
Clinical Trials:	1
Patent Applications:	4
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for dolutegravir sodium
DailyMed Link:	dolutegravir sodium at DailyMed

Pharmacology for dolutegravir sodium

Drug Class	Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor
Mechanism of Action	HIV Integrase Inhibitors Multidrug and Toxin Extrusion Transporter 1 Inhibitors Organic Cation Transporter 2 Inhibitors

Synonyms for dolutegravir sodium

1051375-19-9

1Q1V9V5WYQ

AK174049

AKOS025396662

B5856

BCP11890

CHEBI:76007

CHEMBL1213165

CS-3496

D10113

Dolutegravir (sodium)

Dolutegravir Sodium ( API)

Dolutegravir sodium (JAN/USAN)

Dolutegravir sodium [USAN]

Dolutegravir sodium(GSK1349572)

EX-A1694

FT-0697030

GSK 1349572A

GSK-1349572A

GSK1349572 sodiuM salt

GSK1349572A

GSK1349572sodiuMsalt;DOLUTEGRAVIRSODIUM;GSK1349572A;Dolutegravir sodiuM salt;Dolutegravir SodiuM ( API)

HY-13238A

KS-00000T34

MolPort-039-136-625

s4642

SCHEMBL19859120

sodium (4R,12aS)-9-[(2,4-difluorobenzyl)carbamoyl]-4-methyl-6,8-dioxo-3,4,6,8,12,12a-hexahydro-2H-pyrido[1',2':4,5]pyrazino[2,1-b][1,3]oxazin-7-olate

Tivicay (TN)

UNII-1Q1V9V5WYQ

US Patents and Regulatory Information for dolutegravir sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Viiv Hlthcare	TIVICAY	dolutegravir sodium	TABLET;ORAL	204790-003	Jun 9, 2016		RX	Yes	No
Viiv Hlthcare	JULUCA	dolutegravir sodium; rilpivirine hydrochloride	TABLET;ORAL	210192-001	Nov 21, 2017		RX	Yes	Yes			Y	Y
Viiv Hlthcare	TIVICAY	dolutegravir sodium	TABLET;ORAL	204790-001	Aug 12, 2013		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
Viiv Hlthcare	TIVICAY	dolutegravir sodium	TABLET;ORAL	204790-001	Aug 12, 2013		RX	Yes	Yes			Y	Y

International Patents for dolutegravir sodium

Country	Patent Number	Estimated Expiration
South Korea	101847887
Brazil	PI0610030
Denmark	1874117
Norway	20161315
Japan	2016041727
Brazil	PI0617842
Portugal	2465580

Supplementary Protection Certificates for dolutegravir sodium

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1874117	14C0041	France		PRODUCT NAME: DOLUTEGRAVIR ET SES SELS OU SOLVATES PHARMACEUTIQUEMENT ACCEPTABLES,NOTAMMENT LE DOLUTEGRAVIR SODIQUE.; REGISTRATION NO/DATE: EU/1/13/892/001-002 20140121
1874117	C 2014 024	Romania		PRODUCT NAME: DOLUTEGRAVIR SAU O SARE SAU SOLVAT AL ACESTUIAACCEPTABILE FARMACEUTIC, INCLUSIV DOLUTEGRAVIR DESODIU; NATIONAL AUTHORISATION NUMBER: EU/1/13/892; DATE OF NATIONAL AUTHORISATION: 20140116; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/892; DATE OF FIRST AUTHORISATION IN EEA: 20140116
1874117	202 50006-2014	Slovakia		PRODUCT NAME: SODNA SOL DOLUTEGRAVIRU; REGISTRATION NO/DATE: EU/1/13/892/001 - EU/1/13/892/002 20140121
1874117	300676	Netherlands		PRODUCT NAME: DOLUTEGRAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT DAARVAN, MET INBEGRIP VAN DOLUTEGRAVIR NATRIUM; REGISTRATION NO/DATE: EU/1/13/892 20140121
1874117	2014C/038	Belgium		PRODUCT NAME: DOULUTEGRAVIR SODIQUE; AUTHORISATION NUMBER AND DATE: EU/1/13/892 20140121
1874117	122014000066	Germany		PRODUCT NAME: DOLUTEGRAVIR ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER SOLVAT DAVON, EINSCHLIESSLICH DOLUTEGRAVIRNATRIUM; REGISTRATION NO/DATE: EU/1/13/892/001-002 20140116
1874117	CR 2014 00032	Denmark		PRODUCT NAME: DOLUTEGRAVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF, HERUNDER DOLUTEGRAVIRNATRIUM; REG. NO/DATE: EU/1/13/892/001-002 20140121