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Dolutegravir sodium - Generic Drug Details

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

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

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

Summary for dolutegravir sodium

US Patents:	7
Tradenames:	2
Applicants:	1
NDAs:	2
Drug Master File Entries:	17
Suppliers / Packagers:	2
Bulk Api Vendors:	24
Clinical Trials:	1
Patent Applications:	1
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

CHEBI:76007

CHEMBL1213165

CS-3496

D10113

Dolutegravir (sodium)

Dolutegravir sodium (JAN/USAN)

Dolutegravir sodium [USAN]

EX-A1694

FT-0697030

GSK 1349572A

GSK-1349572A

GSK1349572 sodiuM salt

GSK1349572A

HY-13238A

KS-00000T34

MolPort-039-136-625

s4642

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

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;Sodium (4R,12aS)-9-((2,4-difluorobenzyl)carbamoyl)-4-methyl-6,8-dioxo-3,4,6

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	JULUCA	dolutegravir sodium; rilpivirine hydrochloride	TABLET;ORAL	210192-001	Nov 21, 2017		RX	Yes	Yes
Viiv Hlthcare	TIVICAY	dolutegravir sodium	TABLET;ORAL	204790-001	Aug 12, 2013		RX	Yes	Yes
Viiv Hlthcare	TIVICAY	dolutegravir sodium	TABLET;ORAL	204790-001	Aug 12, 2013		RX	Yes	Yes

International Patents for dolutegravir sodium

Country	Document Number	Estimated Expiration
New Zealand	562339
Mexico	302718
Japan	2016041727

Supplementary Protection Certificates for dolutegravir sodium

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2014021,C1874117	Lithuania		PRODUCT NAME: DOLUTEGRAVIRAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA ARBA SOLVATAS, ISKAITANT DOLUTEGRAVIRO NATRIO DRUSKA; REGISTRATION NO/DATE: EU/1/13/892/001, 2014-01-16 EU/1/13/892/002 20140116
1874117/01	Switzerland		PRODUCT NAME: DOLUTEGRAVIR; REGISTRATION NO/DATE: SWISSMEDIC 63052 08.05.2014
14/032	Ireland		PRODUCT NAME: DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING DOLUTEGRAVIR SODIUM; REGISTRATION NO/DATE: EU/1/13/892/001-002 20140121