DrugPatentWatch Database Preview

Dolutegravir sodium - Generic Drug Details

  Purchase this report

or, see our see our flat-rate plans

« Back to Dashboard

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 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.

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

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

Summary for dolutegravir sodium

International Patents:	107
US Patents:	7
Tradenames:	2
Applicants:	1
NDAs:	2
Drug Master File Entries:	15
Suppliers / Packagers:	2
Bulk Api Vendors:	22
Clinical Trials:	2,532
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	TIVICAY	dolutegravir sodium	TABLET;ORAL	204790-001	Aug 12, 2013		RX	Yes	Yes
Viiv Hlthcare	TIVICAY	dolutegravir sodium	TABLET;ORAL	204790-003	Jun 9, 2016		RX	Yes	No			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	204790-002	Jun 9, 2016		RX	Yes	No

  Purchase this report

or, see our see our flat-rate plans

Non-Orange Book US Patents for dolutegravir sodium

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
8,624,023	Synthesis of carbamoylpyridone HIV integrase inhibitors and intermediates
8,410,103	(3S,11aR)-N-[2,4-difluorophenyl)methyl]-6-hydroxy-3-methyl-5,7-dioxo-2,3,5- ,7,11,11a-hexahydro[1,3]oxazolo[3,2-a]pyrido[1,2-d]pyrazine-8-carboxamide useful as anti-HIV agent
7,858,788	Bicyclic carbamoylpyridone derivative having HIV integrase inhibitory activity
9,273,065	Substituted pyrido[1',2':4,5]pyrazino[1,2-a]pyrimidines as HIV integrase inhibitors

  Purchase this report

or, see our see our flat-rate plans

International Patents for dolutegravir sodium

Country	Document Number	Estimated Expiration
China	101346376
Australia	2006307101
Philippines	12007502373
South Africa	200803423

Supplementary Protection Certificates for dolutegravir sodium

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0676	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
0140020 00130	Estonia		PRODUCT NAME: DOLUTEGRAVIIR;REG NO/DATE: K(2014)305 (LOPLIK) 21.01.2014
7	Finland
2014021	Lithuania		PRODUCT NAME: DOLUTEGRAVIRUM NATRICUM; REGISTRATION NO/DATE: EU/1/13/892/001, 2014 01 16 EU/1/13/892/002 20140116