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TIVICAY Drug Profile

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Which patents cover Tivicay, and when can generic versions of Tivicay launch?

Tivicay is a drug marketed by Viiv Hlthcare and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and seven patent family members in thirty-one countries.

The generic ingredient in TIVICAY is dolutegravir sodium. There are fifteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the dolutegravir sodium profile page.

Summary for TIVICAY

International Patents:	107
US Patents:	2
Applicants:	1
NDAs:	1
Suppliers / Packagers:	2
Bulk Api Vendors:	24
Clinical Trials:	20
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TIVICAY
DailyMed Link:	TIVICAY at DailyMed

Generic Entry Opportunity Date for TIVICAY

NDA:

204790

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 TIVICAY

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 TIVICAY

1051375-19-9

1Q1V9V5WYQ

AK174049

AKOS025396662

B5856

CHEBI:76007

CHEMBL1213165

CS-3496

D10113

Dolutegravir (sodium)

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 TIVICAY

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	204790-002	Jun 9, 2016		RX	Yes	No			Y	Y
Viiv Hlthcare	TIVICAY	dolutegravir sodium	TABLET;ORAL	204790-003	Jun 9, 2016		RX	Yes	No
Viiv Hlthcare	TIVICAY	dolutegravir sodium	TABLET;ORAL	204790-002	Jun 9, 2016		RX	Yes	No
Viiv Hlthcare	TIVICAY	dolutegravir sodium	TABLET;ORAL	204790-001	Aug 12, 2013		RX	Yes	Yes

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Paragraph IV (Patent) Challenges for TIVICAY

Drugname	Dosage	Strength	RLD	Date
	Tablets	10 mg, 25 mg and 50 mg

Non-Orange Book US Patents for TIVICAY

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
9,051,337	Substituted 10-hydroxy-9,11-dioxo-2,3,4a,5,9,11,13,13a-octahydro-1h-pyrido[1,2-a]pyrr- olo[1',2':3,4]imidazo[1,2-d]pyrazine-8-carboxamides
9,273,065	Substituted pyrido[1',2':4,5]pyrazino[1,2-a]pyrimidines as HIV integrase inhibitors
7,858,788	Bicyclic carbamoylpyridone derivative having HIV integrase inhibitory activity
8,624,023	Synthesis of carbamoylpyridone HIV integrase inhibitors and intermediates

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International Patents for TIVICAY

Country	Document Number	Estimated Expiration
Australia	2006307101
European Patent Office	1874117
South Korea	20160003889
South Korea	20130133061

Supplementary Protection Certificates for TIVICAY

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0140020 00130	Estonia		PRODUCT NAME: DOLUTEGRAVIIR;REG NO/DATE: K(2014)305 (LOPLIK) 21.01.2014
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
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
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