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TIVICAY Drug Profile

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When do Tivicay patents expire, and what generic alternatives are available?

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 thirty patent family members in thirty-three countries.

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

US ANDA Litigation and Generic Entry Outlook for Tivicay

Tivicay was eligible for patent challenges on August 12, 2017.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 8, 2029. This may change due to patent challenges or generic licensing.

There have been thirteen patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There are five tentative approvals for the generic drug (dolutegravir sodium), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for TIVICAY

International Patents:	130
US Patents:	2
Applicants:	1
NDAs:	1
Suppliers / Packagers:	3
Bulk Api Vendors:	75
Clinical Trials:	23
Patent Applications:	73
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for TIVICAY
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TIVICAY
DailyMed Link:	TIVICAY at DailyMed

See drug prices for TIVICAY

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.

Recent Clinical Trials for TIVICAY

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Frederick National Laboratory for Cancer Research	Phase 4
Instituto de Investigación Hospital Universitario La Paz	Phase 2
St. Stephens Clinical Research	Phase 1

See all TIVICAY clinical trials

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

Paragraph IV (Patent) Challenges for TIVICAY

Tradename	Dosage	Ingredient	NDA	Submissiondate
TIVICAY	TABLET;ORAL	dolutegravir sodium	204790	2017-08-14

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

International Patents for TIVICAY

Country	Patent Number	Estimated Expiration
Australia	2006239177
Philippines	12007502373
Norway	20075165
Slovenia	3045206
Mexico	2011006241
Poland	2465580
Japan	5317257

Supplementary Protection Certificates for TIVICAY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1874117	CA 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 20140116
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	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	C01874117/01	Switzerland		PRODUCT NAME: DOLUTEGRAVIR; REGISTRATION NO/DATE: SWISSMEDIC 63052 08.05.2014
2932970	PA2018013	Lithuania		PRODUCT NAME: DERINYS, APIMANTIS DOLUTEGRAVIRA ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA (PVZ., DOLUTEGRAVIRO NATRI) IR RILPIVIRINA ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA (PVZ., RILPIVIRINO HIDROCHLORIDA); REGISTRATION NO/DATE: EU/1/18/1282/001-002 20180516
2932970	300957	Netherlands		PRODUCT NAME: EEN COMBINATIE OMVATTENDE DOLUTEGRAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN (ZOALS DOLUTEGRAVIR NATRIUM) EN RILPIVIRINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN (ZOALS RILPIVIRINE HYDROCHLORIDE); REGISTRATION NO/DATE: NOT AVAILABLE
2932970	332 50016-2018	Slovakia		PRODUCT NAME: DOLUTEGRAVIR VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM/RILPIVIRIN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/18/1282/001 - EU/1/18/1282/002 20180518