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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 two NDAs. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and thirty-three 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. Four suppliers are listed for this compound. Additional details are available on the dolutegravir sodium profile page.

DrugPatentWatch^® 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 sixteen 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:	133
US Patents:	2
Applicants:	1
NDAs:	2
Suppliers / Packagers:	4
Bulk Api Vendors:	104
Clinical Trials:	24
Patent Applications:	836
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for TIVICAY
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TIVICAY
What excipients (inactive ingredients) are in TIVICAY?	TIVICAY excipients list
DailyMed Link:	TIVICAY at DailyMed

See drug prices for TIVICAY

DrugPatentWatch^® Estimated 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
Chelsea and Westminster NHS Foundation Trust	Phase 1
Frederick National Laboratory for Cancer Research	Phase 4
Instituto de Investigación Hospital Universitario La Paz	Phase 2

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
Taiwan	I378931
Norway	2017010
Israel	186555
Cyprus	1116331
Singapore	171308
Mexico	2011006241
World Intellectual Property Organization (WIPO)	2006116764

Supplementary Protection Certificates for TIVICAY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1874117	2014C/038	Belgium		PRODUCT NAME: DOULUTEGRAVIR SODIQUE; AUTHORISATION NUMBER AND DATE: EU/1/13/892 20140121
2932970	LUC00090	Luxembourg		PRODUCT NAME: COMBINAISON COMPRENANT DU DOLUTEGRAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (PAR EXEMPLE LE DOLUTEGRAVIR SODIQUE) ET LA RILPIVIRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (PAR EXEMPLE LE CHLORHYDRATE DE RILPIVIRINE); AUTHORISATION NUMBER AND DATE: EU/1/18/1282 20180518
1874117	C01874117/01	Switzerland		PRODUCT NAME: DOLUTEGRAVIR; REGISTRATION NO/DATE: SWISSMEDIC 63052 08.05.2014
1874117	C300676	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	2014/032	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
2932970	42/2018	Austria		PRODUCT NAME: DOLUTEGRAVIR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON (Z.B. DOLUTEGRAVIR NATRIUM) UND RILPIVIRIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON (Z.B. RILPIVIRIN-HYDROCHLORID); REGISTRATION NO/DATE: EU/1/18/1282/001-002 (MITTEILUNG) 20180518
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