TIVICAY PD Drug Patent Profile

When do Tivicay Pd patents expire, and when can generic versions of Tivicay Pd launch?

Tivicay Pd 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 forty-eight patent family members in thirty-three countries.

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

DrugPatentWatch^® Generic Entry Outlook for Tivicay Pd

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 twenty 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 eight tentative approvals for the generic drug (dolutegravir sodium), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for TIVICAY PD

International Patents:	148
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	31
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for TIVICAY PD
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TIVICAY PD
What excipients (inactive ingredients) are in TIVICAY PD?	TIVICAY PD excipients list
DailyMed Link:	TIVICAY PD at DailyMed

See drug prices for TIVICAY PD

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for TIVICAY PD

NDA:

213983

Dosage:

TABLET, FOR SUSPENSION;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 PD

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

Sponsor	Phase
Chelsea and Westminster NHS Foundation Trust	Phase 1
Chelsea and Westminster NHS Foundation Trust	Phase 3
Frederick National Laboratory for Cancer Research	Phase 4

See all TIVICAY PD clinical trials

Pharmacology for TIVICAY PD

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

Anatomical Therapeutic Chemical (ATC) Classes for TIVICAY PD

J05AJ	Integrase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

Paragraph IV (Patent) Challenges for TIVICAY PD

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TIVICAY PD	Tablets for Suspension	dolutegravir sodium	5 mg	213983	1	2021-07-21

US Patents and Regulatory Information for TIVICAY PD

TIVICAY PD is protected by two US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting TIVICAY PD

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 PD	dolutegravir sodium	TABLET, FOR SUSPENSION;ORAL	213983-001	Jun 12, 2020		RX	Yes	Yes			Y	Y
Viiv Hlthcare	TIVICAY PD	dolutegravir sodium	TABLET, FOR SUSPENSION;ORAL	213983-001	Jun 12, 2020		RX	Yes	Yes			Y	Y

International Patents for TIVICAY PD

When does loss-of-exclusivity occur for TIVICAY PD?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

European Patent Office

Hong Kong

Japan

Mexico

Russian Federation

Singapore

South Korea

Spain

Taiwan

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering TIVICAY PD around the world.

Country	Patent Number	Title	Estimated Expiration
Mexico	302718	DERIVADO DE CARBAMOILPIRIDONA POLICICLICO QUE TIENE ACTIVIDAD INHIBIDORA DE LA INTEGRASA DE HIV. (POLYCYCLIC CARBAMOYLPYRIDONE DERIVATIVE HAVING HIV INTEGRASE INHIBITORY ACTIVITY.)
Spain	2446324
European Patent Office	2465580	Dérivés de carbamoylpyridone polycyclique dotés d'une activité inhibitrice de l'intégrase du VIH (Polycyclic carbamoylpyridone derivatives having hiv integrase inhibitory activity)
Poland	3284520

Supplementary Protection Certificates for TIVICAY PD

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2465580	C202130021	Spain		PRODUCT NAME: CABOTEGRAVIR; NATIONAL AUTHORISATION NUMBER: EU/1/20/1481; DATE OF AUTHORISATION: 20201217; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1481; DATE OF FIRST AUTHORISATION IN EEA: 20201217
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
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	202 50006-2014	Slovakia		PRODUCT NAME: SODNA SOL DOLUTEGRAVIRU; REGISTRATION NO/DATE: EU/1/13/892/001 - EU/1/13/892/002 20140121