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Last Updated: April 15, 2021

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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

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Drug patent expirations by year for TIVICAY
Drug Prices for TIVICAY

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DrugPatentWatch® Estimated Generic Entry Opportunity Date for TIVICAY
Generic Entry Date for TIVICAY*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
Chelsea and Westminster NHS Foundation TrustPhase 1
Frederick National Laboratory for Cancer ResearchPhase 4
Instituto de Investigación Hospital Universitario La PazPhase 2

See all TIVICAY clinical trials

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   Start Trial   Start Trial Y Y   Start Trial
Viiv Hlthcare TIVICAY dolutegravir sodium TABLET;ORAL 204790-001 Aug 12, 2013 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Viiv Hlthcare TIVICAY dolutegravir sodium TABLET;ORAL 204790-003 Jun 9, 2016 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Viiv Hlthcare TIVICAY dolutegravir sodium TABLET;ORAL 204790-001 Aug 12, 2013 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Viiv Hlthcare TIVICAY dolutegravir sodium TABLET;ORAL 204790-002 Jun 9, 2016 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Viiv Hlthcare TIVICAY dolutegravir sodium TABLET;ORAL 204790-002 Jun 9, 2016 RX Yes No   Start Trial   Start Trial   Start Trial
Viiv Hlthcare TIVICAY dolutegravir sodium TABLET;ORAL 204790-003 Jun 9, 2016 RX Yes No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for TIVICAY

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1874117 2014C/038 Belgium   Start Trial PRODUCT NAME: DOULUTEGRAVIR SODIQUE; AUTHORISATION NUMBER AND DATE: EU/1/13/892 20140121
2932970 LUC00090 Luxembourg   Start Trial 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   Start Trial PRODUCT NAME: DOLUTEGRAVIR; REGISTRATION NO/DATE: SWISSMEDIC 63052 08.05.2014
1874117 C300676 Netherlands   Start Trial 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   Start Trial 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   Start Trial 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   Start Trial PRODUCT NAME: DOLUTEGRAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT DAARVAN, MET INBEGRIP VAN DOLUTEGRAVIR NATRIUM; REGISTRATION NO/DATE: EU/1/13/892 20140121
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Express Scripts
McKesson
Harvard Business School
AstraZeneca
Merck
Medtronic

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