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Last Updated: July 13, 2024

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TIVICAY Drug Patent 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 fifty-five patent family members in thirty-five countries.

The generic ingredient in TIVICAY 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

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 June 8, 2030. 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

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Drug patent expirations by year for TIVICAY
Drug Prices for TIVICAY

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DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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
Chelsea and Westminster NHS Foundation TrustPhase 3
Frederick National Laboratory for Cancer ResearchPhase 4

See all TIVICAY clinical trials

Paragraph IV (Patent) Challenges for TIVICAY
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
TIVICAY Tablets dolutegravir sodium 10 mg, 25 mg and 50 mg 204790 4 2017-08-14

US Patents and Regulatory Information for TIVICAY

TIVICAY is protected by two US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of TIVICAY is ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

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

Substituted 5-hydroxy-3,4,6,9,9a, 10-hexanhydro-2h-1-oxa04a,8a-diaza-anthracene-6,10-dioness
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Synthesis of carbamoylpyridone HIV integrase inhibitors and intermediates
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Viiv Hlthcare TIVICAY PD dolutegravir sodium TABLET, FOR SUSPENSION;ORAL 213983-001 Jun 12, 2020 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Viiv Hlthcare TIVICAY dolutegravir sodium TABLET;ORAL 204790-003 Jun 9, 2016 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for TIVICAY

When does loss-of-exclusivity occur for TIVICAY?

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

Australia

Patent: 09325128
Patent: Synthesis of carbamoylpyridone HIV integrase inhibitors and intermediates
Estimated Expiration: ⤷  Sign Up

Patent: 14277831
Patent: SYNTHESIS OF CARBAMOYLPYRIDONE HIV INTEGRASE INHIBITORS AND INTERMEDIATES
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 0923217
Patent: processos para a preparação de um composto de piridona, e para a preparação de uma forma cristalina, composto, sal ou um hidrato deste, forma cristalina de um sal de sódio ou um hidrato deste, e, composição farmacêutica.
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 44019
Patent: SYNTHESE D'INHIBITEURS CARBAMOYLPYRIDONE DE L'INTEGRASE DU VIH ET INTERMEDIAIRES (SYNTHESIS OF CARBAMOYLPYRIDONE HIV INTEGRASE INHIBITORS AND INTERMEDIATES)
Estimated Expiration: ⤷  Sign Up

Patent: 55957
Patent: SYNTHESE D'INHIBITEURS CARBAMOYLPYRIDONE DE L'INTEGRASE DU VIH ET INTERMEDIAIRES (SYNTHESIS OF CARBAMOYLPYRIDONE HIV INTEGRASE INHIBITORS AND INTERMEDIATES)
Estimated Expiration: ⤷  Sign Up

China

Patent: 2245182
Patent: Synthesis of carbamoylpyridone HIV integrase inhibitors and intermediates
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 76080
Patent: SYNTHÈSE D'INHIBITEURS CARBAMOYLPYRIDONE DE L'INTÉGRASE DU VIH ET INTERMÉDIAIRES (SYNTHESIS OF CARBAMOYLPYRIDONE HIV INTEGRASE INHIBITORS AND INTERMEDIATES)
Estimated Expiration: ⤷  Sign Up

Patent: 10603
Patent: SYNTHÈSE D'INHIBITEURS CARBAMOYLPYRIDONE DE L'INTÉGRASE DU VIH ET INTERMÉDIAIRES (SYNTHESIS OF CARBAMOYLPYRIDONE HIV INTEGRASE INHIBITORS AND INTERMEDIATES)
Estimated Expiration: ⤷  Sign Up

Hong Kong

Patent: 43626
Patent: 氨基甲酰基吡啶酮HIV整合酶抑制劑和中間體的合成 (SYNTHESIS OF CARBAMOYLPYRIDONE HIV INTEGRASE INHIBITORS AND INTERMEDIATES)
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 86478
Estimated Expiration: ⤷  Sign Up

Patent: 48595
Estimated Expiration: ⤷  Sign Up

Patent: 30891
Estimated Expiration: ⤷  Sign Up

Patent: 12131791
Patent: SYNTHESIS OF CARBAMOYLPYRIDONE HIV INTEGRASE INHIBITORS AND THEIR INTERMEDIATES
Estimated Expiration: ⤷  Sign Up

Patent: 12511573
Estimated Expiration: ⤷  Sign Up

Patent: 16041727
Patent: カルバモイルピリドンHIVインテグラーゼ阻害剤及びそれらの中間体の合成 (SYNTHESIS OF CARBAMOYLPYRIDONE HIV INTEGRASE INHIBITORS AND THEIR INTERMEDIATES)
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 1942
Patent: SINTESIS DE INHIBIDORES DE INTEGRASA DE VIH DE CARBAMOIL-PIRIDONA E INTERMEDIARIOS. (SYNTHESIS OF CARBAMOYLPYRIDONE HIV INTEGRASE INHIBITORS AND INTERMEDIATES.)
Estimated Expiration: ⤷  Sign Up

Patent: 11006241
Patent: SINTESIS DE INHIBIDORES DE INTEGRASA DE VIH DE CARBAMOIL-PIRIDONA E INTERMEDIARIOS. (SYNTHESIS OF CARBAMOYLPYRIDONE HIV INTEGRASE INHIBITORS AND INTERMEDIATES.)
Estimated Expiration: ⤷  Sign Up

Russian Federation

Patent: 27451
Patent: СИНТЕЗ КАРБАМОИЛПИРИДОНОВЫХ ИНГИБИТОРОВ ИНТЕГРАЗЫ ВИЧ И ПРОМЕЖУТОЧНЫХ СОЕДИНЕНИЙ (SYNTHESIS OF CARBAMOYL PYRIDONE INHIBITORS OF HIV INTEGRASE AND INTERMEDIATE COMPOUNDS)
Estimated Expiration: ⤷  Sign Up

Patent: 38923
Patent: Синтез карбамоилпиридоновых ингибиторов интегразы ВИЧ и промежуточных соединений (SYNTHESIS OF CARBAMOIL-PYRIDONE INHIBITORS OF HIV INTEGRASE AND INTERMEDIATE COMPOUNDS)
Estimated Expiration: ⤷  Sign Up

Patent: 11121785
Patent: СИНТЕЗ КАРБАМОИЛПИРИДОНОВЫХ ИНГИБИТОРОВ ИНТЕГРАЗЫ ВИЧ И ПРОМЕЖУТОЧНЫХ СОЕДИНЕНИЙ
Estimated Expiration: ⤷  Sign Up

Patent: 13153004
Patent: СИНТЕЗ КАРБАМОИЛПИРИДОНОВЫХ ИНГИБИТОРОВ ИНТЕГРАЗЫ ВИЧ И ПРОМЕЖУТОЧНЫХ СОЕДИНЕНИЙ
Estimated Expiration: ⤷  Sign Up

Singapore

Patent: 1308
Patent: SYNTHESIS OF CARBAMOYLPYRIDONE HIV INTEGRASE INHIBITORS AND INTERMEDIATES
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 1733625
Estimated Expiration: ⤷  Sign Up

Patent: 1847887
Estimated Expiration: ⤷  Sign Up

Patent: 110094336
Patent: SYNTHESIS OF CARBAMOYLPYRIDONE HIV INTEGRASE INHIBITORS AND INTERMEDIATES
Estimated Expiration: ⤷  Sign Up

Patent: 170038116
Patent: 카르바모일피리돈 HIV 인테그라제 억제제 및 중간체의 합성 (SYNTHESIS OF CARBAMOYLPYRIDONE HIV INTEGRASE INHIBITORS AND INTERMEDIATES)
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 41765
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 83947
Estimated Expiration: ⤷  Sign Up

Patent: 1030010
Patent: Synthesis of carbamoylpyridone HIV integrase inhibitors and intermediates
Estimated Expiration: ⤷  Sign Up

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 around the world.

Country Patent Number Title Estimated Expiration
Denmark 3045206 ⤷  Sign Up
European Patent Office 3210603 SYNTHÈSE D'INHIBITEURS CARBAMOYLPYRIDONE DE L'INTÉGRASE DU VIH ET INTERMÉDIAIRES (SYNTHESIS OF CARBAMOYLPYRIDONE HIV INTEGRASE INHIBITORS AND INTERMEDIATES) ⤷  Sign Up
South Korea 20080009733 POLYCYCLIC CARBAMOYLPYRIDONE DERIVATIVE HAVING HIV INTEGRASE INHIBITORY ACTIVITY ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for TIVICAY

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2932970 42/2018 Austria ⤷  Sign Up 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 30/2014 Austria ⤷  Sign Up PRODUCT NAME: DOLUTEGRAVIR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER SOLVAT DAVON, EINSCHLIESSLICH DOLUTEGRAVIR-NATRIUM; REGISTRATION NO/DATE: EU/1/13/892/001-002 (MITTEILUNG) 20140121
2465580 17/2021 Austria ⤷  Sign Up PRODUCT NAME: CABOTEGRAVIR UND SALZE DAVON; REGISTRATION NO/DATE: EU/1/20/1481 (MITTEILUNG) 20201221
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.